ISOSORBIDE MONONITRATE
- Product NDC
- 59651-541
- 11-digit product format
- 596510541
- Labeler code
- 59651
- Product ID
- 59651-541_55810c9d-1140-40b8-a297-210a84afc05a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ISOSORBIDE MONONITRATE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA216557
- Marketing category
- ANDA
- Marketing start
- 2022-11-07
- 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, 317110, 353538 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-541-01 | 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 |
|---|
| 59651-541 | ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED] | 1 | Current NDC, Legacy NDC, 1 package rows | 20221111_55810c9d-1140-40b8-a297-210a84afc05a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59651-541-01 | 59651054101 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-541-01) | 2022-11-07 | 0000-00-00 | No | No | Current |