Naproxen Sodium

Product NDC

68071-3054

11-digit product format

680713054

Labeler code

68071

Product ID

68071-3054_4a6403ad-fa53-2b4a-e054-00144ff8d46c

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Naproxen Sodium

Dosage form

TABLET

Route

ORAL

Labeler

NuCare Pharmaceuticals, Inc.

Application

ANDA078314

Marketing category

ANDA

Marketing start

2007-08-01

Marketing end

0000-00-00

Substance

NAPROXEN SODIUM

Active strength

550 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