Medicine
Fenofibrate 48 mg tablet
Fenofibrate 48 mg tablet is a generic prescription medicine for oral use, made by 22 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°C to 25°C (68°F to 77°F). Protect from moisture.
Key facts
- Active ingredient (INN)
- Fenofibrate
- Brand
- Sold under the generic name
- Strength
- 48 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 500 tablets, 90 tablets and 51 more
- Manufacturers
- Alembic PharmaceuticalsIndiaAurobindo PharmaIndiaCamber PharmaceuticalsIndiaMacleods PharmaceuticalsIndiaLaurus LabsIndiaCiplaIndiaLupinIndiaBostalA-S Medication SolutionsBryant Ranch Prepack22 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F). Protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C10AB05 Fenofibrate
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 14 May 2013
- Identifiers
- RxCUI 477560, 477562DailyMed set ID 38f43148-4ca0-402a-ba39-8ee5011a7907, e949c068-bc7d-3038-e053-2a95a90aee00, f8f09ab1-74db-4123-b85a-6337dc2582a0 +24NDC 31722-595, 50268-338, 69097-459 +24Application ANDA204598, ANDA090856, ANDA208709 +8
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 22 labelers. The register lists 54 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 tablet, film coated in 1 bottle | 46708-360-30 | Alembic PharmaceuticalsIndia | 9 August 2019 |
| 500 tablet, film coated in 1 bottle | 46708-360-71 | Alembic PharmaceuticalsIndia | 9 August 2019 |
| 90 tablet, film coated in 1 bottle | 46708-360-90 | Alembic PharmaceuticalsIndia | 9 August 2019 |
| 30 tablet, film coated in 1 bottle | 62332-360-30 | Alembic PharmaceuticalsIndia | 9 August 2019 |
| 500 tablet, film coated in 1 bottle | 62332-360-71 | Alembic PharmaceuticalsIndia | 9 August 2019 |
| 90 tablet, film coated in 1 bottle | 62332-360-90 | Alembic PharmaceuticalsIndia | 9 August 2019 |
| 100 tablet, coated in 1 bottle | 65862-768-01 | Aurobindo PharmaIndia | 5 May 2016 |
| 500 tablet, coated in 1 bottle | 65862-768-05 | Aurobindo PharmaIndia | 5 May 2016 |
| 10 blister pack in 1 carton / 10 tablet, coated in 1 blister pack | 65862-768-78 | Aurobindo PharmaIndia | 5 May 2016 |
| 90 tablet, coated in 1 bottle | 65862-768-90 | Aurobindo PharmaIndia | 5 May 2016 |
| 1000 tablet, coated in 1 bottle | 65862-768-99 | Aurobindo PharmaIndia | 5 May 2016 |
| 30 tablet, film coated in 1 bottle | 31722-595-30 | Camber PharmaceuticalsIndia | 14 July 2016 |
| 100 tablet, film coated in 1 blister pack | 31722-595-31 | Camber PharmaceuticalsIndia | 14 July 2016 |
| 100 tablet, film coated in 1 blister pack | 31722-595-32 | Camber PharmaceuticalsIndia | 14 July 2016 |
| 90 tablet, film coated in 1 bottle | 31722-595-90 | Camber PharmaceuticalsIndia | 14 July 2016 |
| 30 tablet in 1 bottle | 69097-459-02 | CiplaIndia | 15 December 2016 |
| 90 tablet in 1 bottle | 69097-459-05 | CiplaIndia | 15 December 2016 |
| 1000 tablet in 1 bottle | 42385-950-11 | Laurus LabsIndia | 18 March 2020 |
| 30 tablet in 1 bottle | 42385-950-30 | Laurus LabsIndia | 18 March 2020 |
| 90 tablet in 1 bottle | 42385-950-90 | Laurus LabsIndia | 18 March 2020 |
| 90 tablet in 1 bottle | 68180-388-09 | LupinIndia | 1 August 2020 |
| 30 tablet in 1 bottle | 33342-339-07 | Macleods PharmaceuticalsIndia | 13 November 2024 |
| 90 tablet in 1 bottle | 33342-339-10 | Macleods PharmaceuticalsIndia | 13 November 2024 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 33342-339-12 | Macleods PharmaceuticalsIndia | 13 November 2024 |
| 500 tablet in 1 bottle | 33342-339-15 | Macleods PharmaceuticalsIndia | 13 November 2024 |
| 90 tablet in 1 bottle | 69238-1260-9 | Amneal Pharmaceuticals NY | 15 February 2018 |
| 500 tablet, film coated in 1 bottle | 35561-249-03 | Bostal | 7 August 2025 |
| 30 tablet, film coated in 1 bottle | 35561-249-10 | Bostal | 1 January 2021 |
| 90 tablet, film coated in 1 bottle | 35561-249-11 | Bostal | 15 August 2025 |
| 500 tablet, film coated in 1 bottle | 35561-249-13 | Bostal | 1 January 2021 |
| 90 tablet in 1 bottle | 69315-287-09 | Leading Pharma | 18 July 2022 |
| 100 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack | 51079-599-20 | Mylan Institutional | 10 June 2013 |
| 90 tablet, film coated in 1 bottle, plastic | 0378-3065-77 | Mylan Pharmaceuticals | 14 May 2013 |
| 90 tablet in 1 bottle | 43547-430-09 | Solco Healthcare | 20 February 2019 |
| 500 tablet in 1 bottle | 43547-430-50 | Solco Healthcare | 20 February 2019 |
| 90 tablet, film coated in 1 bottle | 50090-3056-0 | A-S Medication Solutions | 14 June 2017 |
| 90 tablet, coated in 1 bottle | 50090-3887-0 | A-S Medication Solutions | 30 November 2018 |
| 90 tablet in 1 bottle | 50090-5327-0 | A-S Medication Solutions | 30 October 2020 |
| 30 tablet in 1 bottle | 71335-0891-1 | Bryant Ranch Prepack | 8 April 2021 |
| 90 tablet in 1 bottle | 71335-0891-2 | Bryant Ranch Prepack | 2 July 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 31 December 1993 | 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 Fenofibrate
Clinical summary
Fenofibrate is a peroxisome proliferator receptor alpha agonist indicated as adjunctive therapy to diet. It is available as tablets and capsules for oral use. MedsAcross supplies Fenofibrate 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 FenofibrateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ANTARA prescribing information (Lupin) · U.S. National Library of Medicine, DailyMed
Need Fenofibrate 48 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.