Amantadine Hydrochloride

Product NDC

55289-012

11-digit product format

552890012

Labeler code

55289

Product ID

55289-012_7bad8ad7-3a13-4a5b-e053-2991aa0aee05

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

amantadine hydrochloride

Dosage form

CAPSULE, GELATIN COATED

Route

ORAL

Labeler

PD-Rx Pharmaceuticals, Inc.

Application

ANDA070589

Marketing category

ANDA

Marketing start

2011-09-15

Marketing end

0000-00-00

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

2019-12-31

Current FDA listing

Historical FDA.report record