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BiDil
BiDil - 12948-001-01 - (Hydralazine hydrochloride and Isosorbide dinitrate)
Drug Information of BiDil
| Product NDC: | 12948-001 |
| Proprietary Name: | BiDil |
| Non Proprietary Name: | Hydralazine hydrochloride and Isosorbide dinitrate |
| Active Ingredient(s): | 37.5; 20 mg/1; mg/1 & nbsp; Hydralazine hydrochloride and Isosorbide dinitrate |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of BiDil
| Product NDC: | 12948-001 |
| Labeler Name: | Arbor Pharmaceuticals |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA020727 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20050623 |
Package Information of BiDil
| Package NDC: | 12948-001-01 |
| Package Description: | 12 TABLET, FILM COATED in 1 BOTTLE (12948-001-01) |
NDC Information of BiDil
| NDC Code | 12948-001-01 |
| Proprietary Name | BiDil |
| Package Description | 12 TABLET, FILM COATED in 1 BOTTLE (12948-001-01) |
| Product NDC | 12948-001 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Hydralazine hydrochloride and Isosorbide dinitrate |
| Dosage Form Name | TABLET, FILM COATED |
| Route Name | ORAL |
| Start Marketing Date | 20050623 |
| Marketing Category Name | NDA |
| Labeler Name | Arbor Pharmaceuticals |
| Substance Name | HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE |
| Strength Number | 37.5; 20 |
| Strength Unit | mg/1; mg/1 |
| Pharmaceutical Classes | Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC],Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] |
