Sudafed

Product NDC

50580-539

11-digit product format

505800539

Labeler code

50580

Product ID

50580-539_ff4513f0-2263-40d0-b8ec-90237abe35dd

Type

HUMAN OTC DRUG

Nonproprietary name

Naproxen sodium and Pseudoephedrine Hydrochloride

Dosage form

TABLET, FILM COATED, EXTENDED RELEASE

Route

ORAL

Labeler

Johnson & Johnson Consume

Application

ANDA076518

Marketing category

ANDA

Marketing start

2010-11-01

Marketing end

0000-00-00

Substance

NAPROXEN SODIUM

Active strength

220 mg/1; mg/1

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record