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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 0E43V0BB57 | MISOPROSTOL | 59122-46-2 | MISOPROSTOL |
Packages
| 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 | Historical |
| 68071-3762-9 | 68071376209 | 90 TABLET in 1 BOTTLE (68071-3762-9) | 90 tablet | 2025-01-14 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Misoprostol Tablets Rx only | NuCare Pharmaceuticals, Inc. | 2025-01-14 | HUMAN PRESCRIPTION DRUG LABEL | 2 |