ISOSORBIDE MONONITRATE
- Product NDC
- 67046-1446
- 11-digit product format
- 670461446
- Labeler code
- 67046
- Product ID
- 67046-1446_2d9988ef-55cb-3043-e063-6294a90a1851
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ISOSORBIDE MONONITRATE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA216557
- Marketing category
- ANDA
- Marketing start
- 2025-02-07
- 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 |
|---|
| 67046-1446-3 | 67046144603 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1446-3) | 2025-02-07 | No | No | Historical |