NDC 55513-478

EPOGEN

Epoetin Alfa

EPOGEN is a Intravenous; Subcutaneous Solution in the Human Prescription Drug category. It is labeled and distributed by Amgen Inc. The primary component is Erythropoietin.

• Product ID: 55513-478_0b8ee1a8-d7d1-46c9-b688-6fbd8dcaccca
• NDC: 55513-478
• Product Type: Human Prescription Drug
• Proprietary Name: EPOGEN
• Generic Name: Epoetin Alfa
• Dosage Form: Solution
• Route of Administration: INTRAVENOUS; SUBCUTANEOUS
• Marketing Start Date: 1997-03-03
• Marketing Category: BLA / BLA
• Application Number: BLA103234
• Labeler Name: Amgen Inc
• Substance Name: ERYTHROPOIETIN
• Active Ingredient Strength: 20000 [iU]/mL
• Pharm Classes: Erythropoiesis-stimulating Agent [EPC],Erythropoietin [CS],Increased Erythroid Cell Production [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 55513-478-10

10 VIAL in 1 PACKAGE (55513-478-10) > 1 mL in 1 VIAL (55513-478-01)

• Marketing Start Date: 1997-03-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55513-478-01 [55513047801]

EPOGEN SOLUTION

• Marketing Category: BLA
• Application Number: BLA103234
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1997-03-03

NDC 55513-478-10 [55513047810]

EPOGEN SOLUTION

• Marketing Category: BLA
• Application Number: BLA103234
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1997-03-03

Drug Details

Active Ingredients

Ingredient	Strength
ERYTHROPOIETIN	20000 [iU]/mL

OpenFDA Data

• SPL SET ID: 1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5
• Manufacturer:
  • Amgen Inc
• UNII:
  • 64FS3BFH5W
• RxNorm Concept Unique ID - RxCUI:
  • 240000
  • 1721685
  • 239998
  • 239999
  • 205912
  • 205917
  • 212218
  • 205921
  • 205923
  • 241999
  • 1721684
  • 240377

Pharmacological Class

• Erythropoiesis-stimulating Agent [EPC]
• Erythropoietin [CS]
• Increased Erythroid Cell Production [PE]

NDC Crossover Matching brand name "EPOGEN" or generic name "Epoetin Alfa"

NDC	Brand Name	Generic Name
55513-126	EPOGEN	epoetin alfa
55513-144	EPOGEN	epoetin alfa
55513-148	EPOGEN	epoetin alfa
55513-267	EPOGEN	epoetin alfa
55513-283	EPOGEN	epoetin alfa
55513-478	EPOGEN	epoetin alfa