Topcare fexofenadine hydrochloride

Product NDC

36800-425

11-digit product format

368000425

Labeler code

36800

Product ID

36800-425_41afb87f-6f53-4910-b659-d80592b0ca84

Type

HUMAN OTC DRUG

Nonproprietary name

Fexofenadine HCl

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Topco Associates LLC

Application

ANDA076447

Marketing category

ANDA

Marketing start

2011-09-02

Marketing end

2021-01-31

Substance

FEXOFENADINE HYDROCHLORIDE

Active strength

60 mg/1

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record