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LABELS · 451aa56d-e2e5-402f-843a-cddb5b3d37dd

Proglycem

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
2024-07-19
Captured
2026-09-09T23:37:44.904352+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. INDICATIONS AND USAGE PROGLYCEM is indicated for the management of hypoglycemia due to hyperinsulinism associated with the following conditions: Adults: Inoperable islet cell adenoma or carcinoma, or extrapancreatic malignancy. Infants and children: Leucine sensitivity, islet cell hyperplasia, nesidioblastosis, extrapancreatic malignancy, islet cell adenoma, or adenomatosis. PROGLYCEM may be used preoperatively as a temporary measure, and postoperatively, if hypoglycemia persists. PROGLYCEM should be used only after a diagnosis of hypoglycemia due to one of the above conditions has been definitely established. When other specific medical therapy or surgical management either has been unsuccessful or is not feasible, treatment with PROGLYCEM should be considered.
Full extracted label fields
application numbers
  1. NDA017453
boxed warning exact
    brand names
    1. Proglycem
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b16c7832-2fd9-49af-b923-1dc0d91fd6e2
    generic names
    1. DIAZOXIDE
    id
    451aa56d-e2e5-402f-843a-cddb5b3d37dd
    indications and usage exact
    1. INDICATIONS AND USAGE PROGLYCEM is indicated for the management of hypoglycemia due to hyperinsulinism associated with the following conditions: Adults: Inoperable islet cell adenoma or carcinoma, or extrapancreatic malignancy. Infants and children: Leucine sensitivity, islet cell hyperplasia, nesidioblastosis, extrapancreatic malignancy, islet cell adenoma, or adenomatosis. PROGLYCEM may be used preoperatively as a temporary measure, and postoperatively, if hypoglycemia persists. PROGLYCEM should be used only after a diagnosis of hypoglycemia due to one of the above conditions has been definitely established. When other specific medical therapy or surgical management either has been unsuccessful or is not feasible, treatment with PROGLYCEM should be considered.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Teva Pharmaceuticals USA, Inc.
      matched search terms
      1. carcinoma
      2. malignancy
      package ndcs
      1. 0575-6200-30
      product ndcs
      1. 0575-6200
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 197593
        2. 207634
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00200.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
        200
        total
        830
        sha256
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        url
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        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22451aa56d-e2e5-402f-843a-cddb5b3d37dd%22
        spl effective date
        2024-07-19
        spl effective time
        20240719
        spl set id
        b16c7832-2fd9-49af-b923-1dc0d91fd6e2
        spl version
        15
        substance names
        1. DIAZOXIDE
        uniis
        1. O5CB12L4FN
        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
        4. fda_label_posted_after_spl_effective_date_requires_version_review
        Drugs@FDA application source records
        1. application number
          NDA017453
          payload
          all indexed label documents
          1. Appl No
            017453
            Application Docs Date
            2009-01-02 00:00:00
            Application Docs ID
            33273
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            14
            Submission Type
            SUPPL
          2. Appl No
            017453
            Application Docs Date
            2015-09-21 00:00:00
            Application Docs ID
            33274
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            20
            Submission Type
            SUPPL
          3. Appl No
            017453
            Application Docs Date
            2022-12-27 00:00:00
            Application Docs ID
            73048
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            23
            Submission Type
            SUPPL
          4. Appl No
            017453
            Application Docs Date
            2024-07-22 00:00:00
            Application Docs ID
            79146
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            24
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            017453
            Review Priority
            PRIORITY
            Submission Class Code ID
            12
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            1976-05-28 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            017453
            Review Priority
            Submission Class Code ID
            3
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            1979-09-07 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            017453
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            2
            Submission Status
            AP
            Submission Status Date
            1980-07-09 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            017453
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            3
            Submission Status
            AP
            Submission Status Date
            1981-06-23 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            017453
            Review Priority
            Submission Class Code ID
            3
            Submission No
            4
            Submission Status
            AP
            Submission Status Date
            1982-12-14 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            017453
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            5
            Submission Status
            AP
            Submission Status Date
            1984-12-04 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            017453
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            6
            Submission Status
            AP
            Submission Status Date
            1987-02-24 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            017453
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            7
            Submission Status
            AP
            Submission Status Date
            1987-05-14 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            017453
            Review Priority
            Submission Class Code ID
            3
            Submission No
            8
            Submission Status
            AP
            Submission Status Date
            1989-07-28 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            017453
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            10
            Submission Status
            AP
            Submission Status Date
            2004-01-21 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            017453
            Review Priority
            N/A
            Submission Class Code ID
            4
            Submission No
            14
            Submission Status
            AP
            Submission Status Date
            2008-12-17 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          12. Appl No
            017453
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            16
            Submission Status
            AP
            Submission Status Date
            2013-11-21 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA017453
          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
          2024-07-18
          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
            017453
            Application Docs Date
            2024-07-22 00:00:00
            Application Docs ID
            79146
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            24
            Submission Type
            SUPPL
          official application record
          Appl No
          017453
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          TEVA BRANDED PHARM
          openfda application present
          true
          products
          1. Active Ingredient
            DIAZOXIDE
            Appl No
            017453
            Drug Name
            PROGLYCEM
            Form
            SUSPENSION;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            50MG/ML
            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. NDA017453
        brand names
        1. Proglycem
        classification reasons
        1. explicit_positive_indication_predicate
        2. tumor_or_malignant_hematology_words_in_positive_statement
        clinical review status
        pending
        content role
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        context span
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        427
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        true
        exact text
        INDICATIONS AND USAGE PROGLYCEM is indicated for the management of hypoglycemia due to hyperinsulinism associated with the following conditions: Adults: Inoperable islet cell adenoma or carcinoma, or extrapancreatic malignancy. Infants and children: Leucine sensitivity, islet cell hyperplasia, nesidioblastosis, extrapancreatic malignancy, islet cell adenoma, or adenomatosis. PROGLYCEM may be used preoperatively as a tempora
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        exact text
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        start
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        qualifier mentions
        1. context exact
          o hyperinsulinism associated with the following conditions: Adults: Inoperable islet cell adenoma or carcinoma, or extrapancre
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          Adults
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        regulatory links
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          source defined aliases
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            end exclusive
            true
            exact text
            INDICATIONS AND USAGE PROGLYCEM is indicated for the management of hypoglycemia due to hyperinsulinism associated with the following conditions: Adults: Inoperable islet cell adenoma or carcinoma, or extrapancreatic malignancy.
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            source url
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            spl effective date
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            spl set id
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            structured fields status
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            structured indication
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            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 2 · unclassified context
            application numbers
            1. NDA017453
            brand names
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            classification reasons
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            clinical review status
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            content role
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            context span
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            577
            end exclusive
            true
            exact text
            CEM is indicated for the management of hypoglycemia due to hyperinsulinism associated with the following conditions: Adults: Inoperable islet cell adenoma or carcinoma, or extrapancreatic malignancy. Infants and children: Leucine sensitivity, islet cell hyperplasia, nesidioblastosis, extrapancreatic malignancy, islet cell adenoma, or adenomatosis. PROGLYCEM may be used preoperatively as a temporary measure, and postoperatively, if hypoglycemia persists. PROGLYCEM should be used only after a diagnosis of hypoglycemia due to one of the above con
            label id
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            offset unit
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            generic names
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            label id
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            positive predicate support span
            Source null
            qualifier mentions
            1. context exact
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                exact text
                Infants and children: Leucine sensitivity, islet cell hyperplasia, nesidioblastosis, extrapancreatic malignancy, islet cell adenoma, or adenomatosis.
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                source url
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                spl effective date
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                limitations
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                line
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                prior therapy
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                regimen
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                tumor histology
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                use intent
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                Passage 3 · unclassified context
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                exact text
                noma or carcinoma, or extrapancreatic malignancy. Infants and children: Leucine sensitivity, islet cell hyperplasia, nesidioblastosis, extrapancreatic malignancy, islet cell adenoma, or adenomatosis. PROGLYCEM may be used preoperatively as a temporary measure, and postoperatively, if hypoglycemia persists. PROGLYCEM should be used only after a diagnosis of hypoglycemia due to one of the above conditions has been definitely established. When other specific medical therapy or surgical management either h
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                      exact text
                      PROGLYCEM may be used preoperatively as a temporary measure, and postoperatively, if hypoglycemia persists.
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                      source url
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                      Source null
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                      use intent
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                      Passage 4 · unclassified context
                      application numbers
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                      exact text
                      rplasia, nesidioblastosis, extrapancreatic malignancy, islet cell adenoma, or adenomatosis. PROGLYCEM may be used preoperatively as a temporary measure, and postoperatively, if hypoglycemia persists. PROGLYCEM should be used only after a diagnosis of hypoglycemia due to one of the above conditions has been definitely established. When other specific medical therapy or surgical management either has been unsuccessful or is not feasible, treatment with PROGLYCEM should be considered.
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                      positive predicate support span
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                            617
                            end exclusive
                            true
                            exact text
                            PROGLYCEM should be used only after a diagnosis of hypoglycemia due to one of the above conditions has been definitely established.
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                            offset unit
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                            source text sha256
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                            486
                            source url
                            https://api.fda.gov/drug/label.json?search=id%3A%22451aa56d-e2e5-402f-843a-cddb5b3d37dd%22
                            spl effective date
                            2024-07-19
                            spl set id
                            b16c7832-2fd9-49af-b923-1dc0d91fd6e2
                            spl version
                            15
                            structured fields status
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                            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 · unclassified context
                            application numbers
                            1. NDA017453
                            brand names
                            1. Proglycem
                            classification reasons
                            1. no_unambiguous_positive_indication_predicate
                            clinical review status
                            pending
                            content role
                            unclassified_context
                            context span
                            end
                            772
                            end exclusive
                            true
                            exact text
                            a temporary measure, and postoperatively, if hypoglycemia persists. PROGLYCEM should be used only after a diagnosis of hypoglycemia due to one of the above conditions has been definitely established. When other specific medical therapy or surgical management either has been unsuccessful or is not feasible, treatment with PROGLYCEM should be considered.
                            label id
                            451aa56d-e2e5-402f-843a-cddb5b3d37dd
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                            unicode_code_points
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                            0
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                            source text sha256
                            028ac655579df194ac71ad517609e927e4612d4b5f53ca84e09c4bf249005390
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                            418
                            current approval status
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                            duplicate text group
                            dup-4bc406a233b9b2c9b4f5
                            extraction review status
                            automated_candidate_pending_source_review
                            generic names
                            1. DIAZOXIDE
                            id
                            ind-span-213a431387da98b9b4b9
                            label id
                            451aa56d-e2e5-402f-843a-cddb5b3d37dd
                            positive predicate support span
                            Source null
                            qualifier mentions
                              regulatory links
                                schema version
                                0.1.0
                                source batch sha256
                                d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
                                source defined aliases
                                  source span
                                  end
                                  772
                                  end exclusive
                                  true
                                  exact text
                                  When other specific medical therapy or surgical management either has been unsuccessful or is not feasible, treatment with PROGLYCEM should be considered.
                                  label id
                                  451aa56d-e2e5-402f-843a-cddb5b3d37dd
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  028ac655579df194ac71ad517609e927e4612d4b5f53ca84e09c4bf249005390
                                  start
                                  618
                                  source url
                                  https://api.fda.gov/drug/label.json?search=id%3A%22451aa56d-e2e5-402f-843a-cddb5b3d37dd%22
                                  spl effective date
                                  2024-07-19
                                  spl set id
                                  b16c7832-2fd9-49af-b923-1dc0d91fd6e2
                                  spl version
                                  15
                                  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

                                  Preserved source evidence · Not medical advice