Amantadine Hydrochloride

Product NDC

51079-247

11-digit product format

510790247

Labeler code

51079

Product ID

51079-247_7b1ad44d-ce68-2ffa-e053-2991aa0a432f

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Amantadine Hydrochloride

Dosage form

CAPSULE

Route

ORAL

Labeler

Mylan Institutional Inc.

Application

ANDA071293

Marketing category

ANDA

Marketing start

2012-12-28

Marketing end

2019-06-30

Substance

AMANTADINE HYDROCHLORIDE

Active strength

100 mg/1

Pharmacologic classes

Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record