Memantine Hydrochloride

Product NDC

68382-388

11-digit product format

683820388

Labeler code

68382

Product ID

68382-388_5cf85a8a-effe-4207-8b72-e91e8c4f4650

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Memantine Hydrochloride

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Zydus Pharmaceuticals (USA) Inc.

Application

ANDA090961

Marketing category

ANDA

Marketing start

2017-09-28

Marketing end

0000-00-00

Substance

MEMANTINE HYDROCHLORIDE

Active strength

5 mg/1

Pharmacologic classes

NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record