naglazyme

Generic: galsulfase

Labeler: biomarin pharmaceutical inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name naglazyme
Generic Name galsulfase
Labeler biomarin pharmaceutical inc.
Dosage Form SOLUTION
Routes
INTRAVENOUS
Active Ingredients

galsulfase 5 mg/5mL

Manufacturer
BioMarin Pharmaceutical Inc.

Identifiers & Regulatory

Product NDC 68135-020
Product ID 68135-020_02482a8a-8333-4e9c-a9dc-ff7780f40363
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125117
Listing Expiration 2026-12-31
Marketing Start 2005-06-09

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 68135020
Hyphenated Format 68135-020

Supplemental Identifiers

RxCUI
578037 584222
UNII
59UA429E5G
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 naglazyme (source: ndc)
Generic Name galsulfase (source: ndc)
Application Number BLA125117 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (68135-020-01) / 5 mL in 1 VIAL
source: ndc

Packages (1)

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

Ingredients (1)

galsulfase (5 mg/5mL)

Linked Drug Pages (1)

NAGLAZYME ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "02482a8a-8333-4e9c-a9dc-ff7780f40363", "openfda": {"nui": ["M0000794", "N0000175823"], "unii": ["59UA429E5G"], "rxcui": ["578037", "584222"], "spl_set_id": ["59341250-deac-ed71-3823-a4f5d64dbd77"], "pharm_class_cs": ["alpha-Glucosidases [CS]"], "pharm_class_epc": ["Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC]"], "manufacturer_name": ["BioMarin Pharmaceutical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68135-020-01)  / 5 mL in 1 VIAL", "package_ndc": "68135-020-01", "marketing_start_date": "20050609"}], "brand_name": "NAGLAZYME", "product_id": "68135-020_02482a8a-8333-4e9c-a9dc-ff7780f40363", "dosage_form": "SOLUTION", "pharm_class": ["Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC]", "alpha-Glucosidases [CS]"], "product_ndc": "68135-020", "generic_name": "galsulfase", "labeler_name": "BioMarin Pharmaceutical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NAGLAZYME", "active_ingredients": [{"name": "GALSULFASE", "strength": "5 mg/5mL"}], "application_number": "BLA125117", "marketing_category": "BLA", "marketing_start_date": "20050609", "listing_expiration_date": "20261231"}