Medicine
Prednisone 5 mg delayed-release tablet
Prednisone 5 mg delayed-release tablet 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
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Prednisone
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Delayed-release tablet
- Route
- Oral
- Packs
- 1 bottle
- Manufacturer
- Dr. Reddy's LaboratoriesIndia
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
- 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
- 12 August 2026
- Identifiers
- RxCUI 1303135DailyMed set ID 474974ac-9811-c9f5-4050-58e535351d00NDC 43598-888Application ANDA218035
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle in 1 carton / 100 tablet, delayed release in 1 bottle | 43598-888-01 | Dr. Reddy's LaboratoriesIndia | 12 August 2026 |
| 1 bottle in 1 carton / 30 tablet, delayed release in 1 bottle | 43598-888-30 | Dr. Reddy's LaboratoriesIndia | 12 August 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 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 delayed-release tablet 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.