naproxen

Product NDC

68071-3066

11-digit product format

680713066

Labeler code

68071

Product ID

68071-3066_4a643dcd-c15e-34a4-e054-00144ff8d46c

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

naproxen

Dosage form

TABLET

Route

ORAL

Labeler

NuCare Pharmaceuticals, Inc.

Application

ANDA091305

Marketing category

ANDA

Marketing start

2016-07-05

Marketing end

0000-00-00

Substance

NAPROXEN

Active strength

375 mg/1

Pharmacologic classes

Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record