isosorbide mononitrate
- Product NDC
- 81665-103
- 11-digit product format
- 816650103
- Labeler code
- 81665
- Product ID
- 81665-103_dba5d0c5-88bc-4091-b882-43dddc70923e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- isosorbide mononitrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- OMNIVIUM PHARMACEUTICALS LLC.
- Application
- NDA020215
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2024-05-02
- Substance
- ISOSORBIDE MONONITRATE
- Active strength
- 20 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 | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | LX1OH63030 |
| Rxcui | 311192, 311197 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 81665-103-10 | isosorbide mononitrate | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 81665-103 | ISOSORBIDE MONONITRATE TABLET [OMNIVIUM PHARMACEUTICALS LLC.] | 1 | Current NDC, 1 package rows | 20240504_cdf01e14-778b-4b3f-8372-1c18f266fb98.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 81665-103-10 | 81665010310 | 100 TABLET in 1 BOTTLE (81665-103-10) | 100 tablet | 2024-05-02 | No | No | Current |