Medicine
Prednisone 5 mg/5 mL oral solution
Prednisone 5 mg/5 mL oral solution is a generic prescription medicine for oral 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 20° to 25°C (68° to 77°F). NDC 0054-3722-50: Bottle of 120 mL NDC…
Key facts
- Active ingredient (INN)
- Prednisone
- Brand
- Sold under the generic name
- Strength
- 5 mg/5 mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 5 mL, 45 syringes, 120 mL and 2 more
- Manufacturers
- Atlantic Biologicals CorpsHikma Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). NDC 0054-3722-50: Bottle of 120 mL NDC 0054-3722-63: Bottle of 500 mL Store at 20° to 25°C (68° to 77°F). NDC 0054-3721-44: Bottle of 30 mL with calibrated oral syringe (graduations of 0.25 mL [1.25 mg] to 1 mL [5 mg] on the syringe) Store at 20° to 25°C (68° to 77°F). PROTECT FROM MOISTURE.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A07EA03 Prednisone
- HS code (indicative)
- 3004.32Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 8 November 1984
- Identifiers
- RxCUI 315187, 198144, 198145 +5DailyMed set ID 07be390e-ef1e-4bf9-a9da-4338b5f6cfa5, 3115aef0-fd50-4ec8-a064-3effb695f3f2NDC 17856-3722, 0054-3722Application ANDA088703
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 |
|---|---|---|---|
| 5 mL in 1 cup | 17856-3722-1 | Atlantic Biologicals Corps | 5 May 2016 |
| 45 syringe in 1 case / 5 mL in 1 syringe | 17856-3722-2 | Atlantic Biologicals Corps | 17 September 2026 |
| 45 syringe in 1 case / 5 mL in 1 syringe | 17856-3722-3 | Atlantic Biologicals Corps | 17 September 2026 |
| 120 mL in 1 bottle | 0054-3722-50 | Hikma Pharmaceuticals | 13 December 1996 |
| 500 mL in 1 bottle | 0054-3722-63 | Hikma Pharmaceuticals | 8 November 1984 |
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 21 February 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 Prednisone
Clinical summary
Prednisone is a corticosteroid indicated in the treatment of diseases or conditions, among other approved uses. It is available as tablets, delayed-release tablets and oral solution. MedsAcross supplies Prednisone 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 PrednisoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Prednisone delayed release prescribing information (Dr. Reddy's Laboratories) · U.S. National Library of Medicine, DailyMed
Need Prednisone 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.