Diclofenac Sodium
- Product NDC
- 80425-0335
- 11-digit product format
- 804250335
- Labeler code
- 80425
- Product ID
- 80425-0335_2a9b9724-0261-e829-e063-6394a90a1c07
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA208198
- 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 |
| 144O8QL0L1 | DICLOFENAC | 15307-86-5 | Diclofenac |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0335-1 | 80425033501 | 1 BOTTLE in 1 CARTON (80425-0335-1) / 112 g in 1 BOTTLE | 1 bottle | 2023-05-19 | No | No | Historical |