Sudafed 12 Hour

Product NDC

50580-670

11-digit product format

505800670

Labeler code

50580

Product ID

50580-670_f6cc4ab8-ce62-4811-a55e-ace614fee4b8

Type

HUMAN OTC DRUG

Nonproprietary name

Pseudoephedrine hydrochloride

Dosage form

TABLET, FILM COATED, EXTENDED RELEASE

Route

ORAL

Labeler

Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

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