Medicine
Tetracaine 5 mg/mL ophthalmic solution
Tetracaine 5 mg/mL ophthalmic solution is a generic prescription medicine for ophthalmic use, made by 5 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 15° to 25°C (59° to 77°F). Protect from light.
Key facts
- Active ingredient (INN)
- Tetracaine
- Brand
- Sold under the generic name
- Strength
- 5 mg/mL
- Dosage form
- Ophthalmic solution
- Route
- Ophthalmic
- Packs
- 1 bottle, 12 blister pack, 4 mL and 4 more
- Manufacturers
- Somerset TherapeuticsSportpharmA-S Medication SolutionsAlcon LaboratoriesRemedyrepack
- Origin register
- US FDA, United States
- Storage
- Store at 15° to 25°C (59° to 77°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C05AD02 Tetracaine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 2 November 2016
- Identifiers
- RxCUI 1547771DailyMed set ID 23c40ef8-6338-46f8-aca9-1aa4f3b2207b, 90ffa320-652b-442f-97fa-6d618439db79, bab63a18-3069-48a1-896e-433725f1dbaf +2NDC 50090-2364, 85766-230, 85766-229 +4Application NDA208135, ANDA217227
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 in 1 carton / 5 mL in 1 bottle | 70069-596-01 | Somerset Therapeutics | 23 December 2024 |
| 1 bottle in 1 carton / 15 mL in 1 bottle | 70069-597-01 | Somerset Therapeutics | 23 December 2024 |
| 12 blister pack in 1 carton / 1 bottle, dropper in 1 blister pack / 4 mL in 1 bottle, dropper | 0065-0741-14 | Alcon Laboratories | 2 November 2016 |
| 1 bottle in 1 carton / 5 mL in 1 bottle | 85766-229-05 | Sportpharm | 3 July 2026 |
| 1 bottle in 1 carton / 15 mL in 1 bottle | 85766-230-15 | Sportpharm | 3 July 2026 |
| 4 mL in 1 bottle, dropper | 50090-2364-1 | A-S Medication Solutions | 23 September 2019 |
| 12 bottle, dropper in 1 carton / 4 mL in 1 bottle, dropper | 70518-4183-0 | Remedyrepack | 24 September 2024 |
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 29 February 2016 | 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 Tetracaine
Clinical summary
Tetracaine is an ester local anesthetic indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. It is available as ophthalmic solution and eye drops. MedsAcross supplies Tetracaine 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 TetracaineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Tetracaine Hydrochloride prescribing information (Alcon Laboratories) · U.S. National Library of Medicine, DailyMed
Need Tetracaine 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.