Diclofenac Sodium/Misoprostol
- Product NDC
- 42571-133
- 11-digit product format
- 425710133
- Labeler code
- 42571
- Product ID
- 42571-133_3afc5367-562f-b4a0-e063-6294a90a2560
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium/Misoprostol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Micro Labs Limited
- Application
- ANDA204355
- Marketing category
- ANDA
- Marketing start
- 2021-09-01
- Substance
- DICLOFENAC SODIUM; MISOPROSTOL
- Active strength
- 50; 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
- Brand name suffix
- DICLOFENAC-SODIUM-MISOPROSTOL
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DICLOFENAC SODIUM | 50 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 |
|---|
| 42571-133-29 | Diclofenac Sodium/MisoprostolDICLOFENAC-SODIUM-MISOPROSTOL | 60 in 1 CARTON | TABLET | 60 | | 9 |
| 42571-133-29 | Diclofenac Sodium/MisoprostolDICLOFENAC-SODIUM-MISOPROSTOL | 10 in 1 BLISTER PACK | TABLET | 10 | | 9 |
| 42571-133-30 | Diclofenac Sodium/MisoprostolDICLOFENAC-SODIUM-MISOPROSTOL | 30 in 1 BOTTLE | TABLET | 30 | | 9 |
| 42571-133-60 | Diclofenac Sodium/MisoprostolDICLOFENAC-SODIUM-MISOPROSTOL | 60 in 1 BOTTLE | TABLET | 60 | | 9 |
| 42571-133-90 | Diclofenac Sodium/MisoprostolDICLOFENAC-SODIUM-MISOPROSTOL | 90 in 1 BOTTLE | TABLET | 90 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42571-133 | DICLOFENAC SODIUM/MISOPROSTOL DICLOFENAC-SODIUM-MISOPROSTOL (DICLOFENAC SODIUM/MISOPROSTOL) TABLET [MICRO LABS LIMITED] | 8 | Current NDC, Legacy NDC, 5 package rows | 20241205_c61df58d-d6bb-4d3e-9ef8-60caa7d4e762.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42571-133-29 | 42571013329 | 60 BLISTER PACK in 1 CARTON (42571-133-29) / 10 TABLET in 1 BLISTER PACK | 60 blister pack | 2021-09-01 | 0000-00-00 | No | No | Current |
| 42571-133-30 | 42571013330 | 30 TABLET in 1 BOTTLE (42571-133-30) | 30 tablet | 2021-09-01 | 0000-00-00 | No | No | Current |
| 42571-133-60 | 42571013360 | 60 TABLET in 1 BOTTLE (42571-133-60) | 60 tablet | 2021-09-01 | 0000-00-00 | No | No | Current |
| 42571-133-90 | 42571013390 | 90 TABLET in 1 BOTTLE (42571-133-90) | 90 tablet | 2021-09-01 | 0000-00-00 | No | No | Current |