DICLOENAC SODIUM and MISOPROSTOL
- Product NDC
- 80425-0273
- 11-digit product format
- 804250273
- Labeler code
- 80425
- Product ID
- 80425-0273_12141491-25f0-fbc5-e063-6394a90a1f23
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DICLOENAC SODIUM and MISOPROSTOL
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA204355
- Marketing category
- ANDA
- Marketing start
- 2023-02-16
- Substance
- DICLOFENAC SODIUM; MISOPROSTOL
- Active strength
- 75; 200 mg/1; ug/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]
- 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 |
| 0E43V0BB57 | MISOPROSTOL | 59122-46-2 | MISOPROSTOL |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0273-1 | 80425027301 | 60 TABLET in 1 BOTTLE (80425-0273-1) | 60 tablet | 2023-02-16 | No | No | Historical |