Isosorbide Dinitrate
- Product NDC
- 68682-192
- 11-digit product format
- 686820192
- Labeler code
- 68682
- Product ID
- 68682-192_723d9f78-9d77-4575-af27-1aa117e6b8d7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- isosorbide dinitrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Oceanside Pharmaceuticals
- Application
- NDA012093
- Marketing category
- NDA
- Marketing start
- 2020-03-02
- Substance
- ISOSORBIDE DINITRATE
- Active strength
- 40 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 | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | IA7306519N |
| Rxcui | 197840, 314055 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68682-192-01 | Isosorbide Dinitrate | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68682-192 | ISOSORBIDE DINITRATE TABLET [OCEANSIDE PHARMACEUTICALS] | 1 | Current NDC, Legacy NDC, 1 package rows | 20200617_723d9f78-9d77-4575-af27-1aa117e6b8d7.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 |
|---|
| 68682-192-01 | 68682019201 | 100 TABLET in 1 BOTTLE (68682-192-01) | 100 tablet | 2020-03-02 | 0000-00-00 | No | No | Current |