Isosorbide Dinitrate
- Product NDC
- 68084-082
- 11-digit product format
- 680840082
- Labeler code
- 68084
- Product ID
- 68084-082_4133d711-2ce0-0891-e063-6294a90aeaab
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isosorbide Dinitrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA086925
- Marketing category
- ANDA
- Marketing start
- 2013-10-21
- 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 | 206842, 381056 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68084-082-01 | Isosorbide Dinitrate | 100 in 1 BOX, UNIT-DOSE | TABLET | 100 | | 10 |
| 68084-082-11 | Isosorbide Dinitrate | 1 in 1 BLISTER PACK | TABLET | 1 | | 10 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68084-082 | ISOSORBIDE DINITRATE TABLET [AMERICAN HEALTH PACKAGING] | 9 | Current NDC, Legacy NDC, 2 package rows | 20241215_5c94ecc0-fcaa-4af3-82c2-ff124f2df3e1.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 |
|---|
| 68084-082-01 | 68084008201 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-082-01) / 1 TABLET in 1 BLISTER PACK (68084-082-11) | 100 blister pack | 2013-10-21 | 0000-00-00 | No | No | Current |
| 68084-082-11 | 68084008211 | 1 in 1 BLISTER PACK | | | | | | Historical |