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United States · US · US:59353-010_5626304b-344f-4155-9afa-d7cfe733d819

RETACRIT

UNIISPL

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerVifor (International) Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5935301010
    10 VIAL, SINGLE-DOSE in 1 CARTON (59353-010-10) / 1 mL in 1 VIAL, SINGLE-DOSE (59353-010-01)

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": {
    "3af26b0d-8ad0-44e1-a538-8bdb5ab39374": {
      "match": "brand_token",
      "title": "RETACRIT (EPOETIN ALFA-EPBX) INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]",
      "spl_version": "19",
      "published_date": "2025-06-26"
    }
  },
  "productid": "59353-010_5626304b-344f-4155-9afa-d7cfe733d819",
  "productndc": "59353-010",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EPOETIN",
  "proprietary_name": "RETACRIT",
  "active_ingred_unit": "[iU]/mL",
  "application_number": "BLA125545",
  "marketing_category": "BLA",
  "nonproprietary_name": "epoetin alfa-epbx",
  "start_marketing_date": "20180618",
  "active_numerator_strength": "10000"
}

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