Isosorbide Mononitrate
- Product NDC
- 71610-825
- 11-digit product format
- 716100825
- Labeler code
- 71610
- Product ID
- 71610-825_17526f78-346d-b202-e063-6294a90a0c58
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isosorbide Mononitrate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA210918
- Marketing category
- ANDA
- Marketing start
- 2018-11-13
- Substance
- ISOSORBIDE MONONITRATE
- Active strength
- 30 mg/1
- Pharmacologic classes
- Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| LX1OH63030 | ISOSORBIDE MONONITRATE | 16051-77-7 | ISOSORBIDE MONONITRATE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-825-60 | 71610082560 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-825-60) | 2024-04-29 | No | No | Historical |