NDC 45963-608

Epirubicin Hydrochloride

Epirubicin Hydrochloride

Epirubicin Hydrochloride is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Epirubicin Hydrochloride.

Product ID45963-608_3febb20b-3fa7-4b00-98d7-3b249ab017c1
NDC45963-608
Product TypeHuman Prescription Drug
Proprietary NameEpirubicin Hydrochloride
Generic NameEpirubicin Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2011-11-28
Marketing CategoryANDA / ANDA
Application NumberANDA065445
Labeler NameActavis Pharma, 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 45963-608-68

1 VIAL, SINGLE-USE in 1 CARTON (45963-608-68) > 25 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2011-11-28
Marketing End Date2021-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45963-608-68 [45963060868]

Epirubicin Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA065445
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-11-28

NDC 45963-608-60 [45963060860]

Epirubicin Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA065445
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-11-28
Marketing End Date2020-10-31

Drug Details

Active Ingredients

IngredientStrength
EPIRUBICIN HYDROCHLORIDE2 mg/mL

OpenFDA Data

SPL SET ID:d42a4313-63b8-47d5-a346-817998b5bf95
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1732182
  • 1732186
    • UPC Code
  • 0345963608680

    • 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 "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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