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Medicine

Prednisolone 15 mg/5 mL syrup

Prednisolone · Oral
Available on requestPrescription onlyUS FDAGeneric name

Prednisolone 15 mg/5 mL syrup is a generic prescription medicine for oral use, 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

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Do Not Refrigerate. Store at 20° to 25°C (68° to 77°F).

Key facts

Active ingredient (INN)
Prednisolone
Brand
Sold under the generic name
Strength
15 mg/5 mL
Dosage form
Syrup
Route
Oral
Packs
240 mL, 480 mL
Manufacturer
Lannett
Origin register
US FDA, United States
Storage
Do Not Refrigerate. Store at 20° to 25°C (68° to 77°F).
Cold chain
Not required on record
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
21 September 2007
Identifiers
RxCUI 283077DailyMed set ID 86652e2d-664a-4388-a611-c2a9aa4a4bc8NDC 0527-5406Application ANDA040775

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

PackCodeLabelerMarketed since
240 mL in 1 bottle0527-5406-68Lannett21 September 2007
480 mL in 1 bottle0527-5406-70Lannett21 September 2007

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 22 May 1955Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS 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 Prednisolone

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Prednisolone 15 mg/5 mL syrup 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.