epogen

Generic: epoetin alfa

Labeler: amgen, inc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name epogen
Generic Name epoetin alfa
Labeler amgen, inc
Dosage Form SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

epoetin 20000 [iU]/mL

Manufacturer
Amgen, Inc

Identifiers & Regulatory

Product NDC 55513-478
Product ID 55513-478_79ccf986-8ff8-4318-9a40-4c5d9f3ae9fd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA103234
Listing Expiration 2026-12-31
Marketing Start 1997-03-03

Pharmacologic Class

Classes
erythropoiesis-stimulating agent [epc] erythropoietin [cs] increased erythroid cell production [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55513478
Hyphenated Format 55513-478

Supplemental Identifiers

RxCUI
205912 205917 205921 205923 212218 239998 239999 240000 240377 241999 1721684 1721685
UNII
64FS3BFH5W

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name epogen (source: ndc)
Generic Name epoetin alfa (source: ndc)
Application Number BLA103234 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 20000 [iU]/mL
source: ndc
Packaging
  • 10 VIAL in 1 PACKAGE (55513-478-10) / 1 mL in 1 VIAL (55513-478-01)
  • 10 VIAL in 1 PACKAGE (55513-478-20) / 1 mL in 1 VIAL (55513-478-01)
source: ndc

Packages (2)

55513-478-10 10 VIAL in 1 PACKAGE (55513-478-10) / 1 mL in 1 VIAL (55513-478-01) 55513-478-20 10 VIAL in 1 PACKAGE (55513-478-20) / 1 mL in 1 VIAL (55513-478-01)

Ingredients (1)

epoetin (20000 [iU]/mL)

Linked Drug Pages (1)

EPOGEN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "79ccf986-8ff8-4318-9a40-4c5d9f3ae9fd", "openfda": {"unii": ["64FS3BFH5W"], "rxcui": ["205912", "205917", "205921", "205923", "212218", "239998", "239999", "240000", "240377", "241999", "1721684", "1721685"], "spl_set_id": ["1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5"], "manufacturer_name": ["Amgen, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 PACKAGE (55513-478-10)  / 1 mL in 1 VIAL (55513-478-01)", "package_ndc": "55513-478-10", "marketing_start_date": "19970303"}, {"sample": false, "description": "10 VIAL in 1 PACKAGE (55513-478-20)  / 1 mL in 1 VIAL (55513-478-01)", "package_ndc": "55513-478-20", "marketing_start_date": "20250414"}], "brand_name": "EPOGEN", "product_id": "55513-478_79ccf986-8ff8-4318-9a40-4c5d9f3ae9fd", "dosage_form": "SOLUTION", "pharm_class": ["Erythropoiesis-stimulating Agent [EPC]", "Erythropoietin [CS]", "Increased Erythroid Cell Production [PE]"], "product_ndc": "55513-478", "generic_name": "epoetin alfa", "labeler_name": "Amgen, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "EPOGEN", "active_ingredients": [{"name": "EPOETIN", "strength": "20000 [iU]/mL"}], "application_number": "BLA103234", "marketing_category": "BLA", "marketing_start_date": "19970303", "listing_expiration_date": "20261231"}