Naproxen

Product NDC

55289-307

11-digit product format

552890307

Labeler code

55289

Product ID

55289-307_7c1ebf5a-0b5d-dd0f-e053-2991aa0a1296

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Naproxen

Dosage form

TABLET, DELAYED RELEASE

Route

ORAL

Labeler

PD-Rx Pharmaceuticals, Inc.

Application

ANDA075227

Marketing category

ANDA

Marketing start

1998-07-29

Marketing end

0000-00-00

Substance

NAPROXEN

Active strength

500 mg/1

Pharmacologic classes

Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record