memantine hydrochloride
These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE TABLETS. MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003
Approved
Approval ID
c343b0c5-3bfc-4b94-9483-a56924f6dcdb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2022
Manufacturers
FDA
POLYGEN PHARMACEUTICALS INC.
DUNS: 962415720
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
memantine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52605-071
Application NumberANDA210587
Product Classification
M
Marketing Category
C73584
G
Generic Name
memantine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2022
FDA Product Classification
INGREDIENTS (10)
MEMANTINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: JY0WD0UA60
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
Memantine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52605-072
Application NumberANDA210587
Product Classification
M
Marketing Category
C73584
G
Generic Name
Memantine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2022
FDA Product Classification
INGREDIENTS (9)
MEMANTINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: JY0WD0UA60
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT