diclofenac sodium

Product NDC
71205-692
11-digit product format
712050692
Labeler code
71205
Product ID
71205-692_67e384c6-8476-4aad-b967-241335538d56
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium
Dosage form
GEL
Route
TOPICAL
Labeler
Proficient Rx LP
Application
ANDA210893
Marketing category
ANDA
Marketing start
2018-11-27
Substance
DICLOFENAC SODIUM
Active strength
30 mg/g
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
QTG126297QDICLOFENAC SODIUM15307-79-6DICLOFENAC SODIUM

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71205-692-00712050692001 TUBE in 1 CARTON (71205-692-00) / 100 g in 1 TUBE1 tube2022-08-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Diclofenac Sodium Gel, 3%Proficient Rx LP2022-08-01HUMAN PRESCRIPTION DRUG LABEL1