NDC 25021-203

Epirubicin Hydrochloride

Epirubicin Hydrochloride

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

• Product ID: 25021-203_63a16f98-6279-4fce-966e-bd2c4e27e6e6
• NDC: 25021-203
• Product Type: Human Prescription Drug
• Proprietary Name: Epirubicin Hydrochloride
• Generic Name: Epirubicin Hydrochloride
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2014-08-31
• Marketing End Date: 2019-09-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA065361
• Labeler Name: Sagent Pharmaceuticals
• 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

Packaging

NDC 25021-203-51

1 VIAL in 1 CARTON (25021-203-51) > 100 mL in 1 VIAL

• Marketing Start Date: 2014-08-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 25021-203-51 [25021020351]

Epirubicin Hydrochloride INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA065361
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-08-31
• Marketing End Date: 2019-09-30

NDC 25021-203-25 [25021020325]

Epirubicin Hydrochloride INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA065361
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-08-31
• Marketing End Date: 2019-09-30

Drug Details

Active Ingredients

Ingredient	Strength
EPIRUBICIN HYDROCHLORIDE	2 mg/mL

OpenFDA Data

• SPL SET ID: f9a93841-f097-472a-b4a5-ee7a2aa74164
• Manufacturer:
  • Sagent Pharmaceuticals
• 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