Memantine Hydrochloride
These highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for memantine hydrochloride. MEMANTINE hydrochloride tablets, for oral useInitial U.S. Approval: 2003
Approved
Approval ID
b2b5d6e0-6f8c-4b3a-9466-5df67c6c6846
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 5, 2020
Manufacturers
FDA
CELLTRION USA, INC.
DUNS: 116587378
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 Code72606-515
Application NumberANDA090073
Product Classification
M
Marketing Category
C73584
G
Generic Name
Memantine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 5, 2020
FDA Product Classification
INGREDIENTS (10)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MEMANTINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: JY0WD0UA60
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
Memantine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72606-514
Application NumberANDA090073
Product Classification
M
Marketing Category
C73584
G
Generic Name
Memantine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 5, 2020
FDA Product Classification
INGREDIENTS (11)
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MEMANTINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: JY0WD0UA60
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT