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, tablet, film coated.

Drug Details

Generic Name
hydralazine hydrochloride
Brand Names
HYDRALAZINE HYDROCHLORIDE
Application Number
ANDA203845
Sponsor
Cadila Pharmaceuticals Limited
NDC Codes
15
Dosage Forms
TABLET, TABLET, FILM COATED
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.)