Naprelan

Product NDC

59630-850

11-digit product format

596300850

Labeler code

59630

Product ID

59630-850_00ea44c7-97e5-426f-b0f2-8884e8bfa7dc

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Naproxen Sodium

Dosage form

TABLET, FILM COATED, EXTENDED RELEASE

Route

ORAL

Labeler

Shionogi Inc.

Application

NDA020353

Marketing category

NDA

Marketing start

1996-04-01

Marketing end

0000-00-00

Substance

NAPROXEN SODIUM

Active strength

500 mg/1

Pharmacologic classes

Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]

NDC exclude flag

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record