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United States · US · US:58468-0070_a6819483-3275-4b44-8e87-f6246503af43

ALDURAZYME

UNIISPLATC A16AB05

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

Identification

ManufacturerGenzyme Corporation
CountryUS (United States)
ATC codeA16AB05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5846800701
    5 mL in 1 VIAL, GLASS (58468-0070-1)

Annotations

UNII (FDA Substance ID)
WP58SVM6R4
LARONIDASE
RxCUI 392509
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "WP58SVM6R4",
    "rxcui": "392509",
    "inchikey": null,
    "display_name": "LARONIDASE",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "a80ac249-cae4-41f3-88bb-344088b20e60": {
      "match": "brand_token",
      "title": "ALDURAZYME (LARONIDASE) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION]",
      "spl_version": "37",
      "published_date": "2025-11-26"
    }
  },
  "productid": "58468-0070_a6819483-3275-4b44-8e87-f6246503af43",
  "productndc": "58468-0070",
  "dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LARONIDASE",
  "proprietary_name": "ALDURAZYME",
  "active_ingred_unit": "mg/5mL",
  "application_number": "BLA125058",
  "marketing_category": "BLA",
  "nonproprietary_name": "laronidase",
  "start_marketing_date": "20030430",
  "active_numerator_strength": "2.9"
}

Related drugs

Other records sharing ATC code A16AB05.

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