Sudafed 12 Hour

Product NDC

50090-1106

11-digit product format

500901106

Labeler code

50090

Product ID

50090-1106_5b288d47-9a57-46dd-a667-b31702079613

Type

HUMAN OTC DRUG

Nonproprietary name

Pseudoephedrine hydrochloride

Dosage form

TABLET, FILM COATED, EXTENDED RELEASE

Route

ORAL

Labeler

A-S Medication Solutions

Application

ANDA073585

Marketing category

ANDA

Marketing start

2008-06-01

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