EPOGEN

UNIISPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAmgen, Inc

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5551347810
10 VIAL in 1 PACKAGE (55513-478-10) / 1 mL in 1 VIAL (55513-478-01)
ndc11
5551347820
10 VIAL in 1 PACKAGE (55513-478-20) / 1 mL in 1 VIAL (55513-478-01)

Annotations

UNII (FDA Substance ID)

64FS3BFH5W

EPOETIN

RxCUI 2047589

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "64FS3BFH5W",
    "rxcui": "2047589",
    "inchikey": null,
    "display_name": "EPOETIN",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS; SUBCUTANEOUS",
  "spl_meta": {
    "1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5": {
      "match": "brand_token",
      "title": "EPOGEN (EPOETIN ALFA) SOLUTION [AMGEN, INC]",
      "spl_version": "136",
      "published_date": "2025-11-17"
    }
  },
  "productid": "55513-478_79ccf986-8ff8-4318-9a40-4c5d9f3ae9fd",
  "productndc": "55513-478",
  "dosage_form": "SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EPOETIN",
  "proprietary_name": "EPOGEN",
  "active_ingred_unit": "[iU]/mL",
  "application_number": "BLA103234",
  "marketing_category": "BLA",
  "nonproprietary_name": "epoetin alfa",
  "start_marketing_date": "19970303",
  "active_numerator_strength": "20000"
}

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