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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diclofenac Sodium Misoprostol
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DICLOFENAC SODIUM | 75 mg/1 |
| MISOPROSTOL | 200 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0E43V0BB57, QTG126297Q |
| Rxcui | 857706, 1359105 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71205-866-00 | Diclofenac Sodium Misoprostol | 100 in 1 BOTTLE | TABLET, DELAYED RELEASE | 100 | | 3 |
| 71205-866-30 | Diclofenac Sodium Misoprostol | 30 in 1 BOTTLE | TABLET, DELAYED RELEASE | 30 | | 3 |
| 71205-866-55 | Diclofenac Sodium Misoprostol | 500 in 1 BOTTLE | TABLET, DELAYED RELEASE | 500 | | 3 |
| 71205-866-60 | Diclofenac Sodium Misoprostol | 60 in 1 BOTTLE | TABLET, DELAYED RELEASE | 60 | | 3 |
| 71205-866-64 | Diclofenac Sodium Misoprostol | 240 in 1 BOTTLE | TABLET, DELAYED RELEASE | 240 | | 3 |
| 71205-866-72 | Diclofenac Sodium Misoprostol | 120 in 1 BOTTLE | TABLET, DELAYED RELEASE | 120 | | 3 |
| 71205-866-90 | Diclofenac Sodium Misoprostol | 90 in 1 BOTTLE | TABLET, DELAYED RELEASE | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71205-866 | DICLOFENAC SODIUM MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 3 | Current NDC, Legacy NDC, 7 package rows | 20220722_33f7db0b-f049-4d2e-abf5-4db97222e175.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71205-866-00 | 71205086600 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-866-00) | 2022-03-07 | 0000-00-00 | No | No | Current |
| 71205-866-30 | 71205086630 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-866-30) | 2022-03-07 | 0000-00-00 | No | No | Current |
| 71205-866-55 | 71205086655 | 500 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-866-55) | 2022-03-07 | 0000-00-00 | No | No | Current |
| 71205-866-60 | 71205086660 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-866-60) | 2022-03-07 | 0000-00-00 | No | No | Current |
| 71205-866-64 | 71205086664 | 240 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-866-64) | 2022-03-07 | 0000-00-00 | No | No | Current |
| 71205-866-72 | 71205086672 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-866-72) | 2022-03-07 | 0000-00-00 | No | No | Current |
| 71205-866-90 | 71205086690 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-866-90) | 2022-03-07 | 0000-00-00 | No | No | Current |