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LABELS · d77dc365-6db8-4bdc-81fc-7ac80bcc7699

Daunorubicin Hydrochloride

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
2024-02-15
Captured
2026-09-09T23:38:02.384588+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNINGS 1.Daunorubicin Hydrochloride Injection must be given into a rapidly flowing intravenous infusion. It must never be given by the intramuscular or subcutaneous route. Severe local tissue necrosis will occur if there is extravasation during administration. 2.Myocardial toxicity manifested in its most severe form by potentially fatal congestive heart failure may occur either during therapy or months to years after termination of therapy. The incidence of myocardial toxicity increases after a total cumulative dose exceeding 400 to 550 mg/m 2 in adults, 300 mg/m 2 in children more than 2 years of age, or 10 mg/kg in children less than 2 years of age. 3.Severe myelosuppression occurs when used in therapeutic doses; this may lead to infection or hemorrhage. 4.It is recommended that daunorubicin hydrochloride be administered only by physicians who are experienced in leukemia chemotherapy and in facilities with laboratory and supportive resources adequate to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity. The physician and institution must be capable of responding rapidly and completely to severe hemorrhagic conditions and/or overwhelming infection. 5.Dosage should be reduced in patients with impaired hepatic or renal function.

Indications and usage: exact source text

  1. INDICATIONS AND USAGE Daunorubicin hydrochloride in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.
Full extracted label fields
application numbers
  1. NDA050731
boxed warning exact
  1. WARNINGS 1.Daunorubicin Hydrochloride Injection must be given into a rapidly flowing intravenous infusion. It must never be given by the intramuscular or subcutaneous route. Severe local tissue necrosis will occur if there is extravasation during administration. 2.Myocardial toxicity manifested in its most severe form by potentially fatal congestive heart failure may occur either during therapy or months to years after termination of therapy. The incidence of myocardial toxicity increases after a total cumulative dose exceeding 400 to 550 mg/m 2 in adults, 300 mg/m 2 in children more than 2 years of age, or 10 mg/kg in children less than 2 years of age. 3.Severe myelosuppression occurs when used in therapeutic doses; this may lead to infection or hemorrhage. 4.It is recommended that daunorubicin hydrochloride be administered only by physicians who are experienced in leukemia chemotherapy and in facilities with laboratory and supportive resources adequate to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity. The physician and institution must be capable of responding rapidly and completely to severe hemorrhagic conditions and/or overwhelming infection. 5.Dosage should be reduced in patients with impaired hepatic or renal function.
brand names
  1. Daunorubicin Hydrochloride
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=227784a8-ce68-4dd4-8ac5-a65265969677
generic names
  1. DAUNORUBICIN HYDROCHLORIDE
id
d77dc365-6db8-4bdc-81fc-7ac80bcc7699
indications and usage exact
  1. INDICATIONS AND USAGE Daunorubicin hydrochloride in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Hikma Pharmaceuticals USA Inc.
    matched search terms
    1. leukemia
    package ndcs
    1. 0143-9551-01
    2. 0143-9551-10
    3. 0143-9550-01
    product ndcs
    1. 0143-9550
    2. 0143-9551
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
      record type
      complete_spl_indications_section_candidate
      routes
      1. INTRAVENOUS
      rxcuis
      1. 309650
      2. 2002002
      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
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      sha256
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      url
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      source url
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      spl effective date
      2024-02-15
      spl effective time
      20240215
      spl set id
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      spl version
      6
      substance names
      1. DAUNORUBICIN HYDROCHLORIDE
      uniis
      1. UD984I04LZ
      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
        NDA050731
        payload
        all indexed label documents
          all submission records
          1. Appl No
            050731
            Review Priority
            STANDARD
            Submission Class Code ID
            12
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            1998-01-30 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            050731
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            1999-04-29 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            050731
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            2
            Submission Status
            AP
            Submission Status Date
            2001-03-02 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            050731
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            3
            Submission Status
            AP
            Submission Status Date
            2002-06-12 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            050731
            Review Priority
            STANDARD
            Submission Class Code ID
            19
            Submission No
            8
            Submission Status
            AP
            Submission Status Date
            2018-09-27 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA050731
          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
          2018-09-27
          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
            official application record
            Appl No
            050731
            Appl Public Notes
            Appl Type
            NDA
            Sponsor Name
            HIKMA
            openfda application present
            true
            products
            1. Active Ingredient
              DAUNORUBICIN HYDROCHLORIDE
              Appl No
              050731
              Drug Name
              DAUNORUBICIN HYDROCHLORIDE
              Form
              INJECTABLE;INJECTION
              Product No
              001
              Reference Drug
              1
              Reference Standard
              1
              Strength
              EQ 5MG BASE/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. NDA050731
          brand names
          1. Daunorubicin Hydrochloride
          classification reasons
          1. explicit_positive_indication_predicate
          2. tumor_or_malignant_hematology_words_in_positive_statement
          clinical review status
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          content role
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          298
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          true
          exact text
          INDICATIONS AND USAGE Daunorubicin hydrochloride in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.
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          generic names
          1. DAUNORUBICIN HYDROCHLORIDE
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          qualifier mentions
          1. context exact
            lymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia o
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            not_inferred
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            end exclusive
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            exact text
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          3. context exact
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          4. context exact
            INDICATIONS AND USAGE Daunorubicin hydrochloride in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children a
            kind
            regimen
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            span
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            true
            exact text
            in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for rem
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          regulatory links
            schema version
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            source defined aliases
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              exact text
              INDICATIONS AND USAGE Daunorubicin hydrochloride in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.
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              start
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              source url
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              spl effective date
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              spl set id
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              spl version
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              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

              Preserved source evidence · Not medical advice