Diclofenac Sodium

Product NDC

53217-099

11-digit product format

532170099

Labeler code

53217

Product ID

53217-099_f5a52f1b-d5f3-4a37-b806-08f011644ce1

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Diclofenac Sodium

Dosage form

SOLUTION

Route

OPHTHALMIC

Labeler

Aidarex Pharmaceuticals LLC

Application

ANDA078031

Marketing category

ANDA

Marketing start

2017-11-10

Marketing end

0000-00-00

Substance

DICLOFENAC SODIUM

Active strength

1 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

2019-12-31

Current FDA listing

Historical FDA.report record