Naproxen

Product NDC

49999-897

11-digit product format

499990897

Labeler code

49999

Product ID

49999-897_94b1b49f-32b5-4b63-b1c1-11a87ddb5ef8

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Naproxen

Dosage form

TABLET, DELAYED RELEASE

Route

ORAL

Labeler

Lake Erie Medical DBA Quality Care Products LLC

Application

ANDA075227

Marketing category

ANDA

Marketing start

2011-02-03

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