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Galantamine Hydrobromide

These highlights do not include all the information needed to use GALANTAMINE HYDROBROMIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for GALANTAMINE HYDROBROMIDE EXTENDED-RELEASE CAPSULES. GALANTAMINE HYDROBROMIDE extended-release capsules, for oral use Initial U.S. Approval: 2001

Approved
Approval ID

d1697161-ebe8-42b0-83e7-c9de4412546c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 26, 2023

Manufacturers
FDA

Sun Pharmaceutical Industries, Inc.

DUNS: 146974886

Products 3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Galantamine Hydrobromide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code47335-835
Application NumberANDA090178
Product Classification
M
Marketing Category
C73584
G
Generic Name
Galantamine Hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 26, 2023
FDA Product Classification

INGREDIENTS (9)

GALANTAMINE HYDROBROMIDEActive
Quantity: 8 mg in 1 1
Code: MJ4PTD2VVW
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

Galantamine Hydrobromide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code47335-836
Application NumberANDA090178
Product Classification
M
Marketing Category
C73584
G
Generic Name
Galantamine Hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 26, 2023
FDA Product Classification

INGREDIENTS (10)

GALANTAMINE HYDROBROMIDEActive
Quantity: 16 mg in 1 1
Code: MJ4PTD2VVW
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT

Galantamine Hydrobromide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code47335-837
Application NumberANDA090178
Product Classification
M
Marketing Category
C73584
G
Generic Name
Galantamine Hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 26, 2023
FDA Product Classification

INGREDIENTS (12)

STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GALANTAMINE HYDROBROMIDEActive
Quantity: 24 mg in 1 1
Code: MJ4PTD2VVW
Classification: ACTIM
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT

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