Misoprostol
- Product NDC
- 50268-555
- 11-digit product format
- 502680555
- Labeler code
- 50268
- Product ID
- 50268-555_47e7448c-f84c-4a4c-e063-6394a90ad262
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Misoprostol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA210201
- Marketing category
- ANDA
- Marketing start
- 2024-10-03
- Substance
- MISOPROSTOL
- Active strength
- 200 ug/1
- Pharmacologic classes
- Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Misoprostol
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MISOPROSTOL | 200 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0E43V0BB57 |
| Rxcui | 317128 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50268-555-60 | Misoprostol | 60 in 1 BOTTLE | TABLET | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50268-555 | MISOPROSTOL TABLET [AVPAK] | 1 | Current NDC, 1 package rows | 20241004_2396e9c0-3742-69cf-e063-6394a90adb13.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 |
|---|
| 50268-555-60 | 50268055560 | 60 TABLET in 1 BOTTLE (50268-555-60) | 60 tablet | 2024-10-03 | No | No | Historical |