ISOSORBIDE DINITRATE
- Product NDC
- 82804-117
- 11-digit product format
- 828040117
- Labeler code
- 82804
- Product ID
- 82804-117_33d14f59-3ae8-4414-b826-06274cf0f3d9
- 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
- 10 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | IA7306519N |
| Rxcui | 381056 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82804-117-90 | ISOSORBIDE DINITRATE | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82804-117 | ISOSORBIDE DINITRATE TABLET [PROFICIENT RX LP] | 1 | Current NDC, 1 package rows | 20240713_33d14f59-3ae8-4414-b826-06274cf0f3d9.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 |
|---|
| 82804-117-90 | 82804011790 | 90 TABLET in 1 BOTTLE (82804-117-90) | 90 tablet | 2024-07-11 | No | No | Current |