Isosorbide Dinitrate
- Product NDC
- 0143-1769
- 11-digit product format
- 001431769
- Labeler code
- 0143
- Product ID
- 0143-1769_9be99742-a98b-46d3-9447-81b45679fff9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isosorbide Dinitrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA088088
- Marketing category
- ANDA
- Marketing start
- 1978-12-01
- Substance
- ISOSORBIDE DINITRATE
- Active strength
- 5 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | IA7306519N |
| Rxcui | 206842, 314055, 381056 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0143-1769-01 | Isosorbide Dinitrate | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 31 |
| 0143-1769-10 | Isosorbide Dinitrate | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | | 31 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-1769 | ISOSORBIDE DINITRATE TABLET [HIKMA PHARMACEUTICALS USA INC.] | 30 | Current NDC, Legacy NDC, 2 package rows | 20231229_f0b9b320-0bf8-4342-b654-135ccb6755c2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0143-1769-01 | 00143176901 | 100 TABLET in 1 BOTTLE, PLASTIC (0143-1769-01) | 100 tablet | 1978-12-01 | 0000-00-00 | No | No | Current |
| 0143-1769-10 | 00143176910 | 1000 TABLET in 1 BOTTLE, PLASTIC (0143-1769-10) | 1000 tablet | 1978-12-01 | 0000-00-00 | No | No | Current |