Isosorbide Dinitrate
- Product NDC
- 0781-1695
- 11-digit product format
- 007811695
- Labeler code
- 0781
- Product ID
- 0781-1695_9c848a4f-2720-4c80-a0be-e49200cb10f9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isosorbide Dinitrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sandoz Inc.
- Application
- ANDA089367
- Marketing category
- ANDA
- Marketing start
- 1988-01-07
- 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, 314055, 381056 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 0781-1695-01 | 2022-08-09 | C162847 | 48780-1 | ab0e2407-2f15-f274-e053-dbdaa90a6471 | Isosorbide Dinitrate Tablets, USP (Oral) |
| 0781-1695-01 | 2022-08-09 | C162847 | 48780-1 | ab0e2407-2f15-f274-e053-dbdaa90a6471 | Isosorbide Dinitrate Tablets, USP (Oral) |
| 0781-1695-10 | 2022-08-09 | C162847 | 48780-1 | ab0e2407-2f15-f274-e053-dbdaa90a6471 | Isosorbide Dinitrate Tablets, USP (Oral) |
| 0781-1695-10 | 2022-08-09 | C162847 | 48780-1 | ab0e2407-2f15-f274-e053-dbdaa90a6471 | Isosorbide Dinitrate Tablets, USP (Oral) |
| 0781-1695-13 | 2022-08-09 | C162847 | 48780-1 | ab0e2407-2f15-f274-e053-dbdaa90a6471 | Isosorbide Dinitrate Tablets, USP (Oral) |
| 0781-1695-13 | 2022-08-09 | C162847 | 48780-1 | ab0e2407-2f15-f274-e053-dbdaa90a6471 | Isosorbide Dinitrate Tablets, USP (Oral) |
| 0781-1695-01 | 2022-07-29 | C162847 | 48780-1 | ab0e2407-2f15-f274-e053-dbdaa90a6471 | Isosorbide Dinitrate Tablets, USP (Oral) |
| 0781-1695-01 | 2022-07-29 | C162847 | 48780-1 | ab0e2407-2f15-f274-e053-dbdaa90a6471 | Isosorbide Dinitrate Tablets, USP (Oral) |
| 0781-1695-10 | 2022-07-29 | C162847 | 48780-1 | ab0e2407-2f15-f274-e053-dbdaa90a6471 | Isosorbide Dinitrate Tablets, USP (Oral) |
| 0781-1695-10 | 2022-07-29 | C162847 | 48780-1 | ab0e2407-2f15-f274-e053-dbdaa90a6471 | Isosorbide Dinitrate Tablets, USP (Oral) |
| 0781-1695-13 | 2022-07-29 | C162847 | 48780-1 | ab0e2407-2f15-f274-e053-dbdaa90a6471 | Isosorbide Dinitrate Tablets, USP (Oral) |
| 0781-1695-13 | 2022-07-29 | C162847 | 48780-1 | ab0e2407-2f15-f274-e053-dbdaa90a6471 | Isosorbide Dinitrate Tablets, USP (Oral) |
| 0781-1695-01 | 2020-08-03 | C162847 | 48780-1 | ab0e2407-2f15-f274-e053-dbdaa90a6471 | Isosorbide Dinitrate Tablets, USP (Oral) |
| 0781-1695-01 | 2020-08-03 | C162847 | 48780-1 | ab0e2407-2f15-f274-e053-dbdaa90a6471 | Isosorbide Dinitrate Tablets, USP (Oral) |
| 0781-1695-10 | 2020-08-03 | C162847 | 48780-1 | ab0e2407-2f15-f274-e053-dbdaa90a6471 | Isosorbide Dinitrate Tablets, USP (Oral) |
| 0781-1695-10 | 2020-08-03 | C162847 | 48780-1 | ab0e2407-2f15-f274-e053-dbdaa90a6471 | Isosorbide Dinitrate Tablets, USP (Oral) |
| 0781-1695-13 | 2020-08-03 | C162847 | 48780-1 | ab0e2407-2f15-f274-e053-dbdaa90a6471 | Isosorbide Dinitrate Tablets, USP (Oral) |
| 0781-1695-13 | 2020-08-03 | C162847 | 48780-1 | ab0e2407-2f15-f274-e053-dbdaa90a6471 | Isosorbide Dinitrate Tablets, USP (Oral) |
| 0781-1695-01 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-2f15-f274-e053-dbdaa90a6471 | Isosorbide Dinitrate Tablets, USP (Oral) |
| 0781-1695-01 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-2f15-f274-e053-dbdaa90a6471 | Isosorbide Dinitrate Tablets, USP (Oral) |
| 0781-1695-10 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-2f15-f274-e053-dbdaa90a6471 | Isosorbide Dinitrate Tablets, USP (Oral) |
| 0781-1695-10 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-2f15-f274-e053-dbdaa90a6471 | Isosorbide Dinitrate Tablets, USP (Oral) |
| 0781-1695-13 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-2f15-f274-e053-dbdaa90a6471 | Isosorbide Dinitrate Tablets, USP (Oral) |
| 0781-1695-13 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-2f15-f274-e053-dbdaa90a6471 | Isosorbide Dinitrate Tablets, USP (Oral) |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0781-1695-01 | Isosorbide Dinitrate | 100 in 1 BOTTLE | TABLET | 100 | | 19 |
| 0781-1695-10 | Isosorbide Dinitrate | 1000 in 1 BOTTLE | TABLET | 1000 | | 19 |
| 0781-1695-13 | Isosorbide Dinitrate | 10 in 1 BLISTER PACK | TABLET | 10 | | 19 |
| 0781-1695-13 | Isosorbide Dinitrate | 10 in 1 CARTON | TABLET | 10 | | 19 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0781-1695 | ISOSORBIDE DINITRATE TABLET [SANDOZ INC.] | 18 | Current NDC, Legacy NDC, 4 package rows | 20240504_71fdd147-a987-40b6-9f07-82d56525ceb8.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 |
|---|
| 0781-1695-01 | 00781169501 | 100 TABLET in 1 BOTTLE (0781-1695-01) | 100 tablet | 1988-01-07 | 0000-00-00 | No | No | Current |
| 0781-1695-10 | 00781169510 | 1000 TABLET in 1 BOTTLE (0781-1695-10) | 1000 tablet | 1988-01-07 | 0000-00-00 | No | No | Current |
| 0781-1695-13 | 00781169513 | 10 in 1 BLISTER PACK | | | | | | Historical |