Isosorbide dinitrate
- Product NDC
- 70771-1502
- 11-digit product format
- 707711502
- Labeler code
- 70771
- Product ID
- 70771-1502_3b64c3fa-5b13-4c53-96e1-221685297680
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isosorbide dinitrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA213057
- Marketing category
- ANDA
- Marketing start
- 2019-11-25
- 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 | 197839, 197840, 206842, 314055, 381056 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70771-1502-0 | Isosorbide dinitrate | 1000 in 1 BOTTLE | TABLET | 1000 | | 3 |
| 70771-1502-1 | Isosorbide dinitrate | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70771-1502 | ISOSORBIDE DINITRATE TABLET [ZYDUS LIFESCIENCES LIMITED] | 3 | Current NDC, Legacy NDC, 2 package rows | 20231108_5b0db8af-bcf9-458f-b752-420130cba428.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 |
|---|
| 70771-1502-0 | 70771150200 | 1000 TABLET in 1 BOTTLE (70771-1502-0) | 1000 tablet | 2019-11-25 | 0000-00-00 | No | No | Current |
| 70771-1502-1 | 70771150201 | 100 TABLET in 1 BOTTLE (70771-1502-1) | 100 tablet | 2019-11-25 | 0000-00-00 | No | No | Current |