NDC 0143-9551

Daunorubicin Hydrochloride

Daunorubicin Hydrochloride

Daunorubicin Hydrochloride is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by West-ward Pharmaceuticals Corp. The primary component is Daunorubicin Hydrochloride.

Product ID0143-9551_0c0fd678-961a-4d4f-9c26-82ae9acc86e9
NDC0143-9551
Product TypeHuman Prescription Drug
Proprietary NameDaunorubicin Hydrochloride
Generic NameDaunorubicin Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-01-02
Marketing CategoryNDA / NDA
Application NumberNDA050731
Labeler NameWest-Ward Pharmaceuticals Corp
Substance NameDAUNORUBICIN HYDROCHLORIDE
Active Ingredient Strength5 mg/mL
Pharm ClassesAnthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [CS],Topoisomerase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0143-9551-10

10 VIAL in 1 BOX (0143-9551-10) > 4 mL in 1 VIAL (0143-9551-01)
Marketing Start Date2018-01-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0143-9551-01 [00143955101]

Daunorubicin Hydrochloride INJECTION
Marketing CategoryNDA
Application NumberNDA050731
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-01-02

NDC 0143-9551-10 [00143955110]

Daunorubicin Hydrochloride INJECTION
Marketing CategoryNDA
Application NumberNDA050731
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-01-02

Drug Details

Active Ingredients

IngredientStrength
DAUNORUBICIN HYDROCHLORIDE5 mg/mL

OpenFDA Data

SPL SET ID:227784a8-ce68-4dd4-8ac5-a65265969677
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 309650
  • 2002002
  • Pharmacological Class

    • 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

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