Diclofenac Sodium and Misoprostol

Product NDC

63629-7034

11-digit product format

636297034

Labeler code

63629

Product ID

63629-7034_9ac42422-607a-4485-a49e-ed708d558a41

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Diclofenac Sodium and Misoprostol

Dosage form

TABLET, DELAYED RELEASE

Route

ORAL

Labeler

Bryant Ranch Prepack

Application

ANDA201089

Marketing category

ANDA

Marketing start

2012-11-01

Marketing end

0000-00-00

Substance

DICLOFENAC SODIUM; MISOPROSTOL

Active strength

50 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

2021-12-31

Current FDA listing

Historical FDA.report record