hydralazine hydrochloride and isosorbide dinitrate
hydralazine hydrochloride and isosorbide dinitrate is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand name including isosorbide dinitrate and hydralazine hydrochloride. Available dosage form: tablet, film coated.
Drug Details
- Generic Name
- hydralazine hydrochloride and isosorbide dinitrate
- Brand Names
- isosorbide dinitrate and hydralazine hydrochloride
- Application Number
- NDA020727
- Sponsor
- Wilshire Pharmaceuticals
- NDC Codes
- 2
- Dosage Forms
- TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- HYDRALAZINE HYDROCHLORIDE, ISOSORBIDE DINITRATE
Indications and Usage
1 INDICATIONS AND USAGE BiDil is a combination of isosorbide dinitrate, a nitrate vasodilator, and hydralazine hydrochloride, an arteriolar vasodilator, indicated for: the treatment of heart failure as an adjunct therapy to standard therapy in self-identified black patients to improve survival, prolong time to hospitalization for heart failure and to improve patient-reported functional status ( 1.1 ) Limitations of use: There is little experience in patients with NYHA class IV heart failure ( 1.2 ) 1.1 Treatment of Heart Failure in Self-identified Black Patients BiDil is indicated for the treatment of heart failure as an adjunct to standard therapy in self-identified black patients to improve survival, to prolong time to hospitalization for heart failure, and to improve patient-reported functional status. 1.2 Limitations of Use There is little experience in patients with NYHA class IV heart failure.