Guaifenesin and pseudoephedrine hydrochloride Extended Release

Product NDC

70518-0011

11-digit product format

705180011

Labeler code

70518

Product ID

70518-0011_41daf24d-4a93-0f9d-e054-00144ff8d46c

Type

HUMAN OTC DRUG

Nonproprietary name

Guaifenesin, pseudoephedrine hydrochloride

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Labeler

REMEDYREPACK INC.

Application

ANDA091071

Marketing category

ANDA

Marketing start

2016-11-21

Marketing end

0000-00-00

Substance

GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

Active strength

600 mg/1; mg/1

NDC exclude flag

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record