NDC 58468-0041

Fabrazyme

Agalsidase Beta

Fabrazyme is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Genzyme Corporation. The primary component is Agalsidase Beta.

Product ID58468-0041_0339a000-641e-4081-8901-4d000be85390
NDC58468-0041
Product TypeHuman Prescription Drug
Proprietary NameFabrazyme
Generic NameAgalsidase Beta
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2008-12-17
Marketing CategoryBLA / BLA
Application NumberBLA103979
Labeler NameGenzyme Corporation
Substance NameAGALSIDASE BETA
Active Ingredient Strength5 mg/mL
Pharm Classesalpha-Glucosidases [CS],Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 58468-0041-1

1 VIAL, GLASS in 1 CARTON (58468-0041-1) > 1 mL in 1 VIAL, GLASS
Marketing Start Date2008-12-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58468-0041-1 [58468004101]

Fabrazyme INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryBLA
Application NumberBLA103979
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-12-17

Drug Details

Active Ingredients

IngredientStrength
AGALSIDASE BETA5 mg/mL

OpenFDA Data

SPL SET ID:988513ab-b06f-4dd0-93f7-d2d4531dcce4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1804755
  • 1804762
  • 1804758
  • 1804760
  • Pharmacological Class

    • alpha-Glucosidases [CS]
    • Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme [EPC]

    NDC Crossover Matching brand name "Fabrazyme" or generic name "Agalsidase Beta"

    NDCBrand NameGeneric Name
    58468-0040FabrazymeAGALSIDASE BETA
    58468-0041FabrazymeAGALSIDASE BETA

    Trademark Results [Fabrazyme]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    FABRAZYME
    FABRAZYME
    75844246 2528286 Live/Registered
    GENZYME THERAPEUTIC PRODUCTS LIMITED PARTNERSHIP
    1999-11-10

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