ISOSORBIDE DINITRATE
- Product NDC
- 72888-084
- 11-digit product format
- 728880084
- Labeler code
- 72888
- Product ID
- 72888-084_47a16566-2f2d-7df8-e063-6394a90a9012
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- isosorbide dinitrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Advagen Pharma Ltd
- Application
- ANDA215723
- Marketing category
- ANDA
- Marketing start
- 2022-07-08
- Substance
- ISOSORBIDE DINITRATE
- Active strength
- 30 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 | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | IA7306519N |
| Rxcui | 197839, 197840, 206842, 314055, 381056 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72888-084-00 | ISOSORBIDE DINITRATE | 1000 in 1 BOTTLE | TABLET | 1000 | | 3 |
| 72888-084-01 | ISOSORBIDE DINITRATE | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72888-084 | ISOSORBIDE DINITRATE (ISOSORBIDE DINITRATE) TABLET [ADVAGEN PHARMA LTD] | 1 | Current NDC, Legacy NDC, 2 package rows | 20220715_b166eb5b-bad8-4663-9c05-1c43539dab2c.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 |
|---|
| 72888-084-00 | 72888008400 | 1000 TABLET in 1 BOTTLE (72888-084-00) | 1000 tablet | 2022-07-08 | 0000-00-00 | No | No | Current |
| 72888-084-01 | 72888008401 | 100 TABLET in 1 BOTTLE (72888-084-01) | 100 tablet | 2022-07-08 | 0000-00-00 | No | No | Current |