Medicine
Proparacaine 5 mg/mL eye drops
Proparacaine 5 mg/mL eye drops is a generic prescription medicine for ophthalmic use, made by 9 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. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store bottles in carton until empty to protect from light.
Key facts
- Active ingredient (INN)
- Proparacaine
- Brand
- Sold under the generic name
- Strength
- 5 mg/mL
- Dosage form
- Eye drops
- Route
- Ophthalmic
- Packs
- 1 bottle, 15 mL and 9 more
- Manufacturers
- Lifestar PharmaIndiaMicro LabsIndiaSportpharmNuCare Pharmaceuticals,IncA-S Medication SolutionsBausch & LombRemedyrepackSandozSomerset Therapeutics
- Origin register
- US FDA, United States
- Storage
- Store bottles in carton until empty to protect from light.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- S01HA04 Proparacaine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 19 October 1973
- Identifiers
- RxCUI 1191013DailyMed set ID 4ae89863-233f-4015-92da-aad0f2a87677, 509fed7b-637b-418c-93cd-19f49ba8740c, df1af0e8-7d9d-4511-9d86-f0c31a5da2c2 +9NDC 85766-039, 85766-057, 42571-497 +9Application ANDA215816, ANDA040074, ANDA219294 +2
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 / 15 mL in 1 bottle, dropper | 70756-193-35 | Lifestar PharmaIndia | 21 May 2025 |
| 1 bottle in 1 carton / 15 mL in 1 bottle | 42571-497-57 | Micro LabsIndia | 1 February 2026 |
| 1 bottle, dropper in 1 carton / 15 mL in 1 bottle, dropper | 24208-730-06 | Bausch & Lomb | 29 September 1995 |
| 1 bottle in 1 carton / 15 mL in 1 bottle | 61314-016-01 | Sandoz | 5 June 2000 |
| 1 bottle in 1 carton / 15 mL in 1 bottle | 70069-601-01 | Somerset Therapeutics | 10 October 2024 |
| 1 bottle in 1 carton / 15 mL in 1 bottle | 85766-039-15 | Sportpharm | 7 August 2025 |
| 1 bottle in 1 carton / 15 mL in 1 bottle | 85766-056-15 | Sportpharm | 22 August 2025 |
| 1 bottle, dropper in 1 carton / 15 mL in 1 bottle, dropper | 85766-057-15 | Sportpharm | 22 August 2025 |
| 15 mL in 1 box | 68071-4368-5 | NuCare Pharmaceuticals,Inc | 30 March 2018 |
| 15 mL in 1 bottle | 68071-5139-5 | NuCare Pharmaceuticals,Inc | 23 December 2019 |
| 1 bottle, dropper in 1 carton / 15 mL in 1 bottle, dropper | 50090-1923-0 | A-S Medication Solutions | 15 July 2015 |
| 1 bottle in 1 carton / 15 mL in 1 bottle | 70518-3408-0 | Remedyrepack | 8 April 2022 |
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 1 July 1953 | 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 Proparacaine 5 mg/mL eye drops.
Clinical summary
Proparacaine is a local anesthetic indicated for procedures in which a topical ophthalmic anesthetic is indicated. It is available as eye drops for ophthalmic use. MedsAcross supplies Proparacaine 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 ProparacaineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Alcaine prescribing information (Alcon Laboratories) · U.S. National Library of Medicine, DailyMed
Need Proparacaine 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.