Isosorbide Mononitrate is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Rpk Pharmaceuticals, Inc.. The primary component is Isosorbide Mononitrate.
| Product ID | 53002-1570_24d88976-1196-4818-8c89-5584d85f4609 |
| NDC | 53002-1570 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Isosorbide Mononitrate |
| Generic Name | Isosorbide Mononitrate |
| Dosage Form | Tablet, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-01-05 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA075522 |
| Labeler Name | RPK Pharmaceuticals, Inc. |
| Substance Name | ISOSORBIDE MONONITRATE |
| Active Ingredient Strength | 30 mg/1 |
| Pharm Classes | Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2018-10-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA075522 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-10-01 |
| Inactivation Date | 2020-01-31 |
| Ingredient | Strength |
|---|---|
| ISOSORBIDE MONONITRATE | 30 mg/1 |
| SPL SET ID: | dca5ffde-4b95-4f47-b368-c1ad04ec27b7 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0143-1333 | Isosorbide Mononitrate | Isosorbide Mononitrate |
| 0228-2620 | Isosorbide Mononitrate | Isosorbide Mononitrate |
| 0228-2631 | Isosorbide Mononitrate | Isosorbide Mononitrate |
| 0603-4110 | Isosorbide Mononitrate | Isosorbide Mononitrate |
| 0603-4111 | Isosorbide Mononitrate | Isosorbide Mononitrate |
| 0603-4112 | Isosorbide Mononitrate | Isosorbide Mononitrate |
| 0615-4544 | Isosorbide Mononitrate | Isosorbide mononitrate |
| 0615-4546 | Isosorbide Mononitrate | Isosorbide mononitrate |
| 0615-5549 | Isosorbide Mononitrate | Isosorbide Mononitrate |
| 0615-5550 | Isosorbide Mononitrate | Isosorbide Mononitrate |
| 0615-7756 | Isosorbide Mononitrate | Isosorbide Mononitrate |
| 0615-7757 | Isosorbide Mononitrate | Isosorbide Mononitrate |
| 0615-7767 | ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE |
| 0615-7768 | ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE |
| 0615-8043 | ISOSORBIDE MONONITRATE | isosorbide mononitrate |
| 0615-8044 | ISOSORBIDE MONONITRATE | isosorbide mononitrate |
| 0904-6449 | ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE |
| 0904-6450 | ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE |
| 0904-6451 | ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE |
| 10544-243 | ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE |
| 13668-104 | ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE |
| 13668-105 | ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE |
| 68071-1953 | Isosorbide Mononitrate | Isosorbide Mononitrate |
| 68071-1926 | isosorbide mononitrate | isosorbide mononitrate |
| 68071-3015 | ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE |
| 68071-3081 | Isosorbide Mononitrate | Isosorbide Mononitrate |
| 68071-3296 | Isosorbide Mononitrate | Isosorbide Mononitrate |
| 68071-3266 | isosorbide mononitrate | isosorbide mononitrate |
| 68071-4290 | Isosorbide Mononitrate | Isosorbide Mononitrate |
| 68084-591 | isosorbide mononitrate | isosorbide mononitrate |
| 68084-592 | isosorbide mononitrate | isosorbide mononitrate |
| 68151-1420 | isosorbide mononitrate | isosorbide mononitrate |
| 68151-0314 | isosorbide mononitrate | isosorbide mononitrate |
| 68382-651 | ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE |
| 68382-650 | ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE |
| 68382-652 | ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE |
| 68788-6863 | isosorbide mononitrate | isosorbide mononitrate |
| 70518-0009 | isosorbide mononitrate | isosorbide mononitrate |
| 70518-0214 | ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE |
| 70518-1080 | ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE |
| 70518-1485 | Isosorbide Mononitrate | Isosorbide Mononitrate |
| 70934-183 | Isosorbide Mononitrate | Isosorbide Mononitrate |
| 71335-0037 | Isosorbide Mononitrate | Isosorbide Mononitrate |
| 71335-0431 | Isosorbide Mononitrate | Isosorbide Mononitrate |
| 13668-106 | ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE |
| 21695-575 | isosorbide mononitrate | isosorbide mononitrate |
| 21695-777 | isosorbide mononitrate | isosorbide mononitrate |
| 21695-837 | isosorbide mononitrate | isosorbide mononitrate |
| 23155-628 | Isosorbide Mononitrate | Isosorbide Mononitrate |
| 23155-178 | Isosorbide Mononitrate | Isosorbide Mononitrate |