Diclofenac sodium

Product NDC

45861-063

11-digit product format

458610063

Labeler code

45861

Product ID

45861-063_cc352589-8d6a-4b2b-b225-fbba5a2a4555

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

diclofenac sodium

Dosage form

GEL

Route

TOPICAL

Labeler

Pharmaceutica North America, Inc

Application

ANDA206298

Marketing category

ANDA

Marketing start

2016-04-28

Marketing end

0000-00-00

Substance

DICLOFENAC SODIUM

Active strength

30 mg/g

Pharmacologic classes

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

NDC exclude flag

E

Listing certified through

2018-12-31

Current FDA listing

Historical FDA.report record