ISOSORBIDE DINITRATE
- Product NDC
- 0615-8465
- 11-digit product format
- 006158465
- Labeler code
- 0615
- Product ID
- 0615-8465_e52655b8-2c52-4534-9f86-bb70ebff3321
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- isosorbide dinitrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA215723
- Marketing category
- ANDA
- Marketing start
- 2022-07-08
- Substance
- ISOSORBIDE DINITRATE
- 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 |
|---|
| IA7306519N | ISOSORBIDE DINITRATE | 87-33-2 | ISOSORBIDE DINITRATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0615-8465-39 | 00615846539 | 30 TABLET in 1 BLISTER PACK (0615-8465-39) | 30 tablet | 2023-05-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Isosorbide Dinitrate Tablets | NCS HealthCare of KY, LLC dba Vangard Labs | 2023-05-22 | HUMAN PRESCRIPTION DRUG LABEL | 1 |