Diclofenac Sodium
- Product NDC
- 80425-0189
- 11-digit product format
- 804250189
- Labeler code
- 80425
- Product ID
- 80425-0189_2a99aae5-c906-7940-e063-6294a90a4146
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA075185
- Marketing category
- ANDA
- Marketing start
- 1998-11-13
- Substance
- DICLOFENAC SODIUM
- Active strength
- 75 mg/1
- 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 |
|---|
| 80425-0189-1 | 80425018901 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0189-1) | 1998-11-13 | No | No | Historical |
| 80425-0189-2 | 80425018902 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0189-2) | 1998-11-13 | No | No | Historical |
| 80425-0189-3 | 80425018903 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0189-3) | 1998-11-13 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Diclofenac Sodium DR Tablets | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL | 6 |