FDA Orange Book
Generic for BiDil
BiDil contains hydralazine and isosorbide dinitrate. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for BiDil is hydralazine and isosorbide dinitrate. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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BiDil products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 37.5MG;20MG | Marketed (Rx) | AB | 2 | AB |
NDA 020727, held by AZURITY PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic hydralazine and isosorbide dinitrate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| INGENUS PHARMACEUTICALS LLC | 215586 | AB (A-rated, therapeutically equivalent) | April 6, 2022 | 37.5MG;20MG |
| PHARMAZONE | 215988 | AB (A-rated, therapeutically equivalent) | January 17, 2024 | 37.5MG;20MG |
BiDil NDC codes
Questions
Is there a generic for BiDil?
Yes. The generic name for BiDil is hydralazine and isosorbide dinitrate. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for BiDil?
The active ingredient in BiDil is hydralazine and isosorbide dinitrate, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.