Diclofenac Sodium

Product NDC

51079-224

11-digit product format

510790224

Labeler code

51079

Product ID

51079-224_9aee35a8-cb7f-08f6-e053-2a95a90af17d

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

diclofenac sodium

Dosage form

TABLET, DELAYED RELEASE

Route

ORAL

Labeler

Mylan Institutional Inc.

Application

ANDA075281

Marketing category

ANDA

Marketing start

2010-06-04

Marketing end

2020-03-31

Substance

DICLOFENAC SODIUM

Active strength

75 mg/1

Pharmacologic classes

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

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record