Terbinafine

Product NDC

67405-543

11-digit product format

674050543

Labeler code

67405

Product ID

67405-543_6154aa0a-55b4-478b-9edd-503a96ec0dac

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Terbinafine

Dosage form

TABLET

Route

ORAL

Labeler

HARRIS Pharmaceutical, Inc.

Application

ANDA077919

Marketing category

ANDA

Marketing start

2007-07-30

Marketing end

0000-00-00

Substance

TERBINAFINE HYDROCHLORIDE

Active strength

250 mg/1

Pharmacologic classes

Allylamine [CS],Allylamine Antifungal [EPC]

NDC exclude flag

E

Listing certified through

2018-12-31

Current FDA listing

Historical FDA.report record