Quick answers
- What is Hydralazine hydrochloride and isosorbide dinitrate used for?
- The FDA-approved label (BiDil, Azurity Pharmaceuticals, Inc., November 30, 2025) says: “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 Limitations of use …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Hydralazine hydrochloride and isosorbide dinitrate have a boxed warning?
- No. None of the 6 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Hydralazine hydrochloride and isosorbide dinitrate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Hydralazine hydrochloride and isosorbide dinitrate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Hydralazine hydrochloride and isosorbide dinitrate?
- 6 companies list prescription products of Hydralazine hydrochloride and isosorbide dinitrate in the FDA NDC Directory, including Bryant Ranch Prepack, i3 Pharmaceuticals, LLC and A2A Integrated Pharmaceuticals.
What Hydralazine hydrochloride and isosorbide dinitrate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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 Limitations of use …
— FDA label: BiDil, Azurity Pharmaceuticals, Inc., effective November 30, 2025. Read the full label on DailyMed →
The FDA has 6 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 6 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 6 in the FDA NDC Directory |
| Brand names | Bidil |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| hydralazine hydrochloride 37.5 mg · isosorbide dinitrate 20 mg tablet | Generic | $0.6798 per tablet |
| hydralazine hydrochloride 37.5 mg · isosorbide dinitrate 20 mg tablet, film coated | Generic | $0.6798 per tablet |
| hydralazine hydrochloride 37.5 mg · isosorbide dinitrate 20 mg tablet, film coated | Brand: BiDil | $4.35 per tablet |
NADAC list of November 4, 2026; these prices took effect between February 18, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack1 product
- i3 Pharmaceuticals, LLC1 product
- A2A Integrated Pharmaceuticals1 product
- Ingenus Pharmaceuticals, LLC1 product
- Azurity Pharmaceuticals, Inc.1 product
- Wilshire Pharmaceuticals1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020727 BIDIL | Azurity | June 23, 2005 | 5, latest January 13, 2021 2021: Manufacturing (CMC) · 2019: Labeling · 2016: Manufacturing (CMC) |
Generic approvals (2)
- ANDA215586Ingenus Pharms LLC · April 6, 2022
- ANDA215988Pharmazone · January 17, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 905377, 905379 |
|---|---|
| SPL set ID of the quoted label | e1e63cd5-d1e4-4af5-bad5-1ad41ea46b00 |
| FDA labels (SPL) | 6 |
| FDA applications | NDA020727, 2 ANDA |
| Active ingredients (FDA) | HYDRALAZINE / ISOSORBIDE DINITRATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — BiDil, Azurity Pharmaceuticals, Inc., effective November 30, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →