Diclofenac sodium

Product NDC
68788-8236
11-digit product format
687888236
Labeler code
68788
Product ID
68788-8236_b89a355b-3f93-4b65-b57b-fff5841f249c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium
Dosage form
GEL
Route
TOPICAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA206298
Marketing category
ANDA
Marketing start
2022-08-09
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
68788-8236-1687888236011 TUBE in 1 CARTON (68788-8236-1) / 100 g in 1 TUBE1 tube2022-08-09NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Diclofenac sodiumPreferred Pharmaceuticals Inc.2025-01-13HUMAN PRESCRIPTION DRUG LABEL4