Medicine
Ketorolac 15 mg/1 mL injection
Ketorolac 15 mg/1 mL injection is a generic prescription medicine for intramuscular, intravenous use, made by 21 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20° to 25°C (68° to 77°F). Protect from light.
Key facts
- Active ingredient (INN)
- Ketorolac
- Brand
- Sold under the generic name
- Strength
- 15 mg/1 mL
- Dosage form
- Injection
- Route
- Intramuscular, intravenous
- Packs
- 25 vials of 1 mL, 10 vials of 1 mL, 1 vial of 1 mL and 27 more
- Manufacturers
- Camber PharmaceuticalsIndiaEugiaIndiaAlembic PharmaceuticalsIndiaCaplin SterilesIndiaGland PharmaIndiaGlenmark PharmaceuticalsIndiaSun Pharmaceutical IndustriesIndiaFresenius KabiA-S Medication SolutionsBaxter Healthcare
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- M01AB15 Ketorolac
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 5 September 2001
- Identifiers
- RxCUI 860092, 1665459, 1665461 +3DailyMed set ID 45966992-5af6-bf10-e063-6294a90af25b, 4596483b-990b-eaa4-e063-6394a90ac08f, ae70988f-4d5e-4930-9750-22742b44a5e0 +25NDC 83270-153, 83270-157, 85766-297 +23Application ANDA078299, ANDA201155, ANDA214456 +10
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 25 vial in 1 carton / 1 mL in 1 vial | 62332-599-25 | Alembic PharmaceuticalsIndia | 2 November 2022 |
| 10 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 31722-305-10 | Camber PharmaceuticalsIndia | 4 April 2024 |
| 25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 31722-305-25 | Camber PharmaceuticalsIndia | 20 June 2023 |
| 25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 65145-146-25 | Caplin SterilesIndia | 4 October 2024 |
| 1 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 55150-339-01 | EugiaIndia | 20 October 2020 |
| 25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 55150-339-25 | EugiaIndia | 20 October 2020 |
| 10 vial in 1 carton / 1 mL in 1 vial | 68083-132-10 | Gland PharmaIndia | 1 December 2016 |
| 25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 68462-755-25 | Glenmark PharmaceuticalsIndia | 19 October 2023 |
| 25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 47335-933-45 | Sun Pharmaceutical IndustriesIndia | 25 December 2022 |
| 25 vial, single-use in 1 tray / 1 mL in 1 vial, single-use | 63323-161-01 | Fresenius Kabi | 5 September 2001 |
| 25 vial, single-dose in 1 tray / 1 mL in 1 vial, single-dose | 63323-161-12 | Fresenius Kabi | 5 September 2001 |
| 25 vial, single-use in 1 tray / 1 mL in 1 vial, single-use | 63323-161-16 | Fresenius Kabi | 5 September 2001 |
| 24 blister pack in 1 carton / 1 syringe, glass in 1 blister pack / 1 mL in 1 syringe, glass | 76045-107-10 | Fresenius Kabi | 2 November 2015 |
| 10 vial in 1 carton / 1 mL in 1 vial | 0338-0069-10 | Baxter Healthcare | 30 November 2018 |
| 10 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 43066-049-10 | Baxter Healthcare | 19 May 2026 |
| 25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 83270-153-03 | Onesource Specialty Pharma | 30 September 2023 |
| 1 syringe, glass in 1 carton / 1 mL in 1 syringe, glass | 83270-157-01 | Onesource Specialty Pharma | 30 September 2023 |
| 25 vial in 1 carton / 1 mL in 1 vial | 72266-234-25 | Fosun Pharma | 23 June 2023 |
| 25 vial in 1 carton / 1 mL in 1 vial | 0641-6041-25 | Hikma Pharmaceuticals | 21 July 2004 |
| 25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 0409-3793-25 | Hospira | 30 December 2024 |
| 25 vial in 1 carton / 1 mL in 1 vial | 25021-700-01 | Sagent Pharmaceuticals | 5 September 2014 |
| 25 vial in 1 carton / 1 mL in 1 vial | 70512-842-25 | SOLA Pharmaceuticals | 1 July 2023 |
| 25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 50090-5609-0 | A-S Medication Solutions | 4 August 2021 |
| 25 vial in 1 carton / 1 mL in 1 vial | 50090-6807-0 | A-S Medication Solutions | 7 November 2023 |
| 10 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 72572-354-10 | Civica | 25 March 2023 |
| 25 vial in 1 carton / 1 mL in 1 vial | 72572-356-25 | Civica | 1 April 2026 |
| 5 vial, single-use in 1 bag / 1 mL in 1 vial, single-use | 55154-9366-5 | Cardinal Health | 5 September 2001 |
| 1 vial in 1 bag / 1 mL in 1 vial | 0404-9998-01 | Henry Schein | 5 April 2024 |
| 25 vial in 1 carton / 1 mL in 1 vial | 70518-4237-0 | Remedyrepack | 6 December 2024 |
| 25 vial in 1 carton / 1 mL in 1 vial | 85766-297-25 | Sportpharm | 22 October 2026 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 30 November 1989 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Ketorolac 15 mg/1 mL injection.
Other strengths and forms of Ketorolac
Clinical summary
Ketorolac is a cyclooxygenase inhibitor indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis, among other approved uses. It is available as injection, tablets and eye drops for intramuscular, intravenous and oral use. MedsAcross supplies Ketorolac for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about KetorolacFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Acular prescribing information (Allergan) · U.S. National Library of Medicine, DailyMed
Need Ketorolac 15 mg/1 mL injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.