ARTHROTEC

Product NDC

55289-406

11-digit product format

552890406

Labeler code

55289

Product ID

55289-406_7c1f7133-88c4-afe7-e053-2991aa0a3f0c

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

diclofenac sodium and misoprostol

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

PD-Rx Pharmaceuticals, Inc.

Application

NDA020607

Marketing category

NDA

Marketing start

1997-12-24

Marketing end

0000-00-00

Substance

DICLOFENAC SODIUM; MISOPROSTOL

Active strength

50 mg/1; ug/1

Pharmacologic classes

Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record