ISOSORBIDE MONONITRATE
- Product NDC
- 55154-7291
- 11-digit product format
- 551547291
- Labeler code
- 55154
- Product ID
- 55154-7291_92197742-097e-45e9-991c-4ec077e3b507
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ISOSORBIDE MONONITRATE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA200270
- Marketing category
- ANDA
- Marketing start
- 2015-01-05
- Substance
- ISOSORBIDE MONONITRATE
- 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 MONONITRATE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ISOSORBIDE MONONITRATE | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | LX1OH63030 |
| Rxcui | 317110, 353538 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55154-7291-0 | ISOSORBIDE MONONITRATE | 10 in 1 BAG | TABLET, EXTENDED RELEASE | 10 | | 9 |
| 55154-7291-0 | ISOSORBIDE MONONITRATE | 1 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 1 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55154-7291 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [CARDINAL HEALTH 107, LLC] | 9 | Current NDC, Legacy NDC, 2 package rows | 20250507_72b8a20c-5833-4765-a4b5-9066eaec6ea1.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 |
|---|
| 55154-7291-0 | 55154729100 | 10 BLISTER PACK in 1 BAG (55154-7291-0) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 10 blister pack | 2015-01-05 | 0000-00-00 | No | No | Current |