Diclofenac Sodium and Misoprostol

Product NDC

69339-124

11-digit product format

693390124

Labeler code

69339

Product ID

69339-124_4f699505-4205-4430-8959-8e929b986112

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Diclofenac Sodium and Misoprostol

Dosage form

TABLET, DELAYED RELEASE

Route

ORAL

Labeler

Dash Pharmaceuticals LLC

Application

ANDA200540

Marketing category

ANDA

Marketing start

2015-01-23

Marketing end

2019-08-31

Substance

DICLOFENAC SODIUM; MISOPROSTOL

Active strength

75 mg/1; mg/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

0000-00-00

Current FDA listing

Historical FDA.report record