Diclofenac Sodium
- Product NDC
- 80425-0338
- 11-digit product format
- 804250338
- Labeler code
- 80425
- Product ID
- 80425-0338_2a9ba8f4-6cf2-e827-e063-6394a90a0300
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium Topical
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA212351
- Marketing category
- ANDA
- Marketing start
- 2023-05-19
- 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 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 |
|---|
| 80425-0338-1 | 80425033801 | 1 TUBE in 1 CARTON (80425-0338-1) / 100 g in 1 TUBE | 1 tube | 2023-05-19 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Diclofenac Sodium Gel | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL | 3 |