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Altafluor 4 mg/2.5 mg per mL ophthalmic solution

Benoxinate and Fluorescein · Ophthalmic · Altaire Pharmaceuticals
Available on requestPrescription onlyUS FDA Cold chain

Altafluor 4 mg/2.5 mg per mL ophthalmic solution is a prescription medicine containing Benoxinate and Fluorescein for ophthalmic use, marketed by Altaire Pharmaceuticals, 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

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Cold chain

Store in refrigerator at 2° to 8°C (36° to 46°F). After opening, Altafluor…

Key facts

Active ingredient (INN)
Benoxinate and Fluorescein
Brand
Altafluor
Strength
4 mg/2.5 mg per mL
Dosage form
Ophthalmic solution
Route
Ophthalmic
Packs
5 mL
Marketing authorisation holder
Altaire Pharmaceuticals
Manufacturer
Altaire Pharmaceuticals
Origin register
US FDA, United States
Storage
Store in refrigerator at 2° to 8°C (36° to 46°F). After opening, Altafluor Benox can be stored up to one month if stored at room temperature or until the expiration date on the bottle if stored in refrigerated conditions.
Cold chain
Yes, shipped temperature controlled
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
1 March 2018
Identifiers
RxCUI 2099132, 2099522DailyMed set ID 54017304-e680-4129-b52a-69cb9810af76NDC 59390-218Application NDA208582

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

PackCodeLabelerMarketed since
5 mL in 1 bottle, dropper59390-218-05Altaire Pharmaceuticals1 March 2018

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 14 December 2017Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS 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 Benoxinate and Fluorescein

Clinical summary

Benoxinate and Fluorescein is a fixed-dose combination medicine indicated for ophthalmic procedures requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent. It is available as eye drops and ophthalmic solution. MedsAcross supplies Benoxinate and Fluorescein 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 Benoxinate and Fluorescein

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Altafluor 4 mg/2.5 mg per 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.