aldurazyme

Generic: laronidase

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

Drug Facts

Product Profile

Brand Name aldurazyme
Generic Name laronidase
Labeler genzyme corporation
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

laronidase 2.9 mg/5mL

Manufacturer
Genzyme Corporation

Identifiers & Regulatory

Product NDC 58468-0070
Product ID 58468-0070_a6819483-3275-4b44-8e87-f6246503af43
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125058
Listing Expiration 2026-12-31
Marketing Start 2003-04-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 584680070
Hyphenated Format 58468-0070

Supplemental Identifiers

RxCUI
403822 404492
UNII
WP58SVM6R4
NUI
M0000794 N0000175823

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 aldurazyme (source: ndc)
Generic Name laronidase (source: ndc)
Application Number BLA125058 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2.9 mg/5mL
source: ndc
Packaging
  • 5 mL in 1 VIAL, GLASS (58468-0070-1)
source: ndc

Packages (1)

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

Ingredients (1)

laronidase (2.9 mg/5mL)

Linked Drug Pages (1)

ALDURAZYME ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "a6819483-3275-4b44-8e87-f6246503af43", "openfda": {"nui": ["M0000794", "N0000175823"], "unii": ["WP58SVM6R4"], "rxcui": ["403822", "404492"], "spl_set_id": ["a80ac249-cae4-41f3-88bb-344088b20e60"], "pharm_class_cs": ["alpha-Glucosidases [CS]"], "pharm_class_epc": ["Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC]"], "manufacturer_name": ["Genzyme Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 VIAL, GLASS (58468-0070-1)", "package_ndc": "58468-0070-1", "marketing_start_date": "20030430"}], "brand_name": "ALDURAZYME", "product_id": "58468-0070_a6819483-3275-4b44-8e87-f6246503af43", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC]", "alpha-Glucosidases [CS]"], "product_ndc": "58468-0070", "generic_name": "laronidase", "labeler_name": "Genzyme Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ALDURAZYME", "active_ingredients": [{"name": "LARONIDASE", "strength": "2.9 mg/5mL"}], "application_number": "BLA125058", "marketing_category": "BLA", "marketing_start_date": "20030430", "listing_expiration_date": "20261231"}