Namenda
Namenda
Approved
Approval ID
74ce605d-b493-4b95-9d59-9253f81f4e20
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-169
Application NumberNDA021487
Product Classification
M
Marketing Category
C73594
G
Generic Name
memantine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 22, 2009
FDA Product Classification
INGREDIENTS (10)
MEMANTINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: JY0WD0UA60
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
memantine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-232
Application NumberNDA021487
Product Classification
M
Marketing Category
C73594
G
Generic Name
memantine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 22, 2009
FDA Product Classification
INGREDIENTS (11)
MEMANTINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: JY0WD0UA60
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT