galantamine
These highlights do not include all the information needed to use GALANTAMINE TABLETS safely and effectively. See full prescribing information for GALANTAMINE TABLETS. GALANTAMINE tablets, for oral useInitial U.S. Approval: 2001
Approved
Approval ID
8f07d397-e814-41c8-a7f3-fd666b208cfb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 9, 2022
Manufacturers
FDA
Zydus Pharmaceuticals USA Inc.
DUNS: 156861945
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
galantamine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-179
Application NumberANDA078898
Product Classification
M
Marketing Category
C73584
G
Generic Name
galantamine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 9, 2022
FDA Product Classification
INGREDIENTS (9)
GALANTAMINE HYDROBROMIDEActive
Quantity: 12 mg in 1 1
Code: MJ4PTD2VVW
Classification: ACTIM
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
galantamine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-178
Application NumberANDA078898
Product Classification
M
Marketing Category
C73584
G
Generic Name
galantamine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 9, 2022
FDA Product Classification
INGREDIENTS (9)
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
GALANTAMINE HYDROBROMIDEActive
Quantity: 8 mg in 1 1
Code: MJ4PTD2VVW
Classification: ACTIM
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
galantamine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-177
Application NumberANDA078898
Product Classification
M
Marketing Category
C73584
G
Generic Name
galantamine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 9, 2022
FDA Product Classification
INGREDIENTS (9)
GALANTAMINE HYDROBROMIDEActive
Quantity: 4 mg in 1 1
Code: MJ4PTD2VVW
Classification: ACTIM
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT