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LABELS · f07e5c60-6ea3-4323-a9fe-b35264e667b6

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
2021-09-20
Captured
2026-09-09T23:38:02.384588+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=deb89be7-f40e-4fd4-a2cb-96634b45da84
    generic names
    1. ZOLEDRONIC ACID
    id
    f07e5c60-6ea3-4323-a9fe-b35264e667b6
    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. 25021-826-67
      product ndcs
      1. 25021-826
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Warnings and Precautions, Embryo-Fetal Toxicity ( 5.10 ) 10/2020
      record type
      complete_spl_indications_section_candidate
      routes
      1. INTRAVENOUS
      rxcuis
      1. 1114085
      source batch
      file
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      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
      700
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      830
      sha256
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      url
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      source url
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      spl effective date
      2021-09-20
      spl effective time
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      spl set id
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      spl version
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      substance names
      1. ZOLEDRONIC ACID
      uniis
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      verification flags
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      Drugs@FDA application source records
      1. application number
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        payload
        all indexed label documents
        1. Appl No
          203231
          Application Docs Date
          2013-08-06 00:00:00
          Application Docs ID
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          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          203231
          Application Docs Date
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          Application Docs ID
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          Application Docs Title
          0
          Application Docs Type ID
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          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
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          Submission No
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          Submission Status
          AP
          Submission Status Date
          2020-10-27 00:00:00
          Submission Type
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          Submissions Public Notes
        3. Appl No
          203231
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
          16
          Submission Status
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          Submission Status Date
          2020-10-27 00:00:00
          Submission Type
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          Submissions Public Notes
        4. Appl No
          203231
          Review Priority
          STANDARD
          Submission Class Code ID
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          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
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          Submission Type
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          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
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          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
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        approval interpretation
        Application linkage and approved submission are not indication-level current approval verification
        current indication status
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        has approved submission record
        true
        latest approved submission date
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        latest label selection rule
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        latest posted label documents
        1. Appl No
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          Application Docs Date
          2022-04-06 00:00:00
          Application Docs ID
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          Application Docs Title
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          Application Docs Type ID
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          Submission No
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          Submission Type
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        official application record
        Appl No
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        Appl Public Notes
        Appl Type
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        Sponsor Name
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        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
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      brand names
      1. zoledronic acid
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      content role
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      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
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      is a bisphosphonate indicated
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            1 INDICATIONS AND USAGE Zoledronic Acid Injection is a bisphosphonate indicated for the treatment of: Hypercalcemia of malignancy.
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            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
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                  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
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                      Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy.
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                                                        Preserved source evidence · Not medical advice