SudoGest

Product NDC

0904-5803

11-digit product format

009045803

Labeler code

0904

Product ID

0904-5803_728a3e68-532a-410b-b67c-6d53e54003f3

Type

HUMAN OTC DRUG

Nonproprietary name

Pseudoephedrine Hydrochloride

Dosage form

TABLET, FILM COATED, EXTENDED RELEASE

Route

ORAL

Labeler

Major Pharmaceuticals

Application

ANDA077442

Marketing category

ANDA

Marketing start

2006-04-28

Marketing end

2020-08-31

Substance

PSEUDOEPHEDRINE HYDROCHLORIDE

Active strength

120 mg/1

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record