FDA Orange Book
Generic for Ranexa
Ranexa contains ranolazine. 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 Ranexa is ranolazine. 19 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Ranexa 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.
Ranexa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 1GM | Discontinued | None | 19 | AB |
| tablet, extended release, oral | 500MG | Discontinued | None | 19 | AB |
NDA 021526, held by MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG SA. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ranolazine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CHARTWELL RX SCIENCES LLC | 201046 | AB (A-rated, therapeutically equivalent) | July 29, 2013 | 1GM, 500MG |
| AJANTA PHARMA LTD | 210054 | AB (A-rated, therapeutically equivalent) | May 28, 2019 | 1GM, 500MG |
| SCIEGEN PHARMACEUTICALS INC | 211829 | AB (A-rated, therapeutically equivalent) | June 4, 2019 | 1GM, 500MG |
| GLENMARK PHARMACEUTICALS LTD | 211082 | AB (A-rated, therapeutically equivalent) | July 5, 2019 | 1GM, 500MG |
| CADILA HEALTHCARE LTD | 210188 | AB (A-rated, therapeutically equivalent) | August 19, 2019 | 1GM, 500MG |
| MANKIND PHARMA LTD | 212284 | AB (A-rated, therapeutically equivalent) | February 12, 2020 | 1GM, 500MG |
| QUAGEN PHARMACEUTICALS LLC | 212781 | AB (A-rated, therapeutically equivalent) | March 23, 2020 | 1GM, 500MG |
| SUNSHINE LAKE PHARMA CO LTD | 211865 | AB (A-rated, therapeutically equivalent) | March 23, 2020 | 1GM, 500MG |
| ALKEM LABORATORIES LTD | 209953 | AB (A-rated, therapeutically equivalent) | November 30, 2020 | 1GM, 500MG |
| RISING PHARMA HOLDINGS INC | 212889 | AB (A-rated, therapeutically equivalent) | January 28, 2021 | 1GM, 500MG |
| VKT PHARMA PRIVATE LTD | 214035 | AB (A-rated, therapeutically equivalent) | January 19, 2022 | 1GM, 500MG |
| PHARMAZONE | 213517 | AB (A-rated, therapeutically equivalent) | April 27, 2022 | 1GM, 500MG |
| HETERO LABS LTD UNIT III | 212788 | AB (A-rated, therapeutically equivalent) | May 5, 2022 | 1GM, 500MG |
| AUROBINDO PHARMA LTD | 209081 | AB (A-rated, therapeutically equivalent) | December 23, 2022 | 1GM, 500MG |
| UNICHEM LABORATORIES LTD | 213083 | AB (A-rated, therapeutically equivalent) | March 16, 2023 | 1GM, 500MG |
| PIRAMAL HEALTHCARE UK LTD | 213085 | AB (A-rated, therapeutically equivalent) | July 25, 2023 | 1GM, 500MG |
| NOVAST LABORATORIES LTD | 210668 | AB (A-rated, therapeutically equivalent) | September 27, 2023 | 1GM, 500MG |
| JUBILANT GENERICS LTD | 211361 | AB (A-rated, therapeutically equivalent) | April 15, 2025 | 1GM, 500MG |
| UMEDICA LABORATORIES PRIVATE LTD | 214551 | AB (A-rated, therapeutically equivalent) | August 5, 2026 | 1GM, 500MG |
Questions
Is there a generic for Ranexa?
Yes. The generic name for Ranexa is ranolazine. 19 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 Ranexa?
The active ingredient in Ranexa is ranolazine, 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.