Isosorbide Mononitrate
- Product NDC
- 42799-960
- 11-digit product format
- 427990960
- Labeler code
- 42799
- Product ID
- 42799-960_7443a5b6-6153-4227-870c-3c710f1f2174
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isosorbide Mononitrate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Edenbridge Pharmaceuticals LLC.
- Application
- ANDA210822
- Marketing category
- ANDA
- Marketing start
- 2018-11-15
- Substance
- ISOSORBIDE MONONITRATE
- Active strength
- 120 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 | 120 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | LX1OH63030 |
| Rxcui | 311196 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42799-960-01 | Isosorbide Mononitrate | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42799-960 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [EDENBRIDGE PHARMACEUTICALS LLC.] | 1 | Current NDC | 20230629_0e3c4461-2e04-481f-a9e5-29f21cc71ec5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 42799-960-01 | 42799096001 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42799-960-01) | 2023-07-01 | No | No | Current |