MEMANTINE HYDROCHLORIDE
Memantine HCL
Approved
Approval ID
d0839a2d-35f1-1f14-e053-2995a90ad549
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 11, 2021
Manufacturers
FDA
DirectRx
DUNS: 079254320
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 Code72189-294
Application NumberANDA090961
Product Classification
M
Marketing Category
C73584
G
Generic Name
MEMANTINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 11, 2021
FDA Product Classification
INGREDIENTS (11)
MEMANTINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: JY0WD0UA60
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT