FDA Orange Book
Generic for Apresoline
Apresoline contains hydralazine. 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 Apresoline is hydralazine. 16 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AP.
Run it in Rivvi
Map Apresoline and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Apresoline products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 20MG/ML | Discontinued | None | 8 | AP |
| tablet, oral | 100MG | Discontinued | None | 8 | AA |
| tablet, oral | 10MG | Discontinued | None | 6 | AA |
| tablet, oral | 25MG | Discontinued | None | 8 | AA |
| tablet, oral | 50MG | Discontinued | None | 8 | AA |
NDA 008303, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic hydralazine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PLIVA INC | 088467 | AA (A-rated, therapeutically equivalent) | May 1, 1984 | 25MG |
| PLIVA INC | 088468 | AA (A-rated, therapeutically equivalent) | May 1, 1984 | 50MG |
| PLIVA INC | 089098 | AA (A-rated, therapeutically equivalent) | December 18, 1985 | 100MG |
| PLIVA INC | 089097 | AA (A-rated, therapeutically equivalent) | December 18, 1985 | 10MG |
| AMERICAN REGENT INC | 040136 | AP (A-rated, therapeutically equivalent) | June 30, 1997 | 20MG/ML |
| FRESENIUS KABI USA LLC | 040388 | AP (A-rated, therapeutically equivalent) | March 13, 2001 | 20MG/ML |
| HETERO LABS LTD UNIT III | 040901 | AA (A-rated, therapeutically equivalent) | September 12, 2008 | 100MG, 10MG, 25MG, 50MG |
| RISING PHARMA HOLDINGS INC | 040730 | AP (A-rated, therapeutically equivalent) | April 21, 2009 | 20MG/ML |
| GLENMARK PHARMACEUTICALS LTD | 090527 | AA (A-rated, therapeutically equivalent) | May 29, 2009 | 100MG, 10MG, 25MG, 50MG |
| HERITAGE PHARMACEUTICALS INC | 040858 | AA (A-rated, therapeutically equivalent) | February 26, 2010 | 100MG, 10MG, 25MG, 50MG |
| ALKEM LABORATORIES LTD | 200737 | AA (A-rated, therapeutically equivalent) | December 7, 2012 | 100MG, 10MG, 25MG, 50MG |
| NAVINTA LLC | 202938 | AP (A-rated, therapeutically equivalent) | March 28, 2013 | 20MG/ML |
| STRIDES PHARMA GLOBAL PTE LTD | 200770 | AA (A-rated, therapeutically equivalent) | May 3, 2013 | 100MG, 25MG, 50MG |
| CADILA PHARMACEUTICALS LTD | 203845 | AA (A-rated, therapeutically equivalent) | September 18, 2014 | 100MG, 25MG, 50MG |
| SCIEGEN PHARMACEUTICALS INC | 205236 | AA (A-rated, therapeutically equivalent) | May 26, 2017 | 100MG, 10MG, 25MG, 50MG |
| HIKMA PHARMACEUTICALS USA INC | 213667 | AP (A-rated, therapeutically equivalent) | December 18, 2020 | 20MG/ML |
| EUGIA PHARMA SPECIALITIES LTD | 215147 | AP (A-rated, therapeutically equivalent) | February 13, 2023 | 20MG/ML |
| KINDOS PHARMACEUTICALS CO LTD | 217501 | AP (A-rated, therapeutically equivalent) | June 2, 2025 | 20MG/ML |
| BAXTER HEALTHCARE CORP | 219797 | AP (A-rated, therapeutically equivalent) | July 17, 2025 | 20MG/ML |
Questions
Is there a generic for Apresoline?
Yes. The generic name for Apresoline is hydralazine. 16 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AP.
What is the generic name for Apresoline?
The active ingredient in Apresoline is hydralazine, 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.