ISOSORBIDE MONONITRATE
- Product NDC
- 59651-539
- 11-digit product format
- 596510539
- Labeler code
- 59651
- Product ID
- 59651-539_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
- 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 |
|---|---|
| ISOSORBIDE MONONITRATE | 30 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | LX1OH63030 |
| Rxcui | 311196, 317110, 353538 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| cc3f7505-fd5d-aab9-1128-173349f98a63 | Product name | 4 | 20230113 |
| f23201a1-1f10-4748-0041-3c03fbb37cfb | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59651-539-01 | ISOSORBIDE MONONITRATE | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | 1 | |
| 59651-539-05 | ISOSORBIDE MONONITRATE | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59651-539-01 | EA - Each | 59651-539 | 98d95a81-d8ad-40a4-ae44-0b7333504fb9 | 1 | 2023-03-13 |
| 59651-539-05 | EA - Each | 59651-539 | 3450a752-1b9f-47f5-8f65-53ccd406078d | 1 | 2023-03-13 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 311196 | isosorbide mononitrate 120 MG 24HR Extended Release Oral Tablet | PSN | 55810c9d-1140-40b8-a297-210a84afc05a | 1 |
| 317110 | isosorbide mononitrate 30 MG 24HR Extended Release Oral Tablet | PSN | 2d99893a-296a-134c-e063-6294a90ace3b | 1 |
| 317110 | isosorbide mononitrate 30 MG 24HR Extended Release Oral Tablet | PSN | 5fd86c08-18de-43a2-9962-ab6cbf57d6c0 | 1 |
| 317110 | isosorbide mononitrate 30 MG 24HR Extended Release Oral Tablet | PSN | 44a0f691-b826-4580-ab2d-b5d1cc99e283 | 1 |
| 317110 | isosorbide mononitrate 30 MG 24HR Extended Release Oral Tablet | PSN | 55810c9d-1140-40b8-a297-210a84afc05a | 1 |
| 353538 | isosorbide mononitrate 60 MG 24HR Extended Release Oral Tablet | PSN | 55810c9d-1140-40b8-a297-210a84afc05a | 1 |
| 311196 | 24 HR isosorbide mononitrate 120 MG Extended Release Oral Tablet | SCD | 55810c9d-1140-40b8-a297-210a84afc05a | 1 |
| 317110 | 24 HR isosorbide mononitrate 30 MG Extended Release Oral Tablet | SCD | 2d99893a-296a-134c-e063-6294a90ace3b | 1 |
| 317110 | 24 HR isosorbide mononitrate 30 MG Extended Release Oral Tablet | SCD | 5fd86c08-18de-43a2-9962-ab6cbf57d6c0 | 1 |
| 317110 | 24 HR isosorbide mononitrate 30 MG Extended Release Oral Tablet | SCD | 55810c9d-1140-40b8-a297-210a84afc05a | 1 |
| 317110 | 24 HR isosorbide mononitrate 30 MG Extended Release Oral Tablet | SCD | 44a0f691-b826-4580-ab2d-b5d1cc99e283 | 1 |
| 353538 | 24 HR isosorbide mononitrate 60 MG Extended Release Oral Tablet | SCD | 55810c9d-1140-40b8-a297-210a84afc05a | 1 |
| 311196 | isosorbide mononitrate 120 MG 24 HR Extended Release Oral Tablet | SY | 55810c9d-1140-40b8-a297-210a84afc05a | 1 |
| 317110 | isosorbide mononitrate 30 MG 24 HR Extended Release Oral Tablet | SY | 55810c9d-1140-40b8-a297-210a84afc05a | 1 |
| 317110 | isosorbide mononitrate 30 MG 24 HR Extended Release Oral Tablet | SY | 5fd86c08-18de-43a2-9962-ab6cbf57d6c0 | 1 |
| 317110 | isosorbide mononitrate 30 MG 24 HR Extended Release Oral Tablet | SY | 44a0f691-b826-4580-ab2d-b5d1cc99e283 | 1 |
| 317110 | isosorbide mononitrate 30 MG 24 HR Extended Release Oral Tablet | SY | 2d99893a-296a-134c-e063-6294a90ace3b | 1 |
| 353538 | isosorbide mononitrate 60 MG 24 HR Extended Release Oral Tablet | SY | 55810c9d-1140-40b8-a297-210a84afc05a | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 59651-539-01 | 59651053901 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-539-01) | 2022-11-07 | 0000-00-00 | No | No | Current |
| 59651-539-05 | 59651053905 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-539-05) | 2022-11-07 | 0000-00-00 | No | No | Current |