ISOSORBIDE DINITRATE
- Product NDC
- 82804-108
- 11-digit product format
- 828040108
- Labeler code
- 82804
- Product ID
- 82804-108_cdaba447-a74a-4410-99e9-9c2d5fc76f21
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- isosorbide dinitrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA215723
- Marketing category
- ANDA
- Marketing start
- 2022-07-08
- Substance
- ISOSORBIDE DINITRATE
- Active strength
- 20 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ISOSORBIDE DINITRATE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ISOSORBIDE DINITRATE | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | IA7306519N |
| Rxcui | 206842 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82804-108-30 | ISOSORBIDE DINITRATE | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 82804-108-90 | ISOSORBIDE DINITRATE | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82804-108 | ISOSORBIDE DINITRATE TABLET [PROFICIENT RX LP] | 3 | Current NDC, 2 package rows | 20240713_1cf9b6dd-9d4e-4ea1-95ae-e9e46a3d1b20.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-108-30 | 82804010830 | 30 TABLET in 1 BOTTLE (82804-108-30) | 30 tablet | 2024-06-14 | No | No | Current |
| 82804-108-90 | 82804010890 | 90 TABLET in 1 BOTTLE (82804-108-90) | 90 tablet | 2024-07-05 | No | No | Current |