Diclofenac Sodium
- Product NDC
- 84386-120
- 11-digit product format
- 843860120
- Labeler code
- 84386
- Product ID
- 84386-120_e5c0863a-edb7-4f46-a396-c9b2d8785cf8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA204306
- Marketing category
- ANDA
- Marketing start
- 2025-10-15
- 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 |
|---|
| 84386-120-01 | 84386012001 | 1 TUBE in 1 CARTON (84386-120-01) / 100 g in 1 TUBE | 1 tube | 2025-10-15 | No | No | Historical |