Misoprostol
- Product NDC
- 82804-037
- 11-digit product format
- 828040037
- Labeler code
- 82804
- Product ID
- 82804-037_85410e16-d164-4666-9539-778e2b4dd138
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Misoprostol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA076095
- Marketing category
- ANDA
- Marketing start
- 2022-04-11
- 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
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 |
|---|
| 82804-037-10 | 82804003710 | 10 TABLET in 1 BOTTLE (82804-037-10) | 10 tablet | 2023-11-07 | No | No | Historical |
| 82804-037-20 | 82804003720 | 20 TABLET in 1 BOTTLE (82804-037-20) | 20 tablet | 2023-11-07 | No | No | Historical |
| 82804-037-30 | 82804003730 | 30 TABLET in 1 BOTTLE (82804-037-30) | 30 tablet | 2023-11-07 | No | No | Historical |
| 82804-037-60 | 82804003760 | 60 TABLET in 1 BOTTLE (82804-037-60) | 60 tablet | 2023-11-07 | No | No | Historical |
| 82804-037-90 | 82804003790 | 90 TABLET in 1 BOTTLE (82804-037-90) | 90 tablet | 2023-11-07 | No | No | Historical |