Fabrazyme

UNIISPLATC A16AB04

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

Identification

ManufacturerGenzyme Corporation

CountryUS (United States)

ATC codeA16AB04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5846800401
1 VIAL, GLASS in 1 CARTON (58468-0040-1) / 7 mL in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)

RZD65TSM9U

AGALSIDASE BETA

RxCUI 338817

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "RZD65TSM9U",
    "rxcui": "338817",
    "inchikey": null,
    "display_name": "AGALSIDASE BETA",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "988513ab-b06f-4dd0-93f7-d2d4531dcce4": {
      "match": "brand_token",
      "title": "FABRAZYME (AGALSIDASE BETA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION]",
      "spl_version": "35",
      "published_date": "2025-08-25"
    }
  },
  "productid": "58468-0040_9b786f81-f4d8-4bc6-8f5f-68adbbfb60d1",
  "productndc": "58468-0040",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AGALSIDASE BETA",
  "proprietary_name": "Fabrazyme",
  "active_ingred_unit": "mg/mL",
  "application_number": "BLA103979",
  "marketing_category": "BLA",
  "nonproprietary_name": "AGALSIDASE BETA",
  "start_marketing_date": "20081217",
  "active_numerator_strength": "5"
}

Related drugs

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