Medicine
Prednisolone 15 mg/5 mL oral solution
Prednisolone 15 mg/5 mL oral solution is a generic prescription medicine for oral use, made by 13 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 unit dose cups refrigerated, 2° to 8°C (36° to…
Key facts
- Active ingredient (INN)
- Prednisolone
- Brand
- Sold under the generic name
- Strength
- 15 mg/5 mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 240 mL, 480 mL, 237 mL and 26 more
- Manufacturers
- Avet Pharmaceuticals LabsIndiaAtlantic BiologicalsPAI PharmaA-S Medication SolutionsChartwell RXRemedyrepackPreferred PharmaceuticalsTruPharmaAmneal Pharmaceuticals NYChartwell Governmental & Specialty RX
- Origin register
- US FDA, United States
- Storage
- May be refrigerated. Store unit dose cups refrigerated, 2° to 8°C (36° to 46°F). May be stored at controlled room temperature, 20° to 25°C (68° to 77°F) for up to 6 months or until manufacturer expiration date, whichever is earlier after removing from the refrigerator. Store bottles at 2° to 25°C (36° to 77°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 April 2005
- Identifiers
- RxCUI 283077, 249066, 702306 +1DailyMed set ID a0d74ae0-7b2d-4d36-9211-c76f5063b5a9, 7262fc84-3db2-4475-8ae4-6bec4477cb81, 96de9cad-2fb7-4947-87ae-4db57563a83a +14NDC 0121-4759, 68788-4046, 17856-0815 +15Application ANDA076913, ANDA203559, ANDA040571 +3
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 |
|---|---|---|---|
| 240 mL in 1 bottle | 23155-927-51 | Avet Pharmaceuticals LabsIndia | 1 March 2025 |
| 480 mL in 1 bottle | 23155-927-52 | Avet Pharmaceuticals LabsIndia | 1 March 2025 |
| 237 mL in 1 bottle | 0121-0759-08 | PAI Pharma | 25 April 2005 |
| 240 mL in 1 bottle | 0121-0885-08 | PAI Pharma | 12 September 2023 |
| 480 mL in 1 bottle | 0121-0885-16 | PAI Pharma | 12 September 2023 |
| 5 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 0121-4759-50 | PAI Pharma | 22 March 2024 |
| 237 mL in 1 bottle | 69238-2122-9 | Amneal Pharmaceuticals NY | 27 October 2022 |
| 2 tray in 1 box / 10 cup in 1 tray / 5 mL in 1 cup | 68999-250-24 | Chartwell Governmental & Specialty RX | 14 November 2025 |
| 2 tray in 1 box / 10 cup in 1 tray / 5 mL in 1 cup | 62135-250-24 | Chartwell RX | 31 May 2024 |
| 240 mL in 1 bottle | 62135-250-37 | Chartwell RX | 20 November 2022 |
| 480 mL in 1 bottle | 62135-250-47 | Chartwell RX | 20 November 2022 |
| 237 mL in 1 bottle, plastic | 42799-815-01 | Edenbridge Pharmaceuticals | 9 October 2023 |
| 240 mL in 1 bottle | 52817-860-08 | Trupharma | 4 August 2026 |
| 480 mL in 1 bottle | 52817-860-16 | Trupharma | 4 August 2026 |
| 237 mL in 1 bottle | 50090-1582-0 | A-S Medication Solutions | 29 December 2014 |
| 2 bottle, dispensing in 1 bottle / 120 mL in 1 bottle, dispensing | 50090-7115-0 | A-S Medication Solutions | 12 March 2024 |
| 4 bottle, dispensing in 1 bottle / 60 mL in 1 bottle, dispensing | 50090-7115-1 | A-S Medication Solutions | 12 March 2024 |
| 72 cup, unit-dose in 1 box, unit-dose / 5 mL in 1 cup, unit-dose | 17856-0815-1 | Atlantic Biologicals | 15 January 2025 |
| 72 cup, unit-dose in 1 box, unit-dose / 10 mL in 1 cup, unit-dose | 17856-0815-2 | Atlantic Biologicals | 15 January 2025 |
| 48 syringe in 1 box, unit-dose / 5 mL in 1 syringe | 17856-0815-3 | Atlantic Biologicals | 15 January 2025 |
| 45 syringe in 1 box, unit-dose / 5 mL in 1 syringe | 17856-0815-5 | Atlantic Biologicals | 4 September 2026 |
| 50 cup, unit-dose in 1 case / 5 mL in 1 cup, unit-dose | 17856-8815-1 | Atlantic Biologicals | 1 October 2025 |
| 237 mL in 1 bottle, plastic | 68788-4046-2 | Preferred Pharmaceuticals | 28 October 2025 |
| 237 mL in 1 bottle | 68788-7708-2 | Preferred Pharmaceuticals | 1 June 2020 |
| 240 mL in 1 bottle | 63187-215-64 | Proficient Rx | 1 September 2014 |
| 60 mL in 1 bottle, plastic | 67296-2134-6 | Redpharm Drug | 9 October 2023 |
| 2 cup in 1 box / 25 mL in 1 cup | 70518-4524-0 | Remedyrepack | 28 November 2025 |
| 5 cup in 1 box / 10 mL in 1 cup | 70518-4524-2 | Remedyrepack | 10 December 2025 |
| 10 cup in 1 box / 5 mL in 1 cup | 70518-4524-4 | Remedyrepack | 9 February 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 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 15 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.