Medicine
Ketorolac 5 mg/mL ophthalmic solution
Ketorolac 5 mg/mL ophthalmic solution is a generic prescription medicine for ophthalmic use, made by 11 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
- 5 mg/mL
- Dosage form
- Ophthalmic solution
- Route
- Ophthalmic
- Packs
- 5 mL, 10 mL, 3 mL and 18 more
- Manufacturers
- Micro LabsIndiaSOLA PharmaceuticalsSportpharmBryant Ranch PrepackNuCare Pharmaceuticals,IncProficient RxSandozA-S Medication SolutionsDirect_RxPreferred Pharmaceuticals
- 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 November 2009
- Identifiers
- RxCUI 860107DailyMed set ID fc8ba956-4d3d-4f52-ac8e-89d52a480b48, b08a46f3-36c9-405d-a963-9739a5c87f9c, 92546f61-bbd8-430a-ac92-89dfbe8e2f29 +10NDC 63187-628, 70512-790, 68788-8549 +10Application ANDA078434, ANDA218204, ANDA203410 +1
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 |
|---|---|---|---|
| 5 mL in 1 bottle | 42571-137-25 | Micro LabsIndia | 3 June 2019 |
| 10 mL in 1 bottle | 42571-137-26 | Micro LabsIndia | 3 June 2019 |
| 3 mL in 1 bottle | 42571-137-31 | Micro LabsIndia | 3 June 2019 |
| 1 bottle in 1 carton / 5 mL in 1 bottle | 61314-126-05 | Sandoz | 5 November 2009 |
| 1 bottle in 1 carton / 10 mL in 1 bottle | 61314-126-10 | Sandoz | 5 November 2009 |
| 1 bottle, dropper in 1 carton / 3 mL in 1 bottle, dropper | 70512-790-03 | SOLA Pharmaceuticals | 15 April 2024 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 70512-790-05 | SOLA Pharmaceuticals | 15 April 2024 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 70512-790-10 | SOLA Pharmaceuticals | 15 April 2024 |
| 5 mL in 1 bottle | 68071-2252-5 | NuCare Pharmaceuticals,Inc | 31 August 2020 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 68071-2400-5 | NuCare Pharmaceuticals,Inc | 12 May 2021 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 63187-628-05 | Proficient Rx | 1 December 2018 |
| 5 mL in 1 bottle | 71205-296-05 | Proficient Rx | 1 July 2019 |
| 5 mL in 1 bottle, plastic | 50090-2746-0 | A-S Medication Solutions | 4 January 2017 |
| 5 mL in 1 bottle | 72162-2384-2 | Bryant Ranch Prepack | 3 June 2019 |
| 10 mL in 1 bottle | 72162-2384-4 | Bryant Ranch Prepack | 3 June 2019 |
| 5 mL in 1 bottle | 72189-335-05 | Direct Rx | 7 March 2022 |
| 5 mL in 1 bottle | 68788-8549-5 | Preferred Pharmaceuticals | 15 November 2023 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 67296-2210-1 | Redpharm Drug | 15 April 2024 |
| 3 mL in 1 bottle | 85766-301-03 | Sportpharm | 5 October 2026 |
| 5 mL in 1 bottle | 85766-301-05 | Sportpharm | 5 October 2026 |
| 10 mL in 1 bottle | 85766-301-10 | Sportpharm | 5 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
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 5 mg/mL ophthalmic solution 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.