Drug
Who makes isosorbide dinitrate and hydralazine hydrochloride?
3 companies list isosorbide dinitrate and hydralazine hydrochloride as a human prescription drug. Forms: tablet; 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 isosorbide dinitrate and hydralazine hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| A2A Integrated Pharmaceuticals, LLC | tablet, film coated | ANDAANDA215988 | 1 | 0 |
| Ingenus Pharmaceuticals, LLC | tablet | ANDAANDA215586 | 1 | 0 |
| i3 Pharmaceuticals, LLC | tablet, film coated | ANDAANDA215988 | 1 | 0 |
Enquiry
Common questions
- Who makes isosorbide dinitrate and hydralazine hydrochloride?
- 3 companies list isosorbide dinitrate and hydralazine hydrochloride as a human prescription drug in the openFDA NDC Directory, led by A2A Integrated Pharmaceuticals, LLC, Ingenus Pharmaceuticals, LLC, i3 Pharmaceuticals, LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic isosorbide dinitrate and hydralazine hydrochloride?
- 3 companies list isosorbide dinitrate and hydralazine hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics. Listing status is from the NDC Directory; it is not a statement of availability.