Naproxen Sodium

Product NDC

70518-0409

11-digit product format

705180409

Labeler code

70518

Product ID

70518-0409_848cf5d3-3d6d-a19c-e053-2991aa0af469

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Naproxen Sodium

Dosage form

TABLET

Route

ORAL

Labeler

REMEDYREPACK INC.

Application

ANDA078314

Marketing category

ANDA

Marketing start

2017-04-07

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

2020-12-31

Current FDA listing

Historical FDA.report record