Medicine
Prednisone 50 mg tablet
Prednisone 50 mg tablet is a generic prescription medicine for oral use, made by 18 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), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Prednisone
- Brand
- Sold under the generic name
- Strength
- 50 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 10 blister pack, 5 tablets and 103 more
- Manufacturers
- Aurobindo PharmaIndiaStrides PharmaIndiaProficient RxHikma PharmaceuticalsANI Pharmaceuticals18 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°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
- 14 March 2003
- Identifiers
- RxCUI 198145, 198146, 198148 +7DailyMed set ID b1ac4c92-e1fd-4015-b172-0932790ae019, 5393d51e-816b-4761-8e8a-7eadcf74245f, 3115aef0-fd50-4ec8-a064-3effb695f3f2 +26NDC 59651-489, 60687-854, 0054-0019 +26Application ANDA215672, ANDA208412, ANDA080352 +2
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
A sample of 40 packs from 18 labelers. The register lists 106 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 59651-489-01 | Aurobindo PharmaIndia | 28 March 2022 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 59651-489-78 | Aurobindo PharmaIndia | 28 March 2022 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 64380-949-01 | Strides PharmaIndia | 24 May 2022 |
| 100 tablet in 1 bottle | 64380-949-06 | Strides PharmaIndia | 24 May 2022 |
| 100 tablet in 1 bottle | 70954-061-10 | ANI Pharmaceuticals | 15 November 2019 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 0054-0019-20 | Hikma Pharmaceuticals | 14 March 2003 |
| 100 tablet in 1 bottle, plastic | 0054-0019-25 | Hikma Pharmaceuticals | 14 March 2003 |
| 5 tablet in 1 bottle, plastic | 63187-243-05 | Proficient Rx | 1 September 2014 |
| 7 tablet in 1 bottle, plastic | 63187-243-07 | Proficient Rx | 27 May 2022 |
| 8 tablet in 1 bottle, plastic | 63187-243-08 | Proficient Rx | 1 September 2014 |
| 10 tablet in 1 bottle, plastic | 63187-243-10 | Proficient Rx | 1 September 2014 |
| 15 tablet in 1 bottle, plastic | 63187-243-15 | Proficient Rx | 1 September 2014 |
| 20 tablet in 1 bottle, plastic | 63187-243-20 | Proficient Rx | 1 September 2014 |
| 21 tablet in 1 bottle, plastic | 63187-243-21 | Proficient Rx | 1 September 2014 |
| 30 tablet in 1 bottle, plastic | 63187-243-30 | Proficient Rx | 1 September 2014 |
| 40 tablet in 1 bottle, plastic | 63187-243-40 | Proficient Rx | 1 September 2014 |
| 5 tablet in 1 bottle | 71205-665-05 | Proficient Rx | 26 May 2022 |
| 10 tablet in 1 bottle | 71205-665-10 | Proficient Rx | 26 May 2022 |
| 20 tablet in 1 bottle | 71205-665-20 | Proficient Rx | 26 May 2022 |
| 21 tablet in 1 bottle | 71205-665-21 | Proficient Rx | 26 May 2022 |
| 24 tablet in 1 bottle | 71205-665-24 | Proficient Rx | 26 May 2022 |
| 30 tablet in 1 bottle | 71205-665-30 | Proficient Rx | 26 May 2022 |
| 60 tablet in 1 bottle | 71205-665-60 | Proficient Rx | 26 May 2022 |
| 90 tablet in 1 bottle | 71205-665-90 | Proficient Rx | 26 May 2022 |
| 5 tablet in 1 bottle | 71205-755-05 | Proficient Rx | 31 January 2023 |
| 6 tablet in 1 bottle | 71205-755-06 | Proficient Rx | 31 January 2023 |
| 7 tablet in 1 bottle | 71205-755-07 | Proficient Rx | 31 January 2023 |
| 10 tablet in 1 bottle | 71205-755-10 | Proficient Rx | 31 January 2023 |
| 12 tablet in 1 bottle | 71205-755-12 | Proficient Rx | 31 January 2023 |
| 14 tablet in 1 bottle | 71205-755-14 | Proficient Rx | 31 January 2023 |
| 15 tablet in 1 bottle | 71205-755-15 | Proficient Rx | 31 January 2023 |
| 18 tablet in 1 bottle | 71205-755-18 | Proficient Rx | 31 January 2023 |
| 20 tablet in 1 bottle | 71205-755-20 | Proficient Rx | 31 January 2023 |
| 21 tablet in 1 bottle | 71205-755-21 | Proficient Rx | 31 January 2023 |
| 24 tablet in 1 bottle | 71205-755-24 | Proficient Rx | 31 January 2023 |
| 28 tablet in 1 bottle | 71205-755-28 | Proficient Rx | 31 January 2023 |
| 30 tablet in 1 bottle | 71205-755-30 | Proficient Rx | 31 January 2023 |
| 60 tablet in 1 bottle | 71205-755-60 | Proficient Rx | 31 January 2023 |
| 90 tablet in 1 bottle | 71205-755-90 | Proficient Rx | 31 January 2023 |
| 5 tablet in 1 bottle | 82804-312-05 | Proficient Rx | 25 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 50 mg 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.