Drug

Who makes hydralazine hydrochloride and isosorbide dinitrate?

3 companies list hydralazine hydrochloride and isosorbide dinitrate as a human prescription drug, including under the names BiDil. Forms: tablet, film coated. Routes: oral.

Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology

Companies listing hydralazine hydrochloride and isosorbide dinitrate

CompanyFormsApplicationNDCsRegistered sites
Bryant Ranch PrepackUnited Statestablet, film coatedNDA AUTHORIZED GENERICNDA02072711
Azurity Pharmaceuticals, Inc.tablet, film coatedNDANDA02072710
Wilshire Pharmaceuticals, Inc.tablet, film coatedNDA AUTHORIZED GENERICNDA02072710
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Common questions

Who makes hydralazine hydrochloride and isosorbide dinitrate?
3 companies list hydralazine hydrochloride and isosorbide dinitrate as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, Azurity Pharmaceuticals, Inc., Wilshire Pharmaceuticals, Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.