Cerezyme
These highlights do not include all the information needed to use CEREZYME safely and effectively. See full prescribing information for CEREZYME. CEREZYME (imiglucerase) for injection, for intravenous use Initial U.S. Approval: 1994
Approved
Approval ID
df60f030-866b-4374-a31f-8ae3f6b45c38
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 10, 2018
Manufacturers
FDA
Genzyme Corporation
DUNS: 025322157
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
IMIGLUCERASE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code58468-4663
Application NumberBLA020367
Product Classification
M
Marketing Category
C73585
G
Generic Name
IMIGLUCERASE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 10, 2018
FDA Product Classification
INGREDIENTS (5)
DISODIUM HYDROGEN CITRATEInactive
Quantity: 3.4 mg in 1 mL
Code: 6FO62KCQ7A
Classification: IACT
IMIGLUCERASEActive
Quantity: 40 U in 1 mL
Code: Q6U6J48BWY
Classification: ACTIB
MANNITOLInactive
Quantity: 32.08 mg in 1 mL
Code: 3OWL53L36A
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.1 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 9.81 mg in 1 mL
Code: B22547B95K
Classification: IACT