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
2ac7d23c-5f9f-4ffc-ae01-d7099a8a7929
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 27, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
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 Code71335-1908
Application NumberANDA090058
Product Classification
M
Marketing Category
C73584
G
Generic Name
Memantine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 11, 2020
FDA Product Classification
INGREDIENTS (10)
MEMANTINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: JY0WD0UA60
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT