Diclofenac Sodium Misoprostol
- Product NDC
- 71205-866
- 11-digit product format
- 712050866
- Labeler code
- 71205
- Product ID
- 71205-866_47a851b9-3e7f-4271-a2b8-ce836579729b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium and Misoprostol
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA205143
- Marketing category
- ANDA
- Marketing start
- 2021-07-15
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 71205-866-00 | 71205086600 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-866-00) | 2022-03-07 | No | No | Historical |
| 71205-866-30 | 71205086630 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-866-30) | 2022-03-07 | No | No | Historical |
| 71205-866-55 | 71205086655 | 500 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-866-55) | 2022-03-07 | No | No | Historical |
| 71205-866-60 | 71205086660 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-866-60) | 2022-03-07 | No | No | Historical |
| 71205-866-64 | 71205086664 | 240 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-866-64) | 2022-03-07 | No | No | Historical |
| 71205-866-72 | 71205086672 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-866-72) | 2022-03-07 | No | No | Historical |
| 71205-866-90 | 71205086690 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-866-90) | 2022-03-07 | No | No | Historical |