fabrazyme

Generic: agalsidase beta

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

Drug Facts

Product Profile

Brand Name fabrazyme
Generic Name agalsidase beta
Labeler genzyme corporation
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

agalsidase beta 5 mg/mL

Manufacturer
Genzyme Corporation

Identifiers & Regulatory

Product NDC 58468-0040
Product ID 58468-0040_9b786f81-f4d8-4bc6-8f5f-68adbbfb60d1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA103979
Listing Expiration 2026-12-31
Marketing Start 2008-12-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 584680040
Hyphenated Format 58468-0040

Supplemental Identifiers

RxCUI
1804755 1804758 1804760 1804762
UNII
RZD65TSM9U
NUI
M0000794 N0000175822

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 fabrazyme (source: ndc)
Generic Name agalsidase beta (source: ndc)
Application Number BLA103979 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (58468-0040-1) / 7 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

58468-0040-1 1 VIAL, GLASS in 1 CARTON (58468-0040-1) / 7 mL in 1 VIAL, GLASS

Ingredients (1)

agalsidase beta (5 mg/mL)

Linked Drug Pages (1)

Fabrazyme ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "9b786f81-f4d8-4bc6-8f5f-68adbbfb60d1", "openfda": {"nui": ["M0000794", "N0000175822"], "unii": ["RZD65TSM9U"], "rxcui": ["1804755", "1804758", "1804760", "1804762"], "spl_set_id": ["988513ab-b06f-4dd0-93f7-d2d4531dcce4"], "pharm_class_cs": ["alpha-Glucosidases [CS]"], "pharm_class_epc": ["Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme [EPC]"], "manufacturer_name": ["Genzyme Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (58468-0040-1)  / 7 mL in 1 VIAL, GLASS", "package_ndc": "58468-0040-1", "marketing_start_date": "20081217"}], "brand_name": "Fabrazyme", "product_id": "58468-0040_9b786f81-f4d8-4bc6-8f5f-68adbbfb60d1", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme [EPC]", "alpha-Glucosidases [CS]"], "product_ndc": "58468-0040", "generic_name": "AGALSIDASE BETA", "labeler_name": "Genzyme Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fabrazyme", "active_ingredients": [{"name": "AGALSIDASE BETA", "strength": "5 mg/mL"}], "application_number": "BLA103979", "marketing_category": "BLA", "marketing_start_date": "20081217", "listing_expiration_date": "20261231"}