Lumizyme

UNIISPLATC A16AB07

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

Identification

ManufacturerGenzyme Corporation

CountryUS (United States)

ATC codeA16AB07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5846801601
1 VIAL, SINGLE-USE in 1 CARTON (58468-0160-1) / 10.5 mL in 1 VIAL, SINGLE-USE

Annotations

UNII (FDA Substance ID)

DTI67O9503

ALGLUCOSIDASE ALFA

RxCUI 629565

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "DTI67O9503",
    "rxcui": "629565",
    "inchikey": null,
    "display_name": "ALGLUCOSIDASE ALFA",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "d6bfbc45-2d34-439e-8aad-59ee2d53d4df": {
      "match": "brand_token",
      "title": "LUMIZYME (ALGLUCOSIDASE ALFA) INJECTION, POWDER, FOR SOLUTION [GENZYME CORPORATION]",
      "spl_version": "21",
      "published_date": "2025-01-13"
    }
  },
  "productid": "58468-0160_26b8bca9-7139-453b-afaa-2474ca711fc2",
  "productndc": "58468-0160",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALGLUCOSIDASE ALFA",
  "proprietary_name": "Lumizyme",
  "active_ingred_unit": "mg/mL",
  "application_number": "BLA125291",
  "marketing_category": "BLA",
  "nonproprietary_name": "ALGLUCOSIDASE ALFA",
  "start_marketing_date": "20100524",
  "active_numerator_strength": "5"
}

Related drugs

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