FDA Orange Book
Generic for Toradol
Toradol contains ketorolac. 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 Toradol is ketorolac. 22 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
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Toradol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 15MG/ML | Discontinued | None | 11 | AP |
| injectable, injection | 30MG/ML | Discontinued | None | 15 | AP |
| tablet, oral | 10MG | Discontinued | None | 8 | AB |
NDA 019698, 019645, held by ROCHE PALO ALTO LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ketorolac
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 074761 | AB (A-rated, therapeutically equivalent) | May 16, 1997 | 10MG |
| TEVA PHARMACEUTICALS USA INC | 074754 | AB (A-rated, therapeutically equivalent) | May 16, 1997 | 10MG |
| HOSPIRA INC | 074802 | AP (A-rated, therapeutically equivalent) | June 5, 1997 | 15MG/ML, 30MG/ML |
| FRESENIUS KABI USA LLC | 075784 | AP (A-rated, therapeutically equivalent) | January 11, 2002 | 15MG/ML, 30MG/ML |
| HIKMA PHARMACEUTICALS USA INC | 075772 | AP (A-rated, therapeutically equivalent) | July 21, 2004 | 15MG/ML, 30MG/ML |
| SANDOZ INC | 076271 | AP (A-rated, therapeutically equivalent) | October 6, 2004 | 30MG/ML |
| APOTEX INC | 077942 | AP (A-rated, therapeutically equivalent) | March 27, 2007 | 15MG/ML, 30MG/ML |
| SAGENT PHARMACEUTICALS INC | 091065 | AP (A-rated, therapeutically equivalent) | November 27, 2013 | 15MG/ML, 30MG/ML |
| FRESENIUS KABI USA LLC | 203242 | AP (A-rated, therapeutically equivalent) | October 7, 2015 | 30MG/ML |
| GLAND PHARMA LTD | 204216 | AP (A-rated, therapeutically equivalent) | November 1, 2016 | 15MG/ML, 30MG/ML |
| BAXTER HEALTHCARE CORP | 209900 | AP (A-rated, therapeutically equivalent) | July 25, 2018 | 15MG/ML, 30MG/ML |
| CHARTWELL RX SCIENCES LLC | 210616 | AB (A-rated, therapeutically equivalent) | August 16, 2018 | 10MG |
| NEPHRON PHARMACEUTICALS CORPORATION | 211445 | AP (A-rated, therapeutically equivalent) | August 20, 2020 | 30MG/ML |
| PHARMAZONE | 215788 | AB (A-rated, therapeutically equivalent) | March 23, 2022 | 10MG |
| HETERO LABS LTD UNIT III | 216651 | AB (A-rated, therapeutically equivalent) | August 25, 2022 | 10MG |
| ZYDUS LIFESCIENCES GLOBAL FZE | 217038 | AB (A-rated, therapeutically equivalent) | October 21, 2022 | 10MG |
| ALEMBIC PHARMACEUTICALS LTD | 214456 | AP (A-rated, therapeutically equivalent) | November 2, 2022 | 15MG/ML, 30MG/ML |
| BIONPHARMA INC | 216759 | AB (A-rated, therapeutically equivalent) | February 23, 2023 | 10MG |
| LEADING PHARMA LLC | 215745 | AB (A-rated, therapeutically equivalent) | February 23, 2023 | 10MG |
| CAPLIN STERILES LTD | 217789 | AP (A-rated, therapeutically equivalent) | May 10, 2023 | 15MG/ML, 30MG/ML |
| ASPIRO PHARMA LTD | 217166 | AP (A-rated, therapeutically equivalent) | June 20, 2023 | 15MG/ML, 30MG/ML |
| SHANDONG NEW TIME PHARMACEUTICAL CO LTD | 218355 | AP (A-rated, therapeutically equivalent) | September 23, 2026 | 30MG/ML |
| ADAPTIS PHARMA PRIVATE LTD | 221041 | AP (A-rated, therapeutically equivalent) | September 25, 2026 | 15MG/ML, 30MG/ML |
Questions
Is there a generic for Toradol?
Yes. The generic name for Toradol is ketorolac. 22 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
What is the generic name for Toradol?
The active ingredient in Toradol is ketorolac, 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.