Medicine
Hydrocortisone, Neomycin and Polymyxin b 10 mg/3.5 mg/10000 IU per mL ear drops
Hydrocortisone, Neomycin and Polymyxin b 10 mg/3.5 mg/10000 IU per mL ear drops is a generic prescription medicine for otic use, made by 2 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).
Key facts
- Active ingredient (INN)
- Hydrocortisone, Neomycin and Polymyxin b
- Brand
- Sold under the generic name
- Strength
- 10 mg/3.5 mg/10000 IU per mL
- Dosage form
- Ear drops
- Route
- Otic
- Packs
- 1 bottle
- Manufacturers
- Orbicular Pharmaceutical TechnologiesIndiaHikma Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 15° to 25°C (59° to 77°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
- 8 October 2026
- Identifiers
- RxCUI 204423DailyMed set ID 5eae31aa-ec63-4b93-9859-8d718a8ac8ef, 2846b507-f92d-45e0-9807-f68bdf4de56cNDC 81607-014, 0054-0975Application ANDA220938
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 / 10 mL in 1 bottle, dropper | 81607-014-10 | Orbicular Pharmaceutical TechnologiesIndia | 8 October 2026 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 0054-0975-80 | Hikma Pharmaceuticals | 8 October 2026 |
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 16 April 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
Other strengths and forms of Hydrocortisone, Neomycin and Polymyxin b
Clinical summary
Hydrocortisone, Neomycin and Polymyxin b is a fixed-dose combination of an aminoglycoside antibacterial, a corticosteroid and a polymyxin-class antibacterial. It is available as otic suspension, ear drops and otic solution for ophthalmic use. MedsAcross supplies Hydrocortisone, 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 Hydrocortisone, 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 and Polymyxin B Sulfates and Hydrocortisone Otic Suspension prescribing information (Rising Pharma Holdings) · U.S. National Library of Medicine, DailyMed
Need Hydrocortisone, Neomycin and Polymyxin b 10 mg/3.5 mg/10000 IU per mL ear 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.