ARTHROTEC

Product NDC

49999-987

11-digit product format

499990987

Labeler code

49999

Product ID

49999-987_58ee63d2-8ee3-491f-b7c6-e473160d13cf

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

diclofenac sodium and misoprostol

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

Application

NDA020607

Marketing category

NDA

Marketing start

2012-02-23

Marketing end

0000-00-00

Substance

DICLOFENAC SODIUM; MISOPROSTOL

Active strength

75 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