NDC 58468-1983

Cerezyme

Imiglucerase

Cerezyme 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 Imiglucerase.

Product ID58468-1983_32c3b588-388f-4e22-8fc7-af0f8b992755
NDC58468-1983
Product TypeHuman Prescription Drug
Proprietary NameCerezyme
Generic NameImiglucerase
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date1994-05-23
Marketing CategoryNDA / NDA
Application NumberNDA020367
Labeler NameGenzyme Corporation
Substance NameIMIGLUCERASE
Active Ingredient Strength40 U/mL
Pharm ClassesGlucosylceramidase [CS],Hydrolytic Lysosomal Glucocerebroside-specific Enzyme [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 58468-1983-1

1 VIAL, GLASS in 1 CARTON (58468-1983-1) > 5 mL in 1 VIAL, GLASS
Marketing Start Date1994-05-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58468-1983-1 [58468198301]

Cerezyme INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryBLA
Application NumberBLA020367
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1994-05-23

Drug Details

Active Ingredients

IngredientStrength
IMIGLUCERASE40 U/mL

OpenFDA Data

SPL SET ID:df60f030-866b-4374-a31f-8ae3f6b45c38
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1726260
  • 1726257
  • 1726268
  • 1726266
  • Pharmacological Class

    • Glucosylceramidase [CS]
    • Hydrolytic Lysosomal Glucocerebroside-specific Enzyme [EPC]

    NDC Crossover Matching brand name "Cerezyme" or generic name "Imiglucerase"

    NDCBrand NameGeneric Name
    58468-1983CerezymeIMIGLUCERASE
    58468-4663CerezymeIMIGLUCERASE

    Trademark Results [Cerezyme]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CEREZYME
    CEREZYME
    97534496 not registered Live/Pending
    Genzyme Corporation
    2022-08-04
    CEREZYME
    CEREZYME
    79031720 3856812 Dead/Cancelled
    Novozymes Switzerland AG
    2006-11-09
    CEREZYME
    CEREZYME
    77441609 4088201 Live/Registered
    Genzyme Corporation
    2008-04-07
    CEREZYME
    CEREZYME
    74481041 1912218 Live/Registered
    GENZYME THERAPEUTIC PRODUCTS LIMITED PARTNERSHIP
    1994-01-21

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