Medicine
Ketorolac 5 mg/mL eye drops
Ketorolac 5 mg/mL eye drops is a generic prescription medicine for ophthalmic use, made by 8 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), excursions permitted between 15° and 30°C…
Key facts
- Active ingredient (INN)
- Ketorolac
- Brand
- Sold under the generic name
- Strength
- 5 mg/mL
- Dosage form
- Eye drops
- Route
- Ophthalmic
- Packs
- 1 bottle and 15 more
- Manufacturers
- Caplin SterilesIndiaSun Pharmaceutical IndustriesIndiaAurobindo PharmaIndiaLeading PharmaApotexNuCare Pharmaceuticals,IncProficient RxRedpharm Drug
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (59° and 86°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
- 7 December 2009
- Identifiers
- RxCUI 860107DailyMed set ID 2c76b8f9-5385-4c98-aebb-bdca8613d24b, 53cb9528-7640-1fd4-e063-6294a90a74ad, d9a186ba-74a9-b6d4-1109-1e045ba1763e +7NDC 47335-220, 47335-221, 67296-2253 +11Application ANDA090017, ANDA218204, ANDA076109 +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 |
|---|---|---|---|
| 1 bottle, dropper in 1 carton / 3 mL in 1 bottle, dropper | 65145-138-01 | Caplin SterilesIndia | 23 January 2025 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 65145-139-01 | Caplin SterilesIndia | 23 January 2025 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 65145-140-01 | Caplin SterilesIndia | 23 January 2025 |
| 1 bottle, dropper in 1 carton / 3 mL in 1 bottle, dropper | 47335-219-90 | Sun Pharmaceutical IndustriesIndia | 13 March 2018 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 47335-220-90 | Sun Pharmaceutical IndustriesIndia | 13 March 2018 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 47335-221-90 | Sun Pharmaceutical IndustriesIndia | 13 March 2018 |
| 1 bottle in 1 carton / 5 mL in 1 bottle | 65862-770-05 | Aurobindo PharmaIndia | 3 December 2020 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 60505-1003-1 | Apotex | 7 December 2009 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 60505-1003-2 | Apotex | 7 December 2009 |
| 1 bottle, dropper in 1 carton / 3 mL in 1 bottle, dropper | 69315-322-03 | Leading Pharma | 1 June 2024 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 69315-322-05 | Leading Pharma | 1 June 2024 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 69315-322-10 | Leading Pharma | 1 June 2024 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 68071-3684-5 | NuCare Pharmaceuticals | 18 September 2024 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 68071-3880-5 | NuCare Pharmaceuticals | 31 July 2025 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 67296-2253-1 | Redpharm Drug | 23 January 2025 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 67296-2318-5 | Redpharm Drug | 1 June 2024 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 63187-777-05 | Proficient Rx | 1 November 2016 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 63187-777-10 | Proficient Rx | 1 November 2016 |
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 5 mg/mL eye drops.
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 eye drops 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.