ELAPRASE

UNIISPLATC A16AB09

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

Identification

ManufacturerTakeda Pharmaceuticals America, Inc.

CountryUS (United States)

ATC codeA16AB09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5409270001
1 VIAL, GLASS in 1 BOX (54092-700-01) / 3 mL in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)

5W8JGG2651

IDURSULFASE

RxCUI 644101

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "5W8JGG2651",
    "rxcui": "644101",
    "inchikey": null,
    "display_name": "IDURSULFASE",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "60cba843-5aab-4dd7-96dc-66648d413be3": {
      "match": "brand_token",
      "title": "ELAPRASE (IDURSULFASE) SOLUTION, CONCENTRATE [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
      "spl_version": "25",
      "published_date": "2025-04-18"
    }
  },
  "productid": "54092-700_25f45811-e646-4342-9954-d8220cadf886",
  "productndc": "54092-700",
  "dosage_form": "SOLUTION, CONCENTRATE",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IDURSULFASE",
  "proprietary_name": "ELAPRASE",
  "active_ingred_unit": "mg/3mL",
  "application_number": "BLA125151",
  "marketing_category": "BLA",
  "nonproprietary_name": "idursulfase",
  "start_marketing_date": "20060724",
  "active_numerator_strength": "6"
}

Related drugs

Other records sharing ATC code A16AB09.

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