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United States · US · US:68135-020_02482a8a-8333-4e9c-a9dc-ff7780f40363

NAGLAZYME

UNIISPLATC A16AB08

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

Identification

ManufacturerBioMarin Pharmaceutical Inc.
CountryUS (United States)
ATC codeA16AB08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6813502001
    1 VIAL in 1 CARTON (68135-020-01) / 5 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
59UA429E5G
GALSULFASE
RxCUI 578033
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "59UA429E5G",
    "rxcui": "578033",
    "inchikey": null,
    "display_name": "GALSULFASE",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "59341250-deac-ed71-3823-a4f5d64dbd77": {
      "match": "brand_token",
      "title": "NAGLAZYME (GALSULFASE) SOLUTION [BIOMARIN PHARMACEUTICAL INC.]",
      "spl_version": "39",
      "published_date": "2024-12-12"
    }
  },
  "productid": "68135-020_02482a8a-8333-4e9c-a9dc-ff7780f40363",
  "productndc": "68135-020",
  "dosage_form": "SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GALSULFASE",
  "proprietary_name": "NAGLAZYME",
  "active_ingred_unit": "mg/5mL",
  "application_number": "BLA125117",
  "marketing_category": "BLA",
  "nonproprietary_name": "galsulfase",
  "start_marketing_date": "20050609",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code A16AB08.

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