Diclofenac sodium
- Product NDC
- 80425-0337
- 11-digit product format
- 804250337
- Labeler code
- 80425
- Product ID
- 80425-0337_2a9c0c91-2b36-4def-e063-6294a90a58ef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac sodium
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA212506
- Marketing category
- ANDA
- Marketing start
- 2023-05-19
- Substance
- DICLOFENAC SODIUM
- Active strength
- 20 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0337-1 | 80425033701 | 1 BOTTLE, PUMP in 1 CARTON (80425-0337-1) / 112 g in 1 BOTTLE, PUMP | 2023-05-19 | No | No | Historical |