Drug
Who makes ketorolac tromethamine?
60 companies list ketorolac tromethamine as a human prescription drug, including under the names ACULAR LS, ACUVAIL, Acular, Sprix, Toronova II SUIK, Toronova SUIK. Forms: injection; injection, solution; solution; solution/ drops; spray, metered; tablet; tablet, film coated. Routes: intramuscular, intravenous, nasal, ophthalmic, oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing ketorolac tromethamine
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| International Medication Systems, Ltd.United States | injection; injection, solution; solution; solution/ drops | ANDA, NDA AUTHORIZED GENERICANDA074754, ANDA076583, ANDA204216 | 12 | 3 |
| NuCare Pharmaceuticals,Inc.United States | solution; solution/ drops; tablet, film coated | ANDAANDA074754, ANDA076109, ANDA076583 | 8 | 1 |
| RemedyRepack, IncUnited States | injection, solution; tablet, film coated | ANDAANDA074754, ANDA204216, ANDA216759 | 7 | 1 |
| Sun Pharmaceutical Industries LimitedIndia | injection; solution/ drops | ANDAANDA078737, ANDA090017 | 6 | 13 |
| Fresenius Kabi USA, LLCUnited States | injection, solution | ANDAANDA075784, ANDA203242 | 6 | 6 |
| ONESOURCE SPECIALTY PHARMA LIMITEDIndia | injection | ANDAANDA078299, ANDA201155 | 6 | 3 |
| Bryant Ranch PrepackUnited States | solution; tablet, film coated | ANDAANDA074754, ANDA203410, ANDA215788 | 6 | 1 |
| CAPLIN STERILES LIMITEDIndia | injection, solution; solution/ drops | ANDAANDA217789, ANDA218204 | 6 | 1 |
| Medical Purchasing Solutions, LLCUnited States | injection; injection, solution | ANDAANDA075784, ANDA204216, ANDA214456 | 6 | 1 |
| Proficient Rx LPUnited States | injection, solution; solution; solution/ drops; tablet, film coated | ANDAANDA074754, ANDA076109, ANDA076583 | 6 | 1 |
| RedPharm DrugUnited States | solution; solution/ drops; tablet, film coated | ANDAANDA215788, ANDA216759, ANDA217038 | 6 | 1 |
| Cardinal Health 418, Inc.United States | injection, solution | ANDAANDA074802, ANDA075784 | 5 | 34 |
| Baxter Healthcare CorporationUnited States | injection, solution | ANDAANDA209900, ANDA214456 | 5 | 16 |
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | injection, solution; tablet, film coated | ANDA, UNAPPROVED DRUG OTHERANDA074754, ANDA074802, ANDA204216 | 5 | 1 |
| HF Acquisition Co LLCUnited States | injection, solution | ANDAANDA074802, ANDA075784 | 5 | 1 |
| Camber Pharmaceuticals, Inc.United States | injection, solution; tablet, film coated | ANDAANDA216651, ANDA217166 | 4 | 1 |
| Civica, Inc. dba CivicaRxUnited States | injection, solution | ANDAANDA204216, ANDA209900 | 4 | 1 |
| Preferred Pharmaceuticals Inc.United States | solution; tablet, film coated | ANDAANDA203410, ANDA215788, ANDA216759 | 4 | 1 |
| SOLA Pharmaceuticals, LLC | injection; solution | ANDAANDA217789, ANDA218204 | 4 | 0 |
| Glenmark Pharmaceuticals Inc., USAIndia | injection, solution | ANDAANDA217789 | 3 | 9 |
| Alembic Pharmaceuticals LimitedIndia | injection | ANDAANDA214456 | 3 | 7 |
| Allergan, Inc.United States | solution/ drops | NDANDA019700, NDA021528, NDA022427 | 3 | 7 |
| Hospira, Inc.United States | injection, solution | ANDAANDA074802 | 3 | 7 |
| GLAND PHARMA LIMITEDIndia | injection, solution | ANDAANDA204216 | 3 | 4 |
| Hikma Pharmaceuticals USA Inc.United States | injection | ANDAANDA075772 | 3 | 4 |
| Direct RxUnited States | injection, solution; solution; tablet, film coated | ANDAANDA203410, ANDA204216, ANDA216759 | 3 | 1 |
| Henry Schein, Inc.United States | injection, solution | ANDAANDA204216 | 3 | 1 |
| Advanced Rx of Tennessee, LLC | injection, solution; tablet, film coated | ANDA, UNAPPROVED DRUG OTHERANDA216651 | 3 | 0 |
| Eugia US LLC | injection, solution | ANDAANDA212939 | 3 | 0 |
| Fosun Pharma USA Inc. | injection, solution | ANDAANDA204216 | 3 | 0 |
| Northstar Rx, LLC, | injection, solution | ANDAANDA217789 | 3 | 0 |
| Sportpharm LLC | injection; injection, solution; tablet, film coated | ANDAANDA074754, ANDA204216, ANDA214456 | 3 | 0 |
| Aurobindo Pharma LimitedIndia | solution/ drops | ANDAANDA205190, ANDA205191 | 2 | 6 |
| ProPharma Distribution, LLC.United States | injection, solution | ANDAANDA204216 | 2 | 3 |
| ADVANCED RX PHARMACY OF TENNESSEE LLCUnited States | tablet, film coated | ANDAANDA074754, ANDA215788 | 2 | 1 |
| Leading Pharma, LLCUnited States | solution/ drops; tablet, film coated | ANDAANDA215745, ANDA218204 | 2 | 1 |
| Northwind Health Company, LLCUnited States | tablet, film coated | ANDAANDA074754, ANDA215788 | 2 | 1 |
| PD-Rx Pharmaceuticals Inc.United States | tablet, film coated | ANDAANDA074754, ANDA215745 | 2 | 1 |
| Sagent Pharmaceuticals | injection, solution | ANDAANDA204216 | 2 | 0 |
| Dr. Reddy's Laboratories LimitedIndia | tablet, film coated | ANDAANDA215788 | 1 | 15 |
| Zydus Lifesciences LimitedIndia | tablet, film coated | ANDAANDA217038 | 1 | 12 |
| Apotex Inc.Canada | solution/ drops | ANDAANDA076109 | 1 | 6 |
| Micro Labs LimitedIndia | solution | ANDAANDA203410 | 1 | 5 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet, film coated | ANDAANDA074754 | 1 | 5 |
| Sandoz Industrial Products S.AAustria | solution | ANDAANDA076583 | 1 | 5 |
| Pacific Medical Industries LtdUnited States | solution/ drops | NDA AUTHORIZED GENERICNDA021528 | 1 | 4 |
| Ajanta Pharma LimitedIndia | tablet, film coated | ANDAANDA215788 | 1 | 2 |
| Bionpharma Inc.India | tablet, film coated | ANDAANDA216759 | 1 | 1 |
| Golden State Medical Supply Inc.United States | tablet, film coated | ANDAANDA215788 | 1 | 1 |
| St. Mary's Medical Park PharmacyUnited States | tablet, film coated | ANDAANDA216759 | 1 | 1 |
| Zydus Pharmaceuticals USA Inc.India | tablet, film coated | ANDAANDA217038 | 1 | 1 |
| ATNAHS PHARMA US LIMITED | tablet | ANDAANDA216407 | 1 | 0 |
| Amerisyn, LLC | tablet, film coated | ANDAANDA215788 | 1 | 0 |
| Amici Pharmaceuticals, LLC. | tablet, film coated | ANDAANDA215788 | 1 | 0 |
| Chartwell RX, LLC. | tablet | ANDAANDA210616 | 1 | 0 |
| Injecta Medcial LLC | tablet, film coated | ANDAANDA216651 | 1 | 0 |
| MAJOR Pharmaceuticals Inc. | tablet, film coated | ANDAANDA215788 | 1 | 0 |
| Mylan Pharmaceuticals, Inc. | tablet, film coated | ANDAANDA074761 | 1 | 0 |
| Nephron Pharmaceuticals Corporation | injection | ANDAANDA211445 | 1 | 0 |
| Zyla Life Sciences US Inc. | spray, metered | NDANDA022382 | 1 | 0 |
Bulk ingredient listings
- Professional Compounding Centers of America dba PCCAUnited States · 2 NDC
- Vasudha Pharma Chem LimitedIndia · 2 NDC
- Dr. Reddy's Laboratories LimitedIndia · 1 NDC
- Fagron Services B.V.Netherlands · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- QUIMICA SINTETICA SASpain · 1 NDC
- SCL Lifesciences LimitedIndia · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
- Symed Labs Limited · 1 NDC
- Viyash Scientific LimitedIndia · 1 NDC
Orange Book patents
5 unexpired patents list ketorolac tromethamine as the active ingredient, expiring between May 2027 and Aug 2029. Application holder: ABBVIE INC.
Enquiry
Common questions
- Who makes ketorolac tromethamine?
- 60 companies list ketorolac tromethamine as a human prescription drug in the openFDA NDC Directory, led by International Medication Systems, Ltd., NuCare Pharmaceuticals,Inc., RemedyRepack, Inc, Sun Pharmaceutical Industries Limited, Fresenius Kabi USA, LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic ACULAR LS?
- 57 companies list ketorolac tromethamine under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies ketorolac tromethamine active ingredient?
- 12 companies list ketorolac tromethamine as a bulk ingredient, including Professional Compounding Centers of America dba PCCA, Vasudha Pharma Chem Limited, Dr. Reddy's Laboratories Limited, Fagron Services B.V..