Medicine
Prednisolone 5 mg/5 mL oral solution
Prednisolone 5 mg/5 mL oral solution is a generic prescription medicine for oral use, made by 4 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
May be refrigerated. Store at 20° to 25°C (68° to 77°F), excursions permitted…
Key facts
- Active ingredient (INN)
- Prednisolone
- Brand
- Sold under the generic name
- Strength
- 5 mg/5 mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 2 trays, 120 mL, 5 mL and 2 more
- Manufacturers
- Chartwell RXChartwell Governmental & Specialty RXPAI PharmaSeton Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- May be refrigerated. Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A07EA01 Prednisolone
- HS code (indicative)
- 3004.32Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 25 May 2004
- Identifiers
- RxCUI 312614DailyMed set ID 2d8c861d-3756-4b75-aaa9-1b82cf11eb94, 833ba492-8823-43b4-9a91-8b28d94a740b, d1f937e7-fed5-4079-bd52-5d930b34ae9f +1NDC 62135-330, 13925-166, 0121-1100 +1Application ANDA075988, NDA019157
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 |
|---|---|---|---|
| 2 tray in 1 box / 10 cup in 1 tray / 5 mL in 1 cup | 68999-330-24 | Chartwell Governmental & Specialty RX | 26 November 2025 |
| 2 tray in 1 box / 10 cup in 1 tray / 5 mL in 1 cup | 62135-330-24 | Chartwell RX | 14 October 2024 |
| 120 mL in 1 bottle | 62135-330-41 | Chartwell RX | 8 May 2021 |
| 5 mL in 1 bottle | 0121-1100-04 | PAI Pharma | 26 June 2026 |
| 120 mL in 1 bottle | 13925-166-04 | Seton Pharmaceuticals | 18 October 2013 |
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 22 May 1955 | 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 Prednisolone
Clinical summary
Prednisolone is a corticosteroid indicated for the treatment of mild to moderate noninfectious allergic and inflammatory disorders of the lid, conjunctiva, cornea, and sclera (including chemical and thermal burns). MedsAcross supplies Prednisolone 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 PrednisoloneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- PRED MILD prescribing information (Allergan) · U.S. National Library of Medicine, DailyMed
Need Prednisolone 5 mg/5 mL oral 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.