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LABELS · 4c442b87-1bbd-40e6-8c40-004f5f46e996

EDECRIN

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
2020-08-31
Captured
2026-09-09T23:37:47.659725+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. INDICATIONS AND USAGE EDECRIN is indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. 1. Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. 2. Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema. 3. Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome. 4. Intravenous SODIUM EDECRIN is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema, or when gastrointestinal absorption is impaired or oral medication is not practicable.
Full extracted label fields
application numbers
  1. NDA016092
boxed warning exact
    brand names
    1. EDECRIN
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1efe378e-fee1-4ae9-8ea5-0fe2265fe2d8
    generic names
    1. ETHACRYNIC ACID
    id
    4c442b87-1bbd-40e6-8c40-004f5f46e996
    indications and usage exact
    1. INDICATIONS AND USAGE EDECRIN is indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. 1. Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. 2. Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema. 3. Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome. 4. Intravenous SODIUM EDECRIN is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema, or when gastrointestinal absorption is impaired or oral medication is not practicable.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Bausch Health US, LLC
      matched search terms
      1. malignancy
      package ndcs
      1. 25010-215-15
      2. 25010-215-65
      3. 25010-210-27
      product ndcs
      1. 25010-215
      2. 25010-210
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 211509
        2. 617325
        3. 1251903
        4. 1251905
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00300.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
        300
        total
        830
        sha256
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        url
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        source url
        https://api.fda.gov/drug/label.json?search=id%3A%224c442b87-1bbd-40e6-8c40-004f5f46e996%22
        spl effective date
        2020-08-31
        spl effective time
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        spl set id
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        spl version
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        substance names
        1. ETHACRYNIC ACID
        uniis
        1. M5DP350VZV
        verification flags
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        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
          NDA016092
          payload
          all indexed label documents
          1. Appl No
            016092
            Application Docs Date
            2005-02-11 00:00:00
            Application Docs ID
            10870
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            42
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            016092
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            46
            Submission Status
            AP
            Submission Status Date
            2015-03-30 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          2. Appl No
            016092
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            42
            Submission Status
            AP
            Submission Status Date
            2005-02-09 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            016092
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            39
            Submission Status
            AP
            Submission Status Date
            2004-02-03 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            016092
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            38
            Submission Status
            AP
            Submission Status Date
            1998-08-14 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            016092
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            37
            Submission Status
            AP
            Submission Status Date
            1999-10-19 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            016092
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            36
            Submission Status
            AP
            Submission Status Date
            1997-11-03 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            016092
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            35
            Submission Status
            AP
            Submission Status Date
            1996-06-24 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            016092
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            34
            Submission Status
            AP
            Submission Status Date
            1995-03-24 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            016092
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            33
            Submission Status
            AP
            Submission Status Date
            1994-09-26 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            016092
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            32
            Submission Status
            AP
            Submission Status Date
            1991-08-07 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            016092
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            31
            Submission Status
            AP
            Submission Status Date
            1988-09-06 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          12. Appl No
            016092
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            30
            Submission Status
            AP
            Submission Status Date
            1988-08-15 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA016092
          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
          2015-03-30
          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
            016092
            Application Docs Date
            2005-02-11 00:00:00
            Application Docs ID
            10870
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            42
            Submission Type
            SUPPL
          official application record
          Appl No
          016092
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          BAUSCH
          openfda application present
          true
          products
          1. Active Ingredient
            ETHACRYNIC ACID
            Appl No
            016092
            Drug Name
            EDECRIN
            Form
            TABLET;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            25MG
            marketing status
            1. Prescription
          2. Active Ingredient
            ETHACRYNIC ACID
            Appl No
            016092
            Drug Name
            EDECRIN
            Form
            TABLET;ORAL
            Product No
            002
            Reference Drug
            0
            Reference Standard
            0
            Strength
            50MG
            marketing status
            1. Discontinued

        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. NDA016092
        brand names
        1. EDECRIN
        classification reasons
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        2. no_tumor_directed_keyword_in_positive_statement
        clinical review status
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        content role
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        exact text
        INDICATIONS AND USAGE EDECRIN is indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. 1. Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. 2. Short-term management of ascites due to malignancy, id
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              INDICATIONS AND USAGE EDECRIN is indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. 1.
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              use intent
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              Passage 2 · unclassified context
              application numbers
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              clinical review status
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              INDICATIONS AND USAGE EDECRIN is indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. 1. Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. 2. Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema. 3. Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or
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                    Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. 2.
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                    source url
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                    spl effective date
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                    regimen
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                    use intent
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                    Passage 3 · unclassified context
                    application numbers
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                    potential than those commonly employed is required. 1. Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. 2. Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema. 3. Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome. 4. Intravenous SODIUM EDECRIN is indicated when a rapid onset of
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                          Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema. 3.
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                          Passage 4 · unclassified context
                          application numbers
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                          with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. 2. Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema. 3. Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome. 4. Intravenous SODIUM EDECRIN is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema, or when gastrointestinal absorption is impaired or oral medication is not practicabl
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                              Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome. 4.
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                              spl effective date
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                              use intent
                              unclear
                              Passage 5 · positive indication candidate
                              application numbers
                              1. NDA016092
                              brand names
                              1. EDECRIN
                              classification reasons
                              1. explicit_positive_indication_predicate
                              2. no_tumor_directed_keyword_in_positive_statement
                              clinical review status
                              pending
                              content role
                              positive_indication_candidate
                              context span
                              end
                              730
                              end exclusive
                              true
                              exact text
                              cites due to malignancy, idiopathic edema, and lymphedema. 3. Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome. 4. Intravenous SODIUM EDECRIN is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema, or when gastrointestinal absorption is impaired or oral medication is not practicable.
                              label id
                              4c442b87-1bbd-40e6-8c40-004f5f46e996
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              26422c1f30b0476de162eada9bacf4c996f14f93888feda4199229bfa0498973
                              start
                              329
                              current approval status
                              not_reconciled
                              duplicate text group
                              dup-7ee8225a50f5d85a7c85
                              extraction review status
                              automated_candidate_pending_source_review
                              generic names
                              1. ETHACRYNIC ACID
                              id
                              ind-span-79890fe1dd7ecd6c089c
                              label id
                              4c442b87-1bbd-40e6-8c40-004f5f46e996
                              positive predicate support span
                              end
                              568
                              end exclusive
                              true
                              exact text
                              is indicated
                              label id
                              4c442b87-1bbd-40e6-8c40-004f5f46e996
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              26422c1f30b0476de162eada9bacf4c996f14f93888feda4199229bfa0498973
                              start
                              556
                              qualifier mentions
                                regulatory links
                                  schema version
                                  0.1.0
                                  source batch sha256
                                  bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
                                  source defined aliases
                                    source span
                                    end
                                    730
                                    end exclusive
                                    true
                                    exact text
                                    Intravenous SODIUM EDECRIN is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema, or when gastrointestinal absorption is impaired or oral medication is not practicable.
                                    label id
                                    4c442b87-1bbd-40e6-8c40-004f5f46e996
                                    offset unit
                                    unicode_code_points
                                    source array index
                                    0
                                    source field
                                    indications_and_usage_exact
                                    source text sha256
                                    26422c1f30b0476de162eada9bacf4c996f14f93888feda4199229bfa0498973
                                    start
                                    529
                                    source url
                                    https://api.fda.gov/drug/label.json?search=id%3A%224c442b87-1bbd-40e6-8c40-004f5f46e996%22
                                    spl effective date
                                    2020-08-31
                                    spl set id
                                    1efe378e-fee1-4ae9-8ea5-0fe2265fe2d8
                                    spl version
                                    10
                                    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
                                    non_oncology_or_unclear_candidate

                                    Preserved source evidence · Not medical advice