Skip to content
Triangle logo TriangleGet started
← Back to this collection

LABELS · cd9bea2a-6045-452d-9ac5-e70d08e9e26f

zoledronic acid

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2025-03-11
Captured
2026-09-09T23:37:58.719708+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Zoledronic Acid Injection is a bisphosphonate indicated for the treatment of: Hypercalcemia of malignancy. ( 1.1 ) Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. ( 1.2 ) Limitations of Use : The safety and efficacy of Zoledronic Acid Injection has not been established for use in hyperparathyroidism or non-tumor-related hypercalcemia. 1.1 Hypercalcemia of Malignancy Zoledronic Acid Injection is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cCa) of greater than or equal to 12 mg/dL [3 mmol/L] using the formula: cCa in mg/dL = Ca in mg/dL + 0.8 (4 g/dL – patient albumin [1g/dL]). 1.2 Multiple Myeloma and Bone Metastases of Solid Tumors Zoledronic Acid Injection is indicated for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. Limitations of Use The safety and efficacy of Zoledronic Acid Injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions have not been established.
Full extracted label fields
application numbers
  1. NDA203231
boxed warning exact
    brand names
    1. zoledronic acid
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=567578e6-cd2d-4339-b0f6-7a15444c0639
    generic names
    1. ZOLEDRONIC ACID
    id
    cd9bea2a-6045-452d-9ac5-e70d08e9e26f
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Zoledronic Acid Injection is a bisphosphonate indicated for the treatment of: Hypercalcemia of malignancy. ( 1.1 ) Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. ( 1.2 ) Limitations of Use : The safety and efficacy of Zoledronic Acid Injection has not been established for use in hyperparathyroidism or non-tumor-related hypercalcemia. 1.1 Hypercalcemia of Malignancy Zoledronic Acid Injection is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cCa) of greater than or equal to 12 mg/dL [3 mmol/L] using the formula: cCa in mg/dL = Ca in mg/dL + 0.8 (4 g/dL – patient albumin [1g/dL]). 1.2 Multiple Myeloma and Bone Metastases of Solid Tumors Zoledronic Acid Injection is indicated for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. Limitations of Use The safety and efficacy of Zoledronic Acid Injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions have not been established.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Sagent Pharmaceuticals
      matched search terms
      1. cancer
      2. myeloma
      3. tumor
      4. tumors
      5. malignancy
      package ndcs
      1. 25021-826-82
      2. 25021-826-87
      product ndcs
      1. 25021-826
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRAVENOUS
        rxcuis
        1. 1114085
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00600.json
        meta
        disclaimer
        Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
        last updated
        2026-09-09
        results
        limit
        100
        skip
        600
        total
        830
        sha256
        a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
        url
        https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=600&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22cd9bea2a-6045-452d-9ac5-e70d08e9e26f%22
        spl effective date
        2025-03-11
        spl effective time
        20250311
        spl set id
        567578e6-cd2d-4339-b0f6-7a15444c0639
        spl version
        21
        substance names
        1. ZOLEDRONIC ACID
        uniis
        1. 6XC1PAD3KF
        verification flags
        1. oncology_keyword_candidate_not_clinically_classified
        2. spl_text_not_verified_identical_to_latest_approved_label
        3. individual_indications_not_split_or_reconciled
        Drugs@FDA application source records
        1. application number
          NDA203231
          payload
          all indexed label documents
          1. Appl No
            203231
            Application Docs Date
            2013-08-06 00:00:00
            Application Docs ID
            19449
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            203231
            Application Docs Date
            2014-12-11 00:00:00
            Application Docs ID
            19450
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            6
            Submission Type
            SUPPL
          3. Appl No
            203231
            Application Docs Date
            2016-03-29 00:00:00
            Application Docs ID
            19451
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            11
            Submission Type
            SUPPL
          4. Appl No
            203231
            Application Docs Date
            2014-05-06 00:00:00
            Application Docs ID
            40278
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            2
            Submission Type
            SUPPL
          5. Appl No
            203231
            Application Docs Date
            2014-12-11 00:00:00
            Application Docs ID
            40279
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            5
            Submission Type
            SUPPL
          6. Appl No
            203231
            Application Docs Date
            2014-12-11 00:00:00
            Application Docs ID
            40280
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            7
            Submission Type
            SUPPL
          7. Appl No
            203231
            Application Docs Date
            2015-10-15 00:00:00
            Application Docs ID
            40281
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            10
            Submission Type
            SUPPL
          8. Appl No
            203231
            Application Docs Date
            2017-02-03 00:00:00
            Application Docs ID
            47093
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            13
            Submission Type
            SUPPL
          9. Appl No
            203231
            Application Docs Date
            2020-10-29 00:00:00
            Application Docs ID
            65069
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            16
            Submission Type
            SUPPL
          10. Appl No
            203231
            Application Docs Date
            2020-10-29 00:00:00
            Application Docs ID
            65070
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            17
            Submission Type
            SUPPL
          11. Appl No
            203231
            Application Docs Date
            2022-04-06 00:00:00
            Application Docs ID
            70705
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            19
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            203231
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            19
            Submission Status
            AP
            Submission Status Date
            2022-04-05 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          2. Appl No
            203231
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            17
            Submission Status
            AP
            Submission Status Date
            2020-10-27 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            203231
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            16
            Submission Status
            AP
            Submission Status Date
            2020-10-27 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            203231
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            15
            Submission Status
            AP
            Submission Status Date
            2020-10-27 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            203231
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            13
            Submission Status
            AP
            Submission Status Date
            2017-02-02 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            203231
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            11
            Submission Status
            AP
            Submission Status Date
            2016-03-25 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            203231
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            10
            Submission Status
            AP
            Submission Status Date
            2015-10-08 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            203231
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            9
            Submission Status
            AP
            Submission Status Date
            2015-08-31 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            203231
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            8
            Submission Status
            AP
            Submission Status Date
            2015-08-31 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            203231
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            7
            Submission Status
            AP
            Submission Status Date
            2014-12-10 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            203231
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            6
            Submission Status
            AP
            Submission Status Date
            2014-12-10 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          12. Appl No
            203231
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            5
            Submission Status
            AP
            Submission Status Date
            2014-12-10 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA203231
          approval interpretation
          Application linkage and approved submission are not indication-level current approval verification
          current indication status
          not_reconciled
          has approved submission record
          true
          latest approved submission date
          2022-04-05
          latest label selection rule
          max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
          latest posted label documents
          1. Appl No
            203231
            Application Docs Date
            2022-04-06 00:00:00
            Application Docs ID
            70705
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            19
            Submission Type
            SUPPL
          official application record
          Appl No
          203231
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          INFORLIFE
          openfda application present
          true
          products
          1. Active Ingredient
            ZOLEDRONIC ACID
            Appl No
            203231
            Drug Name
            ZOLEDRONIC ACID
            Form
            INJECTABLE;INTRAVENOUS
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            EQ 4MG BASE/100ML
            marketing status
            1. Prescription

        Source passages and status connections

        Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

        Passage 1 · positive indication candidate
        application numbers
        1. NDA203231
        brand names
        1. zoledronic acid
        classification reasons
        1. explicit_positive_indication_predicate
        2. supportive_or_complication_use_words
        clinical review status
        pending
        content role
        positive_indication_candidate
        context span
        end
        330
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE Zoledronic Acid Injection is a bisphosphonate indicated for the treatment of: Hypercalcemia of malignancy. ( 1.1 ) Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed afte
        label id
        cd9bea2a-6045-452d-9ac5-e70d08e9e26f
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        b0baed267b743ab89f76c1b265ccd1538909b2ce7eb29a37202a58986bc74e1c
        start
        0
        current approval status
        not_reconciled
        duplicate text group
        dup-898239984c9f19351052
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. ZOLEDRONIC ACID
        id
        ind-span-320d25a739a0292d6a0f
        label id
        cd9bea2a-6045-452d-9ac5-e70d08e9e26f
        positive predicate support span
        end
        79
        end exclusive
        true
        exact text
        is a bisphosphonate indicated
        label id
        cd9bea2a-6045-452d-9ac5-e70d08e9e26f
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        b0baed267b743ab89f76c1b265ccd1538909b2ce7eb29a37202a58986bc74e1c
        start
        50
        qualifier mentions
          regulatory links
            schema version
            0.1.0
            source batch sha256
            a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
            source defined aliases
              source span
              end
              130
              end exclusive
              true
              exact text
              1 INDICATIONS AND USAGE Zoledronic Acid Injection is a bisphosphonate indicated for the treatment of: Hypercalcemia of malignancy.
              label id
              cd9bea2a-6045-452d-9ac5-e70d08e9e26f
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              b0baed267b743ab89f76c1b265ccd1538909b2ce7eb29a37202a58986bc74e1c
              start
              0
              source url
              https://api.fda.gov/drug/label.json?search=id%3A%22cd9bea2a-6045-452d-9ac5-e70d08e9e26f%22
              spl effective date
              2025-03-11
              spl set id
              567578e6-cd2d-4339-b0f6-7a15444c0639
              spl version
              21
              structured fields status
              not_extracted_no_values_inferred_from_mentions
              structured indication
              age
              Source null
              approval pathway
              Source null
              biomarker and test
              Source null
              disease stage
              Source null
              limitations
              Source null
              line
              Source null
              prior therapy
              Source null
              regimen
              Source null
              tumor histology
              Source null
              use intent
              supportive_care_candidate
              Passage 2 · unclassified context
              application numbers
              1. NDA203231
              brand names
              1. zoledronic acid
              classification reasons
              1. no_unambiguous_positive_indication_predicate
              clinical review status
              pending
              content role
              unclassified_context
              context span
              end
              338
              end exclusive
              true
              exact text
              1 INDICATIONS AND USAGE Zoledronic Acid Injection is a bisphosphonate indicated for the treatment of: Hypercalcemia of malignancy. ( 1.1 ) Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatm
              label id
              cd9bea2a-6045-452d-9ac5-e70d08e9e26f
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              b0baed267b743ab89f76c1b265ccd1538909b2ce7eb29a37202a58986bc74e1c
              start
              0
              current approval status
              not_reconciled
              duplicate text group
              dup-676f1a24cea64b2aabd4
              extraction review status
              automated_candidate_pending_source_review
              generic names
              1. ZOLEDRONIC ACID
              id
              ind-span-729dd06c88c8a5866de5
              label id
              cd9bea2a-6045-452d-9ac5-e70d08e9e26f
              positive predicate support span
              Source null
              qualifier mentions
                regulatory links
                  schema version
                  0.1.0
                  source batch sha256
                  a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
                  source defined aliases
                    source span
                    end
                    138
                    end exclusive
                    true
                    exact text
                    ( 1.1 )
                    label id
                    cd9bea2a-6045-452d-9ac5-e70d08e9e26f
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    b0baed267b743ab89f76c1b265ccd1538909b2ce7eb29a37202a58986bc74e1c
                    start
                    131
                    source url
                    https://api.fda.gov/drug/label.json?search=id%3A%22cd9bea2a-6045-452d-9ac5-e70d08e9e26f%22
                    spl effective date
                    2025-03-11
                    spl set id
                    567578e6-cd2d-4339-b0f6-7a15444c0639
                    spl version
                    21
                    structured fields status
                    not_extracted_no_values_inferred_from_mentions
                    structured indication
                    age
                    Source null
                    approval pathway
                    Source null
                    biomarker and test
                    Source null
                    disease stage
                    Source null
                    limitations
                    Source null
                    line
                    Source null
                    prior therapy
                    Source null
                    regimen
                    Source null
                    tumor histology
                    Source null
                    use intent
                    unclear
                    Passage 3 · positive indication candidate
                    application numbers
                    1. NDA203231
                    brand names
                    1. zoledronic acid
                    classification reasons
                    1. inherited_predicate_from_same_label_section_requires_review
                    2. tumor_or_malignant_hematology_words_in_positive_statement
                    clinical review status
                    pending
                    content role
                    positive_indication_candidate
                    context span
                    end
                    486
                    end exclusive
                    true
                    exact text
                    1 INDICATIONS AND USAGE Zoledronic Acid Injection is a bisphosphonate indicated for the treatment of: Hypercalcemia of malignancy. ( 1.1 ) Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. ( 1.2 ) Limitations of Use : The safety and efficacy of Zoledronic Acid Injection has not been established f
                    label id
                    cd9bea2a-6045-452d-9ac5-e70d08e9e26f
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    b0baed267b743ab89f76c1b265ccd1538909b2ce7eb29a37202a58986bc74e1c
                    start
                    0
                    current approval status
                    not_reconciled
                    duplicate text group
                    dup-f9b77aa53b0ecd330241
                    extraction review status
                    automated_candidate_pending_source_review
                    generic names
                    1. ZOLEDRONIC ACID
                    id
                    ind-span-f28000395ee0e87da413
                    label id
                    cd9bea2a-6045-452d-9ac5-e70d08e9e26f
                    positive predicate support span
                    end
                    79
                    end exclusive
                    true
                    exact text
                    is a bisphosphonate indicated
                    label id
                    cd9bea2a-6045-452d-9ac5-e70d08e9e26f
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    b0baed267b743ab89f76c1b265ccd1538909b2ce7eb29a37202a58986bc74e1c
                    start
                    50
                    qualifier mentions
                    1. context exact
                      nts with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy.
                      kind
                      biomarker
                      polarity
                      not_inferred
                      span
                      end
                      232
                      end exclusive
                      true
                      exact text
                      metastases from solid tumors
                      label id
                      cd9bea2a-6045-452d-9ac5-e70d08e9e26f
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      b0baed267b743ab89f76c1b265ccd1538909b2ce7eb29a37202a58986bc74e1c
                      start
                      204
                    regulatory links
                      schema version
                      0.1.0
                      source batch sha256
                      a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
                      source defined aliases
                        source span
                        end
                        286
                        end exclusive
                        true
                        exact text
                        Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy.
                        label id
                        cd9bea2a-6045-452d-9ac5-e70d08e9e26f
                        offset unit
                        unicode_code_points
                        source array index
                        0
                        source field
                        indications_and_usage_exact
                        source text sha256
                        b0baed267b743ab89f76c1b265ccd1538909b2ce7eb29a37202a58986bc74e1c
                        start
                        139
                        source url
                        https://api.fda.gov/drug/label.json?search=id%3A%22cd9bea2a-6045-452d-9ac5-e70d08e9e26f%22
                        spl effective date
                        2025-03-11
                        spl set id
                        567578e6-cd2d-4339-b0f6-7a15444c0639
                        spl version
                        21
                        structured fields status
                        not_extracted_no_values_inferred_from_mentions
                        structured indication
                        age
                        Source null
                        approval pathway
                        Source null
                        biomarker and test
                        Source null
                        disease stage
                        Source null
                        limitations
                        Source null
                        line
                        Source null
                        prior therapy
                        Source null
                        regimen
                        Source null
                        tumor histology
                        Source null
                        use intent
                        tumor_directed_candidate
                        Passage 4 · unclassified context
                        application numbers
                        1. NDA203231
                        brand names
                        1. zoledronic acid
                        classification reasons
                        1. no_unambiguous_positive_indication_predicate
                        clinical review status
                        pending
                        content role
                        unclassified_context
                        context span
                        end
                        577
                        end exclusive
                        true
                        exact text
                        treatment of: Hypercalcemia of malignancy. ( 1.1 ) Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. ( 1.2 ) Limitations of Use : The safety and efficacy of Zoledronic Acid Injection has not been established for use in hyperparathyroidism or non-tumor-related hypercalcemia. 1.1 Hypercalcemia of Mali
                        label id
                        cd9bea2a-6045-452d-9ac5-e70d08e9e26f
                        offset unit
                        unicode_code_points
                        source array index
                        0
                        source field
                        indications_and_usage_exact
                        source text sha256
                        b0baed267b743ab89f76c1b265ccd1538909b2ce7eb29a37202a58986bc74e1c
                        start
                        87
                        current approval status
                        not_reconciled
                        duplicate text group
                        dup-98efbc2b38faeaffb7fb
                        extraction review status
                        automated_candidate_pending_source_review
                        generic names
                        1. ZOLEDRONIC ACID
                        id
                        ind-span-e4dce5a78d342ed04092
                        label id
                        cd9bea2a-6045-452d-9ac5-e70d08e9e26f
                        positive predicate support span
                        Source null
                        qualifier mentions
                          regulatory links
                            schema version
                            0.1.0
                            source batch sha256
                            a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
                            source defined aliases
                              source span
                              end
                              377
                              end exclusive
                              true
                              exact text
                              Prostate cancer should have progressed after treatment with at least one hormonal therapy.
                              label id
                              cd9bea2a-6045-452d-9ac5-e70d08e9e26f
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              b0baed267b743ab89f76c1b265ccd1538909b2ce7eb29a37202a58986bc74e1c
                              start
                              287
                              source url
                              https://api.fda.gov/drug/label.json?search=id%3A%22cd9bea2a-6045-452d-9ac5-e70d08e9e26f%22
                              spl effective date
                              2025-03-11
                              spl set id
                              567578e6-cd2d-4339-b0f6-7a15444c0639
                              spl version
                              21
                              structured fields status
                              not_extracted_no_values_inferred_from_mentions
                              structured indication
                              age
                              Source null
                              approval pathway
                              Source null
                              biomarker and test
                              Source null
                              disease stage
                              Source null
                              limitations
                              Source null
                              line
                              Source null
                              prior therapy
                              Source null
                              regimen
                              Source null
                              tumor histology
                              Source null
                              use intent
                              unclear
                              Passage 5 · limitation of use
                              application numbers
                              1. NDA203231
                              brand names
                              1. zoledronic acid
                              classification reasons
                              1. negative_or_not_established_clause
                              clinical review status
                              pending
                              content role
                              limitation_of_use
                              context span
                              end
                              751
                              end exclusive
                              true
                              exact text
                              ents with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. ( 1.2 ) Limitations of Use : The safety and efficacy of Zoledronic Acid Injection has not been established for use in hyperparathyroidism or non-tumor-related hypercalcemia. 1.1 Hypercalcemia of Malignancy Zoledronic Acid Injection is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cCa) of greater than or equal to 12 mg
                              label id
                              cd9bea2a-6045-452d-9ac5-e70d08e9e26f
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              b0baed267b743ab89f76c1b265ccd1538909b2ce7eb29a37202a58986bc74e1c
                              start
                              178
                              current approval status
                              not_reconciled
                              duplicate text group
                              dup-dcf8655b50bf05980c26
                              extraction review status
                              automated_candidate_pending_source_review
                              generic names
                              1. ZOLEDRONIC ACID
                              id
                              ind-span-1113ed80ce51abeb2bd1
                              label id
                              cd9bea2a-6045-452d-9ac5-e70d08e9e26f
                              positive predicate support span
                              Source null
                              qualifier mentions
                                regulatory links
                                  schema version
                                  0.1.0
                                  source batch sha256
                                  a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
                                  source defined aliases
                                    source span
                                    end
                                    551
                                    end exclusive
                                    true
                                    exact text
                                    ( 1.2 ) Limitations of Use : The safety and efficacy of Zoledronic Acid Injection has not been established for use in hyperparathyroidism or non-tumor-related hypercalcemia.
                                    label id
                                    cd9bea2a-6045-452d-9ac5-e70d08e9e26f
                                    offset unit
                                    unicode_code_points
                                    source array index
                                    0
                                    source field
                                    indications_and_usage_exact
                                    source text sha256
                                    b0baed267b743ab89f76c1b265ccd1538909b2ce7eb29a37202a58986bc74e1c
                                    start
                                    378
                                    source url
                                    https://api.fda.gov/drug/label.json?search=id%3A%22cd9bea2a-6045-452d-9ac5-e70d08e9e26f%22
                                    spl effective date
                                    2025-03-11
                                    spl set id
                                    567578e6-cd2d-4339-b0f6-7a15444c0639
                                    spl version
                                    21
                                    structured fields status
                                    not_extracted_no_values_inferred_from_mentions
                                    structured indication
                                    age
                                    Source null
                                    approval pathway
                                    Source null
                                    biomarker and test
                                    Source null
                                    disease stage
                                    Source null
                                    limitations
                                    Source null
                                    line
                                    Source null
                                    prior therapy
                                    Source null
                                    regimen
                                    Source null
                                    tumor histology
                                    Source null
                                    use intent
                                    not_applicable
                                    Passage 6 · positive indication candidate
                                    application numbers
                                    1. NDA203231
                                    brand names
                                    1. zoledronic acid
                                    classification reasons
                                    1. explicit_positive_indication_predicate
                                    2. supportive_or_complication_use_words
                                    clinical review status
                                    pending
                                    content role
                                    positive_indication_candidate
                                    context span
                                    end
                                    1053
                                    end exclusive
                                    true
                                    exact text
                                    ast one hormonal therapy. ( 1.2 ) Limitations of Use : The safety and efficacy of Zoledronic Acid Injection has not been established for use in hyperparathyroidism or non-tumor-related hypercalcemia. 1.1 Hypercalcemia of Malignancy Zoledronic Acid Injection is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cCa) of greater than or equal to 12 mg/dL [3 mmol/L] using the formula: cCa in mg/dL = Ca in mg/dL + 0.8 (4 g/dL – patient albumin [1g/dL]). 1.2 Multiple Myeloma and Bone Metastases of Solid Tumors Zoledronic Acid Injection is indicated for the treatment of patients with multiple myeloma and patients with documented bone metastases from s
                                    label id
                                    cd9bea2a-6045-452d-9ac5-e70d08e9e26f
                                    offset unit
                                    unicode_code_points
                                    source array index
                                    0
                                    source field
                                    indications_and_usage_exact
                                    source text sha256
                                    b0baed267b743ab89f76c1b265ccd1538909b2ce7eb29a37202a58986bc74e1c
                                    start
                                    352
                                    current approval status
                                    not_reconciled
                                    duplicate text group
                                    dup-0cf6475552a55115bf72
                                    extraction review status
                                    automated_candidate_pending_source_review
                                    generic names
                                    1. ZOLEDRONIC ACID
                                    id
                                    ind-span-1880293c1f3ca7820030
                                    label id
                                    cd9bea2a-6045-452d-9ac5-e70d08e9e26f
                                    positive predicate support span
                                    end
                                    622
                                    end exclusive
                                    true
                                    exact text
                                    is indicated
                                    label id
                                    cd9bea2a-6045-452d-9ac5-e70d08e9e26f
                                    offset unit
                                    unicode_code_points
                                    source array index
                                    0
                                    source field
                                    indications_and_usage_exact
                                    source text sha256
                                    b0baed267b743ab89f76c1b265ccd1538909b2ce7eb29a37202a58986bc74e1c
                                    start
                                    610
                                    qualifier mentions
                                      regulatory links
                                        schema version
                                        0.1.0
                                        source batch sha256
                                        a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
                                        source defined aliases
                                          source span
                                          end
                                          853
                                          end exclusive
                                          true
                                          exact text
                                          1.1 Hypercalcemia of Malignancy Zoledronic Acid Injection is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cCa) of greater than or equal to 12 mg/dL [3 mmol/L] using the formula: cCa in mg/dL = Ca in mg/dL + 0.8 (4 g/dL – patient albumin [1g/dL]).
                                          label id
                                          cd9bea2a-6045-452d-9ac5-e70d08e9e26f
                                          offset unit
                                          unicode_code_points
                                          source array index
                                          0
                                          source field
                                          indications_and_usage_exact
                                          source text sha256
                                          b0baed267b743ab89f76c1b265ccd1538909b2ce7eb29a37202a58986bc74e1c
                                          start
                                          552
                                          source url
                                          https://api.fda.gov/drug/label.json?search=id%3A%22cd9bea2a-6045-452d-9ac5-e70d08e9e26f%22
                                          spl effective date
                                          2025-03-11
                                          spl set id
                                          567578e6-cd2d-4339-b0f6-7a15444c0639
                                          spl version
                                          21
                                          structured fields status
                                          not_extracted_no_values_inferred_from_mentions
                                          structured indication
                                          age
                                          Source null
                                          approval pathway
                                          Source null
                                          biomarker and test
                                          Source null
                                          disease stage
                                          Source null
                                          limitations
                                          Source null
                                          line
                                          Source null
                                          prior therapy
                                          Source null
                                          regimen
                                          Source null
                                          tumor histology
                                          Source null
                                          use intent
                                          supportive_care_candidate
                                          Passage 7 · positive indication candidate
                                          application numbers
                                          1. NDA203231
                                          brand names
                                          1. zoledronic acid
                                          classification reasons
                                          1. explicit_positive_indication_predicate
                                          2. tumor_or_malignant_hematology_words_in_positive_statement
                                          clinical review status
                                          pending
                                          content role
                                          positive_indication_candidate
                                          context span
                                          end
                                          1318
                                          end exclusive
                                          true
                                          exact text
                                          mia of malignancy defined as an albumin-corrected calcium (cCa) of greater than or equal to 12 mg/dL [3 mmol/L] using the formula: cCa in mg/dL = Ca in mg/dL + 0.8 (4 g/dL – patient albumin [1g/dL]). 1.2 Multiple Myeloma and Bone Metastases of Solid Tumors Zoledronic Acid Injection is indicated for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. Limitations of Use The safety and efficacy of Zoledronic Acid Injection in the treatment of hypercalcemia as
                                          label id
                                          cd9bea2a-6045-452d-9ac5-e70d08e9e26f
                                          offset unit
                                          unicode_code_points
                                          source array index
                                          0
                                          source field
                                          indications_and_usage_exact
                                          source text sha256
                                          b0baed267b743ab89f76c1b265ccd1538909b2ce7eb29a37202a58986bc74e1c
                                          start
                                          654
                                          current approval status
                                          not_reconciled
                                          duplicate text group
                                          dup-9a3357ae87384e0da804
                                          extraction review status
                                          automated_candidate_pending_source_review
                                          generic names
                                          1. ZOLEDRONIC ACID
                                          id
                                          ind-span-573cb50908193be83a3b
                                          label id
                                          cd9bea2a-6045-452d-9ac5-e70d08e9e26f
                                          positive predicate support span
                                          end
                                          949
                                          end exclusive
                                          true
                                          exact text
                                          is indicated
                                          label id
                                          cd9bea2a-6045-452d-9ac5-e70d08e9e26f
                                          offset unit
                                          unicode_code_points
                                          source array index
                                          0
                                          source field
                                          indications_and_usage_exact
                                          source text sha256
                                          b0baed267b743ab89f76c1b265ccd1538909b2ce7eb29a37202a58986bc74e1c
                                          start
                                          937
                                          qualifier mentions
                                          1. context exact
                                            1.2 Multiple Myeloma and Bone Metastases of Solid Tumors Zoledronic Acid Injection is indicated for the treatment of patients with mu
                                            kind
                                            biomarker
                                            polarity
                                            not_inferred
                                            span
                                            end
                                            927
                                            end exclusive
                                            true
                                            exact text
                                            Metastases of Solid Tumors Zoledronic Acid
                                            label id
                                            cd9bea2a-6045-452d-9ac5-e70d08e9e26f
                                            offset unit
                                            unicode_code_points
                                            source array index
                                            0
                                            source field
                                            indications_and_usage_exact
                                            source text sha256
                                            b0baed267b743ab89f76c1b265ccd1538909b2ce7eb29a37202a58986bc74e1c
                                            start
                                            884
                                          2. context exact
                                            nts with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy.
                                            kind
                                            biomarker
                                            polarity
                                            not_inferred
                                            span
                                            end
                                            1064
                                            end exclusive
                                            true
                                            exact text
                                            metastases from solid tumors
                                            label id
                                            cd9bea2a-6045-452d-9ac5-e70d08e9e26f
                                            offset unit
                                            unicode_code_points
                                            source array index
                                            0
                                            source field
                                            indications_and_usage_exact
                                            source text sha256
                                            b0baed267b743ab89f76c1b265ccd1538909b2ce7eb29a37202a58986bc74e1c
                                            start
                                            1036
                                          regulatory links
                                            schema version
                                            0.1.0
                                            source batch sha256
                                            a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
                                            source defined aliases
                                              source span
                                              end
                                              1118
                                              end exclusive
                                              true
                                              exact text
                                              1.2 Multiple Myeloma and Bone Metastases of Solid Tumors Zoledronic Acid Injection is indicated for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy.
                                              label id
                                              cd9bea2a-6045-452d-9ac5-e70d08e9e26f
                                              offset unit
                                              unicode_code_points
                                              source array index
                                              0
                                              source field
                                              indications_and_usage_exact
                                              source text sha256
                                              b0baed267b743ab89f76c1b265ccd1538909b2ce7eb29a37202a58986bc74e1c
                                              start
                                              854
                                              source url
                                              https://api.fda.gov/drug/label.json?search=id%3A%22cd9bea2a-6045-452d-9ac5-e70d08e9e26f%22
                                              spl effective date
                                              2025-03-11
                                              spl set id
                                              567578e6-cd2d-4339-b0f6-7a15444c0639
                                              spl version
                                              21
                                              structured fields status
                                              not_extracted_no_values_inferred_from_mentions
                                              structured indication
                                              age
                                              Source null
                                              approval pathway
                                              Source null
                                              biomarker and test
                                              Source null
                                              disease stage
                                              Source null
                                              limitations
                                              Source null
                                              line
                                              Source null
                                              prior therapy
                                              Source null
                                              regimen
                                              Source null
                                              tumor histology
                                              Source null
                                              use intent
                                              tumor_directed_candidate
                                              Passage 8 · unclassified context
                                              application numbers
                                              1. NDA203231
                                              brand names
                                              1. zoledronic acid
                                              classification reasons
                                              1. no_unambiguous_positive_indication_predicate
                                              clinical review status
                                              pending
                                              content role
                                              unclassified_context
                                              context span
                                              end
                                              1409
                                              end exclusive
                                              true
                                              exact text
                                              ic Acid Injection is indicated for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. Limitations of Use The safety and efficacy of Zoledronic Acid Injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions have not been
                                              label id
                                              cd9bea2a-6045-452d-9ac5-e70d08e9e26f
                                              offset unit
                                              unicode_code_points
                                              source array index
                                              0
                                              source field
                                              indications_and_usage_exact
                                              source text sha256
                                              b0baed267b743ab89f76c1b265ccd1538909b2ce7eb29a37202a58986bc74e1c
                                              start
                                              919
                                              current approval status
                                              not_reconciled
                                              duplicate text group
                                              dup-98efbc2b38faeaffb7fb
                                              extraction review status
                                              automated_candidate_pending_source_review
                                              generic names
                                              1. ZOLEDRONIC ACID
                                              id
                                              ind-span-a3e611f65ccadcfa6b1b
                                              label id
                                              cd9bea2a-6045-452d-9ac5-e70d08e9e26f
                                              positive predicate support span
                                              Source null
                                              qualifier mentions
                                                regulatory links
                                                  schema version
                                                  0.1.0
                                                  source batch sha256
                                                  a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
                                                  source defined aliases
                                                    source span
                                                    end
                                                    1209
                                                    end exclusive
                                                    true
                                                    exact text
                                                    Prostate cancer should have progressed after treatment with at least one hormonal therapy.
                                                    label id
                                                    cd9bea2a-6045-452d-9ac5-e70d08e9e26f
                                                    offset unit
                                                    unicode_code_points
                                                    source array index
                                                    0
                                                    source field
                                                    indications_and_usage_exact
                                                    source text sha256
                                                    b0baed267b743ab89f76c1b265ccd1538909b2ce7eb29a37202a58986bc74e1c
                                                    start
                                                    1119
                                                    source url
                                                    https://api.fda.gov/drug/label.json?search=id%3A%22cd9bea2a-6045-452d-9ac5-e70d08e9e26f%22
                                                    spl effective date
                                                    2025-03-11
                                                    spl set id
                                                    567578e6-cd2d-4339-b0f6-7a15444c0639
                                                    spl version
                                                    21
                                                    structured fields status
                                                    not_extracted_no_values_inferred_from_mentions
                                                    structured indication
                                                    age
                                                    Source null
                                                    approval pathway
                                                    Source null
                                                    biomarker and test
                                                    Source null
                                                    disease stage
                                                    Source null
                                                    limitations
                                                    Source null
                                                    line
                                                    Source null
                                                    prior therapy
                                                    Source null
                                                    regimen
                                                    Source null
                                                    tumor histology
                                                    Source null
                                                    use intent
                                                    unclear
                                                    Passage 9 · limitation of use
                                                    application numbers
                                                    1. NDA203231
                                                    brand names
                                                    1. zoledronic acid
                                                    classification reasons
                                                    1. negative_or_not_established_clause
                                                    clinical review status
                                                    pending
                                                    content role
                                                    limitation_of_use
                                                    context span
                                                    end
                                                    1421
                                                    end exclusive
                                                    true
                                                    exact text
                                                    ents with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. Limitations of Use The safety and efficacy of Zoledronic Acid Injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions have not been established.
                                                    label id
                                                    cd9bea2a-6045-452d-9ac5-e70d08e9e26f
                                                    offset unit
                                                    unicode_code_points
                                                    source array index
                                                    0
                                                    source field
                                                    indications_and_usage_exact
                                                    source text sha256
                                                    b0baed267b743ab89f76c1b265ccd1538909b2ce7eb29a37202a58986bc74e1c
                                                    start
                                                    1010
                                                    current approval status
                                                    not_reconciled
                                                    duplicate text group
                                                    dup-3abdef2b1a2268460060
                                                    extraction review status
                                                    automated_candidate_pending_source_review
                                                    generic names
                                                    1. ZOLEDRONIC ACID
                                                    id
                                                    ind-span-fc4e67b154de7875eff1
                                                    label id
                                                    cd9bea2a-6045-452d-9ac5-e70d08e9e26f
                                                    positive predicate support span
                                                    Source null
                                                    qualifier mentions
                                                      regulatory links
                                                        schema version
                                                        0.1.0
                                                        source batch sha256
                                                        a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
                                                        source defined aliases
                                                          source span
                                                          end
                                                          1421
                                                          end exclusive
                                                          true
                                                          exact text
                                                          Limitations of Use The safety and efficacy of Zoledronic Acid Injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions have not been established.
                                                          label id
                                                          cd9bea2a-6045-452d-9ac5-e70d08e9e26f
                                                          offset unit
                                                          unicode_code_points
                                                          source array index
                                                          0
                                                          source field
                                                          indications_and_usage_exact
                                                          source text sha256
                                                          b0baed267b743ab89f76c1b265ccd1538909b2ce7eb29a37202a58986bc74e1c
                                                          start
                                                          1210
                                                          source url
                                                          https://api.fda.gov/drug/label.json?search=id%3A%22cd9bea2a-6045-452d-9ac5-e70d08e9e26f%22
                                                          spl effective date
                                                          2025-03-11
                                                          spl set id
                                                          567578e6-cd2d-4339-b0f6-7a15444c0639
                                                          spl version
                                                          21
                                                          structured fields status
                                                          not_extracted_no_values_inferred_from_mentions
                                                          structured indication
                                                          age
                                                          Source null
                                                          approval pathway
                                                          Source null
                                                          biomarker and test
                                                          Source null
                                                          disease stage
                                                          Source null
                                                          limitations
                                                          Source null
                                                          line
                                                          Source null
                                                          prior therapy
                                                          Source null
                                                          regimen
                                                          Source null
                                                          tumor histology
                                                          Source null
                                                          use intent
                                                          not_applicable

                                                          Preserved source evidence · Not medical advice