Diclofenac sodium

Product NDC
71205-538
11-digit product format
712050538
Labeler code
71205
Product ID
71205-538_cfac8933-0e28-48e0-92c1-c139cf32bdf3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium
Dosage form
GEL
Route
TOPICAL
Labeler
Proficient Rx LP
Application
ANDA206298
Marketing category
ANDA
Marketing start
2016-04-28
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
71205-538-00712050538001 TUBE in 1 CARTON (71205-538-00) / 100 g in 1 TUBE1 tube2021-02-24NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Diclofenac Sodium Gel, 3%Proficient Rx LP2023-01-01HUMAN PRESCRIPTION DRUG LABEL2