Memantine Hydrochloride

Product NDC

0378-1103

11-digit product format

003781103

Labeler code

0378

Product ID

0378-1103_4b207674-ac13-44ea-a422-834a9e86d7f6

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

memantine

Dosage form

TABLET

Route

ORAL

Labeler

Mylan Pharmaceuticals Inc.

Application

ANDA079225

Marketing category

ANDA

Marketing start

2015-07-11

Marketing end

2019-10-31

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

0000-00-00

Current FDA listing

Historical FDA.report record