Galantamine Hydrobromide
These highlights do not include all the information needed to use galantaminehydrobromide safely and effectively. See full prescribing information forGalantamine Hydrobromide Tablets, USP. Galantamine Hydrobromide Tablets, USP for oral useInitial U.S. Approval: 2001
Approved
Approval ID
7dc963dd-84d6-45f3-857f-46a44fe9edc8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 15, 2015
Manufacturers
FDA
Yabao Pharmaceutical Co., Ltd. Beijing
DUNS: 421252976
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 Code51990-111
Application NumberNDA021169
Product Classification
M
Marketing Category
C73594
G
Generic Name
galantamine hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateMay 28, 2015
FDA Product Classification
INGREDIENTS (12)
galantamine hydrobromideActive
Quantity: 4 mg in 1 1
Code: MJ4PTD2VVW
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE E)Inactive
Code: 66O7AQV0RT
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
galantamine hydrobromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51990-112
Application NumberNDA021169
Product Classification
M
Marketing Category
C73594
G
Generic Name
galantamine hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateMay 28, 2015
FDA Product Classification
INGREDIENTS (13)
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
galantamine hydrobromideActive
Quantity: 8 mg in 1 1
Code: MJ4PTD2VVW
Classification: ACTIM
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE E)Inactive
Code: 66O7AQV0RT
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
galantamine hydrobromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51990-113
Application NumberNDA021169
Product Classification
M
Marketing Category
C73594
G
Generic Name
galantamine hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateMay 28, 2015
FDA Product Classification
INGREDIENTS (13)
galantamine hydrobromideActive
Quantity: 12 mg in 1 1
Code: MJ4PTD2VVW
Classification: ACTIM
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE E)Inactive
Code: 66O7AQV0RT
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT