Naproxen

Product NDC

35356-682

11-digit product format

353560682

Labeler code

35356

Product ID

35356-682_21d1d7a2-aba9-4d20-b6d3-68669564ccb6

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Naproxen

Dosage form

TABLET

Route

ORAL

Labeler

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

Application

ANDA075927

Marketing category

ANDA

Marketing start

2010-02-18

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