DICLOFENAC SODIUM
- Product NDC
- 68071-3483
- 11-digit product format
- 680713483
- Labeler code
- 68071
- Product ID
- 68071-3483_1cd4c240-4f72-d49d-e063-6394a90a4e86
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- diclofenac sodium topical gel, 1%
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA210986
- Marketing category
- ANDA
- Marketing start
- 2020-09-14
- Substance
- DICLOFENAC SODIUM
- Active strength
- 10 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 UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| QTG126297Q | DICLOFENAC SODIUM | 15307-79-6 | DICLOFENAC SODIUM |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3483-1 | 68071348301 | 1 TUBE in 1 CARTON (68071-3483-1) / 100 g in 1 TUBE | 1 tube | 2023-08-17 | No | No | Historical |