NDC 0703-5233

daunorubicin hydrochloride

Daunorubicin Hydrochloride

daunorubicin hydrochloride is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Teva Parenteral Medicines, Inc.. The primary component is Daunorubicin Hydrochloride.

Product ID0703-5233_78928bf7-c736-4d9a-8137-a0a5c0653540
NDC0703-5233
Product TypeHuman Prescription Drug
Proprietary Namedaunorubicin hydrochloride
Generic NameDaunorubicin Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2004-04-01
Marketing CategoryANDA / ANDA
Application NumberANDA065035
Labeler NameTeva Parenteral Medicines, Inc.
Substance NameDAUNORUBICIN HYDROCHLORIDE
Active Ingredient Strength5 mg/mL
Pharm ClassesAnthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [CS],Topoisomerase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0703-5233-13

10 VIAL, SINGLE-DOSE in 1 CARTON (0703-5233-13) > 4 mL in 1 VIAL, SINGLE-DOSE (0703-5233-11)
Marketing Start Date2004-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0703-5233-13 [00703523313]

daunorubicin hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA065035
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2004-04-01

NDC 0703-5233-93 [00703523393]

daunorubicin hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA065035
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2004-04-01
Marketing End Date2016-06-30

NDC 0703-5233-91 [00703523391]

daunorubicin hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA065035
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2004-04-01
Marketing End Date2016-06-30

NDC 0703-5233-11 [00703523311]

daunorubicin hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA065035
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2004-04-01

Drug Details

Active Ingredients

IngredientStrength
DAUNORUBICIN HYDROCHLORIDE5 mg/mL

OpenFDA Data

SPL SET ID:29fe455e-f177-4b0e-99fb-60a53016db72
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 309650
  • Pharmacological Class

    • Anthracycline Topoisomerase Inhibitor [EPC]
    • Anthracyclines [CS]
    • Topoisomerase Inhibitors [MoA]
    • Anthracycline Topoisomerase Inhibitor [EPC]
    • Anthracyclines [CS]
    • Topoisomerase Inhibitors [MoA]

    NDC Crossover Matching brand name "daunorubicin hydrochloride" or generic name "Daunorubicin Hydrochloride"

    NDCBrand NameGeneric Name
    0143-9550Daunorubicin HydrochlorideDaunorubicin Hydrochloride
    0143-9551Daunorubicin HydrochlorideDaunorubicin Hydrochloride
    0703-5233daunorubicin hydrochloridedaunorubicin hydrochloride
    42658-019Daunorubicin Hydrochloridedaunorubicin hydrochloride
    42658-021Daunorubicin Hydrochloridedaunorubicin hydrochloride

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.