NDC 0143-9203

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 ID: 0143-9203_a854383a-1d91-456c-baae-2e4011faf1a5
• NDC: 0143-9203
• Product Type: Human Prescription Drug
• Proprietary Name: Epirubicin Hydrochloride
• Generic Name: Epirubicin Hydrochloride
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2007-08-07
• Marketing Category: ANDA / ANDA
• Application Number: ANDA065289
• Labeler Name: Hikma Pharmaceuticals USA Inc.
• Substance Name: EPIRUBICIN HYDROCHLORIDE
• Active Ingredient Strength: 2 mg/mL
• Pharm Classes: Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [CS],Topoisomerase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0143-9203-01

1 VIAL in 1 BOX (0143-9203-01) > 50 mL in 1 VIAL

• Marketing Start Date: 2007-08-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0143-9203-01 [00143920301]

Epirubicin Hydrochloride INJECTION

• Marketing Category: ANDA
• Application Number: ANDA065289
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2007-08-07

Drug Details

Active Ingredients

Ingredient	Strength
EPIRUBICIN HYDROCHLORIDE	2 mg/mL

OpenFDA Data

• SPL SET ID: a24ff5f2-0a9a-4222-9135-1d4094ddd2e0
• Manufacturer:
  • West-Ward Pharmaceuticals Corp
• UNII:
  • 22966TX7J5
• 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"

NDC	Brand Name	Generic Name
0115-1675	Epirubicin Hydrochloride	Epirubicin Hydrochloride
0143-9202	Epirubicin Hydrochloride	Epirubicin Hydrochloride
0143-9203	Epirubicin Hydrochloride	Epirubicin Hydrochloride
25021-203	Epirubicin Hydrochloride	epirubicin hydrochloride
45963-608	Epirubicin Hydrochloride	Epirubicin Hydrochloride
59923-701	EPIRUBICIN HYDROCHLORIDE	EPIRUBICIN HYDROCHLORIDE
63323-151	Epirubicin Hydrochloride	epirubicin hydrochloride
66758-042	Epirubicin Hydrochloride	Epirubicin Hydrochloride
0009-5091	Ellence	epirubicin hydrochloride
0009-5093	Ellence	epirubicin hydrochloride