ISOSORBIDE MONONITRATE
- Product NDC
- 50090-6798
- 11-digit product format
- 500906798
- Labeler code
- 50090
- Product ID
- 50090-6798_4ce3190c-27b9-48ad-a292-57a9c32dfd04
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ISOSORBIDE MONONITRATE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA216557
- Marketing category
- ANDA
- Marketing start
- 2022-11-07
- 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 |
|---|
| 50090-6798-0 | 50090679800 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6798-0) | 2023-11-02 | No | No | Historical |
| 50090-6798-1 | 50090679801 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6798-1) | 2023-11-02 | No | No | Historical |
| 50090-6798-2 | 50090679802 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6798-2) | 2023-11-02 | No | No | Historical |