Memantine Hydrochloride

Basic Information

Product Name

FDA Product Code

62980-122

Regulatory Information

NDC Product Code

62980-122

Application Number

ANDA090073

Marketing Category

C73584

Effective Date

May 27, 2015

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

MEMANTINE HYDROCHLORIDE

Quantity: 10 mg in 1 1

Code: JY0WD0UA60

Class Code: ACTIB

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

TRIACETIN

Code: XHX3C3X673

Class Code: IACT

Active Moieties

MEMANTINE

Code: W8O17SJF3T

Basic Information

Regulatory Information

Company Information

Active Ingredients

FERROSOFERRIC OXIDE

MAGNESIUM STEARATE

CROSCARMELLOSE SODIUM

HYPROMELLOSES

CELLULOSE, MICROCRYSTALLINE

TITANIUM DIOXIDE

TALC

SILICON DIOXIDE

TRIACETIN

Active Moieties

MEMANTINE