Isosorbide Dinitrate
- Product NDC
- 68682-192
- 11-digit product format
- 686820192
- Labeler code
- 68682
- Product ID
- 68682-192_723d9f78-9d77-4575-af27-1aa117e6b8d7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- isosorbide dinitrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Oceanside Pharmaceuticals
- Application
- NDA012093
- Marketing category
- NDA
- Marketing start
- 2020-03-02
- Substance
- ISOSORBIDE DINITRATE
- Active strength
- 40 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 |
|---|
| IA7306519N | ISOSORBIDE DINITRATE | 87-33-2 | ISOSORBIDE DINITRATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68682-192-01 | 68682019201 | 100 TABLET in 1 BOTTLE (68682-192-01) | 100 tablet | 2020-03-02 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Isosorbide Dinitrate Tablets | Oceanside Pharmaceuticals | Bausch Health Companies Inc. | 2020-03-02 | HUMAN PRESCRIPTION DRUG LABEL | 1 |