Prescription medicine
Hydralazine and isosorbide dinitrate Brand names: Bidil
Hydralazine and isosorbide dinitrate (Bidil) is a prescription medicine with an FDA approval on record since 2005. FDA's NDC Directory lists it from 3 generic labelers, and pharmacies paid $0.714 per isosorbide-hydralazine 20-37.5 mg tablet in the October 7, 2026 NADAC survey; its other strengths are brand-only, $4.35 per Bidil 20 mg-37.5 mg tablet.
- Generic listed
Check it at the source: the hydralazine and isosorbide dinitrate FDA label on DailyMed (effective November 30, 2025, Azurity Pharmaceuticals, Inc.); the NDA 20727 record on Drugs@FDA; every hydralazine and isosorbide dinitrate label on DailyMed.
Highlights of the record
FDA label of November 30, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageBiDil 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 ( 1.1 ) Limitations of use: There is little expe
Forms and strengths
- 20 mg / 37.5 mg
- 37.5 mg / 20 mg
Film-coated tablet; tablet.
On the market
- Earliest approval on file
- June 23, 2005 Bidil, Azurity; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first April 6, 2022; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 6 of which 3 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.714 per tablet Isosorbide-hydralazine 20-37.5 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 428 through July 30, 2026
What is hydralazine and isosorbide dinitrate used for?
From the label: indications and usageBiDil 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 ( 1.1 ) Limitations of use: There is little experience in patients with NYHA class IV heart failure ( 1.2 ) 1.1 Treatment of Heart Failure in Self-identified Black Patients BiDil is indicated for the treatment of heart failure as an adjunct to standard therapy in self-identified black patients to improve survival, to prolong time to hospitalization for heart failure, and to improve patient-reported functional status. 1.2 Limitations of Use There is little experience in patients with NYHA class IV heart failure. […]
Conditions named in the indications of hydralazine and isosorbide dinitrate's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Arteriolar Vasodilator and Nitrate Vasodilator.
Source: FDA drug label (BiDil), Azurity Pharmaceuticals, Inc., effective November 30, 2025 (SPL set e1e63cd5-d1e4-4af5-bad5-1ad41ea46b00), via openFDA; the full label on DailyMed
Is there a generic for hydralazine and isosorbide dinitrate (Bidil)?
The FDA approved the first generic hydralazine and isosorbide dinitrate on April 6, 2022. 2 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists hydralazine and isosorbide dinitrate from 3 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2005 earliest approval on file
- 2022 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for hydralazine and isosorbide dinitrate (Bidil)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.714 per Isosorbide-hydralazine 20-37.5 mg tablet, down 2% from $0.731 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Isosorbide-hydralazine 20-37.5 mg tablet (generic)
- Bidil 20 mg-37.5 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Isosorbide-hydralazine 20-37.5 mg tablet | Generic | $0.714 per tablet | $21.41 | -2% |
| Bidil 20 mg-37.5 mg tablet | Brand | $4.35 per tablet | $130.36 | no change |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the hydralazine and isosorbide dinitrate label say about other medicines?
The hydralazine and isosorbide dinitrate label names 6 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Avanafil | contraindications | Do not use BiDil in patients who are taking PDE-5 inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil. |
| Pyridoxine | warnings and precautions | May be treated with Pyridoxine |
| Riociguat | contraindications | Patients who are allergic to organic nitrates ( 4 ) Use of phosphodiesterase type 5 (PDE5) inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil, or soluble guanylate cyclase (sGC) stimulator (riociguat). |
| Sildenafil | contraindications | Do not use BiDil in patients who are taking PDE-5 inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil. |
| Tadalafil | contraindications | Do not use BiDil in patients who are taking PDE-5 inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil. |
| Vardenafil | contraindications | Do not use BiDil in patients who are taking PDE-5 inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil. |
Check hydralazine and isosorbide dinitrate against other medicines
Source: FDA drug label (BiDil), Azurity Pharmaceuticals, Inc., effective November 30, 2025 (SPL set e1e63cd5-d1e4-4af5-bad5-1ad41ea46b00), via openFDA; the full label on DailyMed
What do FAERS reports show for hydralazine and isosorbide dinitrate?
The FDA Adverse Event Reporting System holds 428 reports that list hydralazine and isosorbide dinitrate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 66 are coded as a death and 168 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as hydralazine and isosorbide dinitrate?
16 other medicines are given the same way (oral) and in the same FDA class as hydralazine and isosorbide dinitrate or labeled mainly for the same use (heart failure), the same class first. Heart failure lists all 37 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Carvedilol | Heart failure | 41 labelers | $0.0179 per tablet 6.25 mg tablet | No current entry |
| Spironolactone | Heart failure | 38 labelers | $0.0426 per tablet 25 mg tablet | A presentation being discontinued |
| Hydrochlorothiazide | Heart failure | 44 labelers | $0.0115 per tablet 25 mg tablet | A presentation being discontinued |
| Furosemide | Heart failure | 33 labelers | $0.026 per tablet 20 mg tablet | In shortage |
| Sacubitril and valsartan | Heart failure | 27 labelers | $0.533 per unit 49-51 mg | No current entry |
| Bumetanide | Heart failure | 24 labelers | $0.108 per tablet 1 mg tablet | Resolved |
| Digoxin | Heart failure | 21 labelers | $0.133 per tablet 125 mcg tablet | No current entry |
| Ivabradine | Heart failure | 11 labelers | $0.761 per tablet 5 mg tablet | A presentation being discontinued |
Every medicine labeled for the same conditions as hydralazine and isosorbide dinitrate
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to hydralazine and isosorbide dinitrate
- 16 medicines for the same use
- Other arteriolar vasodilators
- the pharmacologic class, with prices and generics
- Hydralazine and isosorbide dinitrate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other