Memantine
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
7a40ed9d-8853-b616-ff47-0c7b0fd28959
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 26, 2023
Manufacturers
FDA
NorthStar RxLLC
DUNS: 830546433
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Memantine
PRODUCT DETAILS
NDC Product Code72603-118
Application NumberANDA090048
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 26, 2023
Generic NameMemantine
INGREDIENTS (12)
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Memantine HydrochlorideActive
Quantity: 5 mg in 1 1
Code: JY0WD0UA60
Classification: ACTIB
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
PovidoneInactive
Code: FZ989GH94E
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Fd&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
Fd&C Blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
Polyethylene Glycol, UnspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
HypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Memantine
PRODUCT DETAILS
NDC Product Code72603-119
Application NumberANDA090048
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 26, 2023
Generic NameMemantine
INGREDIENTS (13)
Memantine HydrochlorideActive
Quantity: 10 mg in 1 1
Code: JY0WD0UA60
Classification: ACTIB
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
HypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Fd&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
Fd&C Blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
Polyethylene Glycol, UnspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
Ferrosoferric OxideInactive
Code: XM0M87F357
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
PovidoneInactive
Code: FZ989GH94E
Classification: IACT