lumizyme

Generic: alglucosidase alfa

Labeler: genzyme corporation
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name lumizyme
Generic Name alglucosidase alfa
Labeler genzyme corporation
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

alglucosidase alfa 5 mg/mL

Manufacturer
Genzyme Corporation

Identifiers & Regulatory

Product NDC 58468-0160
Product ID 58468-0160_26b8bca9-7139-453b-afaa-2474ca711fc2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125291
Listing Expiration 2026-12-31
Marketing Start 2010-05-24

Pharmacologic Class

Established (EPC)
hydrolytic lysosomal glycogen-specific enzyme [epc]
Chemical Structure
alpha-glucosidases [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 584680160
Hyphenated Format 58468-0160

Supplemental Identifiers

RxCUI
629568 993072
UNII
DTI67O9503
NUI
M0000794 N0000175821

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name lumizyme (source: ndc)
Generic Name alglucosidase alfa (source: ndc)
Application Number BLA125291 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (58468-0160-1) / 10.5 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

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

Ingredients (1)

alglucosidase alfa (5 mg/mL)

Linked Drug Pages (1)

Lumizyme ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "26b8bca9-7139-453b-afaa-2474ca711fc2", "openfda": {"nui": ["M0000794", "N0000175821"], "unii": ["DTI67O9503"], "rxcui": ["629568", "993072"], "spl_set_id": ["d6bfbc45-2d34-439e-8aad-59ee2d53d4df"], "pharm_class_cs": ["alpha-Glucosidases [CS]"], "pharm_class_epc": ["Hydrolytic Lysosomal Glycogen-specific Enzyme [EPC]"], "manufacturer_name": ["Genzyme Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (58468-0160-1)  / 10.5 mL in 1 VIAL, SINGLE-USE", "package_ndc": "58468-0160-1", "marketing_start_date": "20100524"}], "brand_name": "Lumizyme", "product_id": "58468-0160_26b8bca9-7139-453b-afaa-2474ca711fc2", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Hydrolytic Lysosomal Glycogen-specific Enzyme [EPC]", "alpha-Glucosidases [CS]"], "product_ndc": "58468-0160", "generic_name": "ALGLUCOSIDASE ALFA", "labeler_name": "Genzyme Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lumizyme", "active_ingredients": [{"name": "ALGLUCOSIDASE ALFA", "strength": "5 mg/mL"}], "application_number": "BLA125291", "marketing_category": "BLA", "marketing_start_date": "20100524", "listing_expiration_date": "20261231"}