Medicine
Prednisone 5 mg tablet
Prednisone 5 mg tablet is a generic prescription medicine for oral use, made by 31 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).
Key facts
- Active ingredient (INN)
- Prednisone
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 10 blister pack, 1000 tablets and 239 more
- Manufacturers
- Aurobindo PharmaIndiaStrides PharmaIndiaA-S Medication SolutionsHikma PharmaceuticalsActavis PharmaANI PharmaceuticalsPar HealthAmneal Pharmaceuticals NYGranulation TechnologyChartwell RX31 labelers on the register
- Origin register
- US FDA, United States
- Storage
- 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
- A07EA03 Prednisone
- HS code (indicative)
- 3004.32Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 21 April 1972
- Identifiers
- RxCUI 312617, 198145, 312615 +7DailyMed set ID 91167f27-6f36-4b89-a530-be26209e4301, af863b9e-964b-3b1e-e053-2995a90ab93a, b3dbf833-b929-8c85-e053-2995a90a5896 +37NDC 72162-2149, 80425-0069, 80425-0106 +37Application ANDA080292, ANDA040362, ANDA213385 +10
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 31 labelers. The register lists 242 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 59651-486-01 | Aurobindo PharmaIndia | 28 March 2022 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 59651-486-78 | Aurobindo PharmaIndia | 28 March 2022 |
| 1000 tablet in 1 bottle | 59651-486-99 | Aurobindo PharmaIndia | 28 March 2022 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 64380-783-01 | Strides PharmaIndia | 1 September 2021 |
| 100 tablet in 1 bottle, plastic | 64380-783-06 | Strides PharmaIndia | 1 September 2021 |
| 1000 tablet in 1 bottle, plastic | 64380-783-08 | Strides PharmaIndia | 1 September 2021 |
| 100 tablet in 1 bottle, plastic | 0054-4728-25 | Hikma Pharmaceuticals | 21 April 1972 |
| 1000 tablet in 1 bottle, plastic | 0054-4728-31 | Hikma Pharmaceuticals | 21 April 1972 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 0054-8724-25 | Hikma Pharmaceuticals | 21 April 1972 |
| 100 tablet in 1 bottle | 0054-9828-25 | Hikma Pharmaceuticals | 23 March 2020 |
| 1000 tablet in 1 bottle | 0054-9828-31 | Hikma Pharmaceuticals | 23 March 2020 |
| 100 tablet in 1 bottle | 0591-5052-01 | Actavis Pharma | 1 January 1990 |
| 1000 tablet in 1 bottle | 0591-5052-10 | Actavis Pharma | 1 January 1990 |
| 1 blister pack in 1 carton / 21 tablet in 1 blister pack | 0591-5052-21 | Actavis Pharma | 25 May 2016 |
| 1 blister pack in 1 carton / 48 tablet in 1 blister pack | 0591-5052-43 | Actavis Pharma | 25 May 2016 |
| 100 tablet in 1 bottle, plastic | 60219-1706-1 | Amneal Pharmaceuticals NY | 4 August 2021 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 60219-1706-3 | Amneal Pharmaceuticals NY | 4 August 2021 |
| 1000 tablet in 1 bottle, plastic | 60219-1706-7 | Amneal Pharmaceuticals NY | 4 August 2021 |
| 100 tablet in 1 bottle | 70954-058-10 | ANI Pharmaceuticals | 15 November 2019 |
| 1000 tablet in 1 bottle | 70954-058-20 | ANI Pharmaceuticals | 15 November 2019 |
| 1 blister pack in 1 box / 21 tablet in 1 blister pack | 70954-058-30 | ANI Pharmaceuticals | 28 May 2020 |
| 1 blister pack in 1 box / 48 tablet in 1 blister pack | 70954-058-40 | ANI Pharmaceuticals | 28 May 2020 |
| 180 tablet in 1 bottle | 62135-471-18 | Chartwell RX | 23 January 2023 |
| 90 tablet in 1 bottle | 62135-471-90 | Chartwell RX | 23 January 2023 |
| 100 tablet in 1 bottle | 63561-0120-1 | Granulation Technology | 22 May 2025 |
| 1000 tablet in 1 bottle | 63561-0120-2 | Granulation Technology | 22 May 2025 |
| 500 tablet in 1 bottle | 63561-0120-5 | Granulation Technology | 22 May 2025 |
| 100 tablet in 1 bottle, plastic | 0378-0640-01 | Mylan Pharmaceuticals | 7 March 2019 |
| 1000 tablet in 1 bottle, plastic | 0378-0640-10 | Mylan Pharmaceuticals | 7 March 2019 |
| 21 tablet in 1 box, unit-dose | 0603-5337-15 | Par Health | 12 July 2002 |
| 100 tablet in 1 bottle, plastic | 0603-5337-21 | Par Health | 12 July 2002 |
| 48 tablet in 1 box, unit-dose | 0603-5337-31 | Par Health | 12 July 2002 |
| 1000 tablet in 1 bottle, plastic | 0603-5337-32 | Par Health | 12 July 2002 |
| 21 tablet in 1 box, unit-dose | 50090-0439-0 | A-S Medication Solutions | 29 June 2016 |
| 21 tablet in 1 bottle, plastic | 50090-3354-0 | A-S Medication Solutions | 28 November 2014 |
| 50 tablet in 1 bottle | 50090-3354-1 | A-S Medication Solutions | 31 January 2018 |
| 100 tablet in 1 bottle | 50090-3354-3 | A-S Medication Solutions | 16 February 2018 |
| 30 tablet in 1 bottle, plastic | 50090-3354-4 | A-S Medication Solutions | 28 November 2014 |
| 60 tablet in 1 bottle | 50090-3354-7 | A-S Medication Solutions | 30 January 2018 |
| 40 tablet in 1 bottle | 50090-3361-4 | A-S Medication Solutions | 2 February 2018 |
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 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.