XENPOZYME

UNIISPLATC A16AB25

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

Identification

ManufacturerGenzyme Corporation

CountryUS (United States)

ATC codeA16AB25

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5846800501
1 VIAL in 1 CARTON (58468-0050-1) / 5.1 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

6D5766Q4OP

OLIPUDASE ALFA

RxCUI 2610407

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "6D5766Q4OP",
    "rxcui": "2610407",
    "inchikey": null,
    "display_name": "OLIPUDASE ALFA",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "01a910ee-a33e-4be3-ac41-322d64c34311": {
      "match": "brand_token",
      "title": "XENPOZYME (OLIPUDASE ALFA-RPCP) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION]",
      "spl_version": "10",
      "published_date": "2025-12-15"
    }
  },
  "productid": "58468-0050_ce8d4153-ce95-43c4-9672-e1e951ebcdaa",
  "productndc": "58468-0050",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OLIPUDASE ALFA",
  "proprietary_name": "XENPOZYME",
  "active_ingred_unit": "mg/5.1mL",
  "application_number": "BLA761261",
  "marketing_category": "BLA",
  "nonproprietary_name": "olipudase alfa-rpcp",
  "start_marketing_date": "20220829",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code A16AB25.

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