| Product NDC: | 0615-4546 |
| Proprietary Name: | Isosorbide Mononitrate |
| Non Proprietary Name: | Isosorbide mononitrate |
| Active Ingredient(s): | 30 mg/1 & nbsp; Isosorbide mononitrate |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED, EXTENDED RELEASE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0615-4546 |
| Labeler Name: | NCS HealthCare of KY, Inc dba Vangard Labs |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA076813 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20060330 |
| Package NDC: | 0615-4546-39 |
| Package Description: | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0615-4546-39) |
| NDC Code | 0615-4546-39 |
| Proprietary Name | Isosorbide Mononitrate |
| Package Description | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0615-4546-39) |
| Product NDC | 0615-4546 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Isosorbide mononitrate |
| Dosage Form Name | TABLET, FILM COATED, EXTENDED RELEASE |
| Route Name | ORAL |
| Start Marketing Date | 20060330 |
| Marketing Category Name | ANDA |
| Labeler Name | NCS HealthCare of KY, Inc dba Vangard Labs |
| Substance Name | ISOSORBIDE MONONITRATE |
| Strength Number | 30 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] |