Misoprostol
- Product NDC
- 68071-3762
- 11-digit product format
- 680713762
- Labeler code
- 68071
- Product ID
- 68071-3762_2bae87bf-4da1-e8b7-e063-6394a90a2f90
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Misoprostol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA076095
- Marketing category
- ANDA
- Marketing start
- 2022-04-11
- Substance
- MISOPROSTOL
- Active strength
- 100 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 | 100 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0E43V0BB57 |
| Rxcui | 311727 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3762-3 | Misoprostol | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 68071-3762-9 | Misoprostol | 90 in 1 BOTTLE | TABLET | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3762 | MISOPROSTOL TABLET [NUCARE PHARMACEUTICALS, INC.] | 2 | Current NDC, 2 package rows | 20250116_2b5d0fcb-cc9c-5bb0-e063-6294a90ab1c8.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 |
|---|
| 68071-3762-3 | 68071376203 | 30 TABLET in 1 BOTTLE (68071-3762-3) | 30 tablet | 2025-01-10 | No | No | Current |
| 68071-3762-9 | 68071376209 | 90 TABLET in 1 BOTTLE (68071-3762-9) | 90 tablet | 2025-01-14 | No | No | Current |