Active ingredient
Ketorolac
188 finished FDA listings contain Ketorolac as their only active ingredient; 2 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- KETOROLAC, KETOROLAC TROMETHAMINE
- Dosage forms
- Injection, Injection, Solution, Solution, Solution/ Drops, Spray, Metered, Tablet, Tablet, Film Coated
- Routes
- Intramuscular, Intravenous, Nasal, Ophthalmic, Oral
- Manufacturers / labelers
- 63
- Strengths listed
- 10 mg/1 · 15 mg/ml · 15.75 mg/1 · 30 mg/ml · 4 mg/ml · 4.5 mg/ml · 5 mg/ml · 60 mg/2ml
- Brand names in FDA listings
- Acular, Acular Ls, Acuvail, Sprix, Toronova Ii Suik, Toronova Suik
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 35827
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 019700 | ABBVIE | 1992-11-09 | 1 |
| ANDA 074761 | MYLAN | 1997-05-16 | 1 |
| ANDA 074754 | TEVA | 1997-05-16 | 13 |
| ANDA 074802 | HOSPIRA | 1997-06-05 | 9 |
| ANDA 075784 | FRESENIUS KABI USA | 2002-01-11 | 12 |
| NDA 021528 | ABBVIE | 2003-05-30 | 3 |
| ANDA 075772 | HIKMA | 2004-07-21 | 3 |
| ANDA 078299 | ONESOURCE SPECIALTY | 2007-07-16 | 3 |
| ANDA 078737 | SUN PHARM | 2008-10-06 | 3 |
| NDA 022427 | ABBVIE | 2009-07-22 | 1 |
| ANDA 076583 | SANDOZ | 2009-11-05 | 4 |
| ANDA 078434 | CHARTWELL RX | 2009-11-05 | 2 |
| ANDA 076109 | APOTEX | 2009-11-05 | 3 |
| ANDA 090017 | SUN PHARM | 2009-11-05 | 3 |
| NDA 022382 | COSETTE | 2010-05-14 | 1 |
| ANDA 201155 | ONESOURCE SPECIALTY | 2014-08-04 | 3 |
| ANDA 203242 | FRESENIUS KABI USA | 2015-10-07 | 4 |
| ANDA 204216 | GLAND | 2016-11-01 | 26 |
| ANDA 209900 | BAXTER HLTHCARE CORP | 2017-09-15 | 4 |
| ANDA 210616 | CHARTWELL RX | 2018-08-16 | 1 |
| ANDA 205191 | EUGIA PHARMA | 2018-11-15 | 1 |
| ANDA 203410 | MICRO LABS LTD INDIA | 2019-04-05 | 4 |
| ANDA 211445 | NEPHRON | 2020-08-20 | 1 |
| ANDA 212939 | EUGIA PHARMA | 2020-10-20 | 3 |
| ANDA 205190 | EUGIA PHARMA | 2020-12-03 | 1 |
| ANDA 215788 | SENORES PHARMS | 2022-03-23 | 14 |
| ANDA 216651 | HETERO LABS LTD III | 2022-08-25 | 5 |
| ANDA 217038 | ZYDUS LIFESCIENCES | 2022-10-21 | 9 |
| ANDA 216407 | ATNAHS PHARMA US | 2022-10-21 | 1 |
| ANDA 214456 | ALEMBIC | 2022-11-02 | 11 |
| ANDA 216759 | BIONPHARMA | 2023-02-23 | 9 |
| ANDA 215745 | LEADING | 2023-02-23 | 2 |
| ANDA 217789 | CAPLIN | 2023-05-10 | 11 |
| ANDA 217166 | ASPIRO | 2023-06-20 | 3 |
| ANDA 218204 | CAPLIN | 2024-03-26 | 9 |
Official labeling on DailyMed
- KETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH 107, LLC] · version 10 · 2026-09-07
- KETOROLAC TROMETHAMINE INJECTION, SOLUTION [SPORTPHARM LLC] · version 3 · 2026-09-07
- KETOROLAC TROMETHAMINE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] · version 2 · 2026-09-03
- KETOROLAC TROMETHAMINE INJECTION, SOLUTION [REMEDYREPACK INC.] · version 3 · 2026-09-02
- KETOROLAC TROMETHAMINE INJECTION, SOLUTION [REMEDYREPACK INC.] · version 3 · 2026-09-02
- KETOROLAC TROMETHAMINE TABLET, FILM COATED [REMEDYREPACK INC.] · version 6 · 2026-08-31
- KETOROLAC TROMETHAMINE SOLUTION/ DROPS [REDPHARM DRUG] · version 1 · 2026-08-26
- KETOROLAC TROMETHAMINE TABLET, FILM COATED [SPORTPHARM LLC] · version 5 · 2026-08-19
- KETOROLAC TROMETHAMINE TABLET, FILM COATED [REMEDYREPACK INC.] · version 6 · 2026-08-07
- KETOROLAC TROMETHAMINE TABLET, FILM COATED [AMERISYN LLC] · version 1 · 2026-07-27
- KETOROLAC TROMETHAMINE INJECTION, SOLUTION [HOSPIRA, INC.] · version 36 · 2026-07-21
- KETOROLAC TROMETHAMINE SOLUTION/ DROPS [APOTEX CORP.] · version 14 · 2026-07-17
Showing the 12 most recent of 145 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.