Misoprostol
- Product NDC
- 60687-746
- 11-digit product format
- 606870746
- Labeler code
- 60687
- Product ID
- 60687-746_253ebbef-3f86-8958-e063-6394a90ad713
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Misoprostol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA076095
- Marketing category
- ANDA
- Marketing start
- 2023-04-01
- Substance
- MISOPROSTOL
- Active strength
- 200 ug/1
- Pharmacologic classes
- 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
- Misoprostol
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MISOPROSTOL | 200 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0E43V0BB57 |
| Rxcui | 311727, 317128 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60687-746-01 | Misoprostol | 100 in 1 CARTON | TABLET | 100 | | 2 |
| 60687-746-11 | Misoprostol | 1 in 1 BLISTER PACK | TABLET | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60687-746 | MISOPROSTOL TABLET [AMERICAN HEALTH PACKAGING] | 2 | Current NDC, 2 package rows | 20241027_9462d969-d3e5-4e7f-b556-bd647ab28c42.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 60687-746-01 | 60687074601 | 100 BLISTER PACK in 1 CARTON (60687-746-01) / 1 TABLET in 1 BLISTER PACK (60687-746-11) | 100 blister pack | 2023-04-01 | No | No | Current |
| 60687-746-11 | 60687074611 | 1 in 1 BLISTER PACK | | | | | Historical |