Medicine
Maxitrol 1 mg/3.5 mg/10000 units per mL ophthalmic suspension
Maxitrol 1 mg/3.5 mg/10000 units per mL ophthalmic suspension is a prescription medicine containing Dexamethasone, Neomycin and Polymyxin b for ophthalmic use, marketed by Harrow Eye, 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 upright at 8°C to 27°C (46°F to 80°F).
Key facts
- Active ingredient (INN)
- Dexamethasone, Neomycin and Polymyxin b
- Brand
- Maxitrol
- Strength
- 1 mg/3.5 mg/10000 units per mL
- Dosage form
- Ophthalmic suspension
- Route
- Ophthalmic
- Packs
- 5 mL
- Marketing authorisation holder
- Harrow Eye
- Manufacturer
- Harrow Eye
- Origin register
- US FDA, United States
- Storage
- Store upright at 8°C to 27°C (46°F to 80°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.32Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 November 1964
- Identifiers
- RxCUI 208591, 309680DailyMed set ID ecfb954f-5554-0ad2-e053-2995a90a7516NDC 82667-100Application NDA050023
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 |
|---|---|---|---|
| 5 mL in 1 bottle, plastic | 82667-100-05 | Harrow Eye | 1 November 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 6 June 1963 | 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 Dexamethasone, Neomycin and Polymyxin b 1 mg/3.5 mg/10000 units per mL ophthalmic suspension.
- Neomycin Polymyxin B Sulfates and Dexamethasone 1 mg/3.5 mg/10000 units per mL ophthalmic suspensionAvailable on requestBausch & LombUS FDA6 packs
- Neomycin and Polymyxin B Sulfates and Dexamethasone 1 mg/3.5 mg/10000 units per mL ophthalmic suspensionAvailable on requestSandozUS FDA2 packs
- Dexamethasone, Neomycin and Polymyxin b 1 mg/3.5 mg/10000 units per mL ophthalmic suspensionAvailable on request—US FDA1 pack
Other strengths and forms of Dexamethasone, Neomycin and Polymyxin b
Clinical summary
Dexamethasone, Neomycin and Polymyxin b is a fixed-dose combination of an aminoglycoside antibacterial, a corticosteroid and a polymyxin-class antibacterial indicated and where bacterial infection or a risk of bacterial infection exists. MedsAcross supplies Dexamethasone, Neomycin and Polymyxin b 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 Dexamethasone, Neomycin and Polymyxin bFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- neomycin sulfate, polymyxin b sulfate and dexamethasone prescribing information (Nordic Pharma) · U.S. National Library of Medicine, DailyMed
Need Maxitrol 1 mg/3.5 mg/10000 units per mL ophthalmic suspension 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.