Medicine
Omidria 11.52 mg/40.64 mg per 4 mL injection
Omidria 11.52 mg/40.64 mg per 4 mL injection is a prescription medicine containing Ketorolac and Phenylephrine for intraocular use, marketed by Rayner Surgical, 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 and Phenylephrine
- Brand
- Omidria
- Strength
- 11.52 mg/40.64 mg per 4 mL
- Dosage form
- Injection
- Route
- Intraocular
- Packs
- 1 vial of 4 mL, 4 vials of 4 mL
- Marketing authorisation holder
- Rayner Surgical
- Manufacturer
- Rayner Surgical
- 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
- S01FB51 Ketorolac and Phenylephrine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 July 2023
- Identifiers
- RxCUI 1540230, 1540235DailyMed set ID f25d7a42-da2a-7310-e053-2995a90a590fNDC 82604-600Application NDA205388
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 vial in 1 carton / 4 mL in 1 vial | 82604-600-00 | Rayner Surgical | 1 July 2023 |
| 4 vial in 1 carton / 4 mL in 1 vial | 82604-600-04 | Rayner Surgical | 1 July 2023 |
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.
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 and Phenylephrine
Clinical summary
Ketorolac and Phenylephrine is a fixed-dose combination of a cyclooxygenase inhibitor, a nonsteroidal anti-inflammatory drug and an alpha-1 adrenergic agonist indicated for maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain. MedsAcross supplies Ketorolac and Phenylephrine 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 Ketorolac and PhenylephrineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Omidria prescribing information (Omeros) · U.S. National Library of Medicine, DailyMed
- Omidria: European public assessment report (EPAR) · European Medicines Agency
Need Omidria 11.52 mg/40.64 mg per 4 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.