Diclofenac sodium

Product NDC

0591-2140

11-digit product format

005912140

Labeler code

0591

Product ID

0591-2140_4ac2ea30-0763-489d-abfa-4d0a4f0a0163

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Diclofenac sodium

Dosage form

SOLUTION

Route

TOPICAL

Labeler

Actavis Pharma, Inc.

Application

ANDA202852

Marketing category

ANDA

Marketing start

2015-04-06

Marketing end

0000-00-00

Substance

DICLOFENAC SODIUM

Active strength

16 mg/mL

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

2020-12-31

Current FDA listing

Historical FDA.report record