NDC 58468-0160

Lumizyme

Alglucosidase Alfa

Lumizyme is a Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Genzyme Corporation. The primary component is Alglucosidase Alfa.

Product ID58468-0160_00f8e613-9d69-41c2-a6e0-a036a9a82516
NDC58468-0160
Product TypeHuman Prescription Drug
Proprietary NameLumizyme
Generic NameAlglucosidase Alfa
Dosage FormInjection, Powder, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2010-05-24
Marketing CategoryBLA / BLA
Application NumberBLA125291
Labeler NameGenzyme Corporation
Substance NameALGLUCOSIDASE ALFA
Active Ingredient Strength5 mg/mL
Pharm Classesalpha-Glucosidases [CS],Hydrolytic Lysosomal Glycogen-specific Enzyme [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 58468-0160-1

1 VIAL, SINGLE-USE in 1 CARTON (58468-0160-1) > 10.5 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2010-05-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58468-0160-2 [58468016002]

Lumizyme INJECTION, POWDER, FOR SOLUTION
Marketing CategoryBLA
Application NumberBLA125291
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-05-24

NDC 58468-0160-1 [58468016001]

Lumizyme INJECTION, POWDER, FOR SOLUTION
Marketing CategoryBLA
Application NumberBLA125291
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-05-24

Drug Details

Active Ingredients

IngredientStrength
ALGLUCOSIDASE ALFA5 mg/mL

OpenFDA Data

SPL SET ID:d6bfbc45-2d34-439e-8aad-59ee2d53d4df
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 629568
  • 993072
  • Pharmacological Class

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

    Trademark Results [Lumizyme]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    LUMIZYME
    LUMIZYME
    78838694 not registered Dead/Abandoned
    GENZYME CORPORATION
    2006-03-16
    LUMIZYME
    LUMIZYME
    78131965 not registered Dead/Abandoned
    Genzyme Corporation
    2002-05-30
    LUMIZYME
    LUMIZYME
    77870953 3843069 Live/Registered
    GENZYME CORPORATION
    2009-11-12

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