NDC 59923-701

EPIRUBICIN HYDROCHLORIDE

Epirubicin Hydrochloride

EPIRUBICIN HYDROCHLORIDE is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Areva Pharmaceuticals,inc.. The primary component is Epirubicin Hydrochloride.

Product ID59923-701_7d4f6cb1-c0de-9fd1-e053-2991aa0a9988
NDC59923-701
Product TypeHuman Prescription Drug
Proprietary NameEPIRUBICIN HYDROCHLORIDE
Generic NameEpirubicin Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2014-05-19
Marketing CategoryANDA / ANDA
Application NumberANDA065361
Labeler NameAreva Pharmaceuticals,Inc.
Substance NameEPIRUBICIN HYDROCHLORIDE
Active Ingredient Strength2 mg/mL
Pharm ClassesAnthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [CS],Topoisomerase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 59923-701-00

1 VIAL in 1 CARTON (59923-701-00) > 100 mL in 1 VIAL
Marketing Start Date2014-05-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59923-701-00 [59923070100]

EPIRUBICIN HYDROCHLORIDE INJECTION
Marketing CategoryANDA
Application NumberANDA065361
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-05-19

NDC 59923-701-25 [59923070125]

EPIRUBICIN HYDROCHLORIDE INJECTION
Marketing CategoryANDA
Application NumberANDA065361
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-05-19

Drug Details

Active Ingredients

IngredientStrength
EPIRUBICIN HYDROCHLORIDE2 mg/mL

OpenFDA Data

SPL SET ID:ab115cc4-43cd-4a59-aa01-89e356ce3a08
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1732182
  • 1732186
    • UPC Code
  • 0359923701250
  • 0359923701007

    • Pharmacological Class

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

    NDC Crossover Matching brand name "EPIRUBICIN HYDROCHLORIDE" or generic name "Epirubicin Hydrochloride"

    NDCBrand NameGeneric Name
    0115-1675Epirubicin HydrochlorideEpirubicin Hydrochloride
    0143-9202Epirubicin HydrochlorideEpirubicin Hydrochloride
    0143-9203Epirubicin HydrochlorideEpirubicin Hydrochloride
    25021-203Epirubicin Hydrochlorideepirubicin hydrochloride
    45963-608Epirubicin HydrochlorideEpirubicin Hydrochloride
    59923-701EPIRUBICIN HYDROCHLORIDEEPIRUBICIN HYDROCHLORIDE
    63323-151Epirubicin Hydrochlorideepirubicin hydrochloride
    66758-042Epirubicin HydrochlorideEpirubicin Hydrochloride
    0009-5091Ellenceepirubicin hydrochloride
    0009-5093Ellenceepirubicin hydrochloride
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