Naproxen

Product NDC

50436-6608

11-digit product format

504366608

Labeler code

50436

Product ID

50436-6608_c28cfc98-f1eb-470f-83d4-130e24bb689b

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Naproxen

Dosage form

TABLET

Route

ORAL

Labeler

Unit Dose Services

Application

ANDA078250

Marketing category

ANDA

Marketing start

2007-07-01

Marketing end

0000-00-00

Substance

NAPROXEN

Active strength

375 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