Medicine
Prednisolone and Sulfacetamide 2.3 mg/100 mg per mL eye drops
Prednisolone and Sulfacetamide 2.3 mg/100 mg per mL eye drops is a generic prescription medicine for ophthalmic 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
KEEP FROM FREEZING. Store between 15°–25°C (59°–77°F). PROTECT FROM LIGHT.
Key facts
- Active ingredient (INN)
- Prednisolone and Sulfacetamide
- Brand
- Sold under the generic name
- Strength
- 2.3 mg/100 mg per mL
- Dosage form
- Eye drops
- Route
- Ophthalmic
- Packs
- 1 bottle, 5 mL
- Manufacturers
- Bausch & Lomb IncoporatedNuCare Pharmaceuticals,Inc
- Origin register
- US FDA, United States
- Storage
- KEEP FROM FREEZING. Store between 15°–25°C (59°–77°F). PROTECT FROM LIGHT.
- 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
- 29 December 1995
- Identifiers
- RxCUI 1012021DailyMed set ID 835def0b-ed5a-61a0-e053-2a91aa0ae7ae, 9ec403eb-b5df-4e41-9e17-9d9d8ecac3f3NDC 68071-1650, 24208-317Application ANDA074449
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 / 5 mL in 1 bottle, dropper | 24208-317-05 | Bausch & Lomb Incoporated | 29 December 1995 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 24208-317-10 | Bausch & Lomb Incoporated | 29 December 1995 |
| 5 mL in 1 box | 68071-1650-5 | NuCare Pharmaceuticals,Inc | 5 March 2019 |
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 18 September 1961 | 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
Clinical summary
Prednisolone and Sulfacetamide is a fixed-dose combination of a corticosteroid and a sulfonamide antibacterial. It is available as eye drops for ophthalmic use. MedsAcross supplies Prednisolone and Sulfacetamide 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 Prednisolone and SulfacetamideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Sulfacetamide Sodium and Prednisolone Sodium Phosphate prescribing information (Bausch & Lomb Incoporated) · U.S. National Library of Medicine, DailyMed
Need Prednisolone and Sulfacetamide 2.3 mg/100 mg per 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.