Isosorbide Dinitrate
- Product NDC
- 0904-6620
- 11-digit product format
- 009046620
- Labeler code
- 0904
- Product ID
- 0904-6620_43289136-625e-4671-b4c8-bb523c11b132
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isosorbide Dinitrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA088088
- Marketing category
- ANDA
- Marketing start
- 1983-04-26
- Substance
- ISOSORBIDE DINITRATE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Isosorbide Dinitrate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ISOSORBIDE DINITRATE | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | IA7306519N |
| Rxcui | 206842, 381056 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-6620-61 | Isosorbide Dinitrate | 100 in 1 CARTON | TABLET | 100 | | 7 |
| 0904-6620-61 | Isosorbide Dinitrate | 1 in 1 BLISTER PACK | TABLET | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6620 | ISOSORBIDE DINITRATE TABLET [MAJOR PHARMACEUTICALS] | 6 | Current NDC, Legacy NDC, 2 package rows | 20250110_6c4997e7-9ce6-46a6-a9c1-4bd3d76155eb.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 |
|---|
| 0904-6620-61 | 00904662061 | 100 BLISTER PACK in 1 CARTON (0904-6620-61) / 1 TABLET in 1 BLISTER PACK | 100 blister pack | 1983-04-26 | 0000-00-00 | No | No | Current |