NDC 66758-042

Epirubicin Hydrochloride

Epirubicin Hydrochloride

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

Product ID66758-042_516afd6b-38ec-4819-9bb1-37606c0d6739
NDC66758-042
Product TypeHuman Prescription Drug
Proprietary NameEpirubicin Hydrochloride
Generic NameEpirubicin Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2009-12-22
Marketing CategoryANDA / ANDA
Application NumberANDA065339
Labeler NameSandoz Inc
Substance NameEPIRUBICIN HYDROCHLORIDE
Active Ingredient Strength2 mg/mL
Pharm ClassesAnthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [CS],Topoisomerase Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 66758-042-01

1 VIAL, SINGLE-USE in 1 CARTON (66758-042-01) > 25 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2009-12-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66758-042-01 [66758004201]

Epirubicin Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA065339
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-12-22
Inactivation Date2019-11-27

NDC 66758-042-02 [66758004202]

Epirubicin Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA065339
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-12-22
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
EPIRUBICIN HYDROCHLORIDE2 mg/mL

OpenFDA Data

SPL SET ID:140e953d-d180-4097-80da-b3ecb50465d5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1732182
  • 1732186

    • 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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