Isosorbide Mononitrate
- Product NDC
- 64950-250
- 11-digit product format
- 649500250
- Labeler code
- 64950
- Product ID
- 64950-250_74da603c-8c7e-4823-a2a7-82e6ae007531
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isosorbide Mononitrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Genus Lifesciences Inc.
- Application
- ANDA075037
- Marketing category
- ANDA
- Marketing start
- 2026-04-09
- Substance
- ISOSORBIDE MONONITRATE
- Active strength
- 10 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 Mononitrate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ISOSORBIDE MONONITRATE | 10 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 |
|---|
| 64950-250-01 | Isosorbide Mononitrate | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 64950-250-01 | 64950025001 | 100 TABLET in 1 BOTTLE (64950-250-01) | 100 tablet | 2026-04-09 | No | No | Current |