Miglustat
These highlights do not include all the information needed to use MIGLUSTAT CAPSULES safely and effectively. See full prescribing information for MIGLUSTAT CAPSULES. MIGLUSTAT capsules, for oral use Initial U.S. Approval: 2003
Approved
Approval ID
b54cc8a0-2284-44c3-a8fa-d8aaa87a67c6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 17, 2025
Manufacturers
FDA
Zydus Pharmaceuticals USA Inc.
DUNS: 156861945
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Miglustat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70710-2039
Application NumberANDA219111
Product Classification
M
Marketing Category
C73584
G
Generic Name
Miglustat
Product Specifications
Route of AdministrationORAL
Effective DateMarch 17, 2025
FDA Product Classification
INGREDIENTS (9)
MIGLUSTATActive
Quantity: 100 mg in 1 1
Code: ADN3S497AZ
Classification: ACTIB
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT