hydralazine hydrochloride

FDA Drug Profile — HYDRALAZINE HYDROCHLORIDE

hydralazine hydrochloride is listed in the FDA National Drug Code directory with 15 NDC codes, marketed under brand name including HYDRALAZINE HYDROCHLORIDE. Available dosage forms: tablet, film coated, tablet.

Drug Details

Generic Name
hydralazine hydrochloride
Brand Names
HYDRALAZINE HYDROCHLORIDE
Application Number
ANDA086242
Sponsor
PD-Rx Pharmaceuticals, Inc.
NDC Codes
15
Dosage Forms
TABLET, FILM COATED, TABLET
Routes
ORAL
Active Ingredients
HYDRALAZINE HYDROCHLORIDE

Indications and Usage

INDICATIONS & USAGE Essential hypertension, alone or as an adjunct.

Warnings

WARNINGS In a few patients hydrALAZINE may produce a clinical picture simulating systemic lupus erythematosus including glomerulonephritis. In such patients hydrALAZINE should be discontinued unless the benefit-to-risk determination requires continued antihypertensive therapy with this drug. Symptoms and signs usually regress when the drug is discontinued but residua have been detected many years later. Long-term treatment with steroids may be necessary. (See PRECAUTIONS, Laboratory Tests.)