12 hour decongestant

Product NDC

0113-2054

11-digit product format

001132054

Labeler code

0113

Product ID

0113-2054_1d18dfcf-0404-4fce-b469-efd062080f9a

Type

HUMAN OTC DRUG

Nonproprietary name

Pseudoephedrine Hydrochloride

Dosage form

TABLET, FILM COATED, EXTENDED RELEASE

Route

ORAL

Labeler

L. Perrigo Company

Application

ANDA075153

Marketing category

ANDA

Marketing start

2011-10-04

Marketing end

0000-00-00

Substance

PSEUDOEPHEDRINE HYDROCHLORIDE

Active strength

120 mg/1

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record