NDC 0143-9202

Epirubicin Hydrochloride

Epirubicin Hydrochloride

Epirubicin Hydrochloride is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Hikma Pharmaceuticals Usa Inc.. The primary component is Epirubicin Hydrochloride.

Product ID0143-9202_a854383a-1d91-456c-baae-2e4011faf1a5
NDC0143-9202
Product TypeHuman Prescription Drug
Proprietary NameEpirubicin Hydrochloride
Generic NameEpirubicin Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2007-08-07
Marketing CategoryANDA / ANDA
Application NumberANDA065289
Labeler NameHikma Pharmaceuticals USA 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 0143-9202-01

1 VIAL in 1 BOX (0143-9202-01) > 25 mL in 1 VIAL
Marketing Start Date2007-08-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0143-9202-01 [00143920201]

Epirubicin Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA065289
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2007-08-07

Drug Details

Active Ingredients

IngredientStrength
EPIRUBICIN HYDROCHLORIDE2 mg/mL

OpenFDA Data

SPL SET ID:a24ff5f2-0a9a-4222-9135-1d4094ddd2e0
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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.