Isosorbide dinitrate
- Product NDC
- 68001-562
- 11-digit product format
- 680010562
- Labeler code
- 68001
- Product ID
- 68001-562_224fb831-928b-b275-e063-6394a90ab649
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isosorbide dinitrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- BluePoint Laboratories
- Application
- ANDA213057
- Marketing category
- ANDA
- Marketing start
- 2023-08-05
- Substance
- ISOSORBIDE DINITRATE
- Active strength
- 30 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 | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | IA7306519N |
| Rxcui | 197839 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68001-562-00 | Isosorbide dinitrate | 100 in 1 BOTTLE | TABLET | 100 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68001-562 | ISOSORBIDE DINITRATE TABLET [BLUEPOINT LABORATORIES] | 4 | Current NDC, 1 package rows | 20240921_f1d52e9a-8de1-61db-e053-2a95a90aae50.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 |
|---|
| 68001-562-00 | 68001056200 | 100 TABLET in 1 BOTTLE (68001-562-00) | 100 tablet | 2023-08-05 | No | No | Current |