Medicine
Fenofibrate 54 mg tablet
Fenofibrate 54 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° to 25°C (68° to 77°F). Protect from moisture.
Key facts
- Active ingredient (INN)
- Fenofibrate
- Brand
- Sold under the generic name
- Strength
- 54 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 500 tablets, 90 tablets and 47 more
- Manufacturers
- Alembic PharmaceuticalsIndiaLaurus LabsIndiaMacleods PharmaceuticalsIndiaAjanta PharmaIndiaLifestar PharmaIndiaAurobindo PharmaIndiaDr. Reddy's LaboratoriesIndiaLupinIndiaA-S Medication SolutionsAmneal Pharmaceuticals of New York22 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° 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
- 13 May 2005
- Identifiers
- RxCUI 349287, 351133DailyMed set ID 5e7b79ab-9df0-4bbf-b7a4-a44aec203555, fa08cf6a-d306-4979-9b23-ac7febf4fd12, a504c42a-b629-4a21-a716-084962266b48 +26NDC 42858-454, 0115-5511, 33342-347 +26Application ANDA076433, ANDA076509, ANDA210379 +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 22 labelers. The register lists 50 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 | 46708-350-30 | Alembic PharmaceuticalsIndia | 23 January 2020 |
| 500 tablet, film coated in 1 bottle | 46708-350-71 | Alembic PharmaceuticalsIndia | 23 January 2020 |
| 90 tablet, film coated in 1 bottle | 46708-350-90 | Alembic PharmaceuticalsIndia | 23 January 2020 |
| 90 tablet, film coated in 1 bottle | 46708-554-90 | Alembic PharmaceuticalsIndia | 1 August 2019 |
| 30 tablet, film coated in 1 bottle | 62332-350-30 | Alembic PharmaceuticalsIndia | 23 January 2020 |
| 500 tablet, film coated in 1 bottle | 62332-350-71 | Alembic PharmaceuticalsIndia | 23 January 2020 |
| 90 tablet, film coated in 1 bottle | 62332-350-90 | Alembic PharmaceuticalsIndia | 23 January 2020 |
| 90 tablet, film coated in 1 bottle | 62332-538-90 | Alembic PharmaceuticalsIndia | 12 February 2019 |
| 90 tablet, film coated in 1 bottle | 62332-554-90 | Alembic PharmaceuticalsIndia | 1 August 2019 |
| 90 tablet in 1 bottle | 27241-116-03 | Ajanta PharmaIndia | 20 July 2018 |
| 500 tablet in 1 bottle | 27241-116-05 | Ajanta PharmaIndia | 20 July 2018 |
| 90 tablet, film coated in 1 bottle | 59651-575-90 | Aurobindo PharmaIndia | 27 September 2022 |
| 90 tablet, film coated in 1 bottle | 43598-909-90 | Dr. Reddy's LaboratoriesIndia | 31 January 2020 |
| 500 tablet, film coated in 1 bottle | 42385-935-05 | Laurus LabsIndia | 13 January 2020 |
| 1000 tablet, film coated in 1 bottle | 42385-935-11 | Laurus LabsIndia | 13 January 2020 |
| 30 tablet, film coated in 1 bottle | 42385-935-30 | Laurus LabsIndia | 13 January 2020 |
| 90 tablet, film coated in 1 bottle | 42385-935-90 | Laurus LabsIndia | 13 January 2020 |
| 500 tablet in 1 bottle | 70756-214-51 | Lifestar PharmaIndia | 10 September 2020 |
| 90 tablet in 1 bottle | 70756-214-90 | Lifestar PharmaIndia | 10 September 2020 |
| 90 tablet in 1 bottle | 68180-231-09 | LupinIndia | 1 July 2020 |
| 90 tablet in 1 container | 33342-347-10 | Macleods PharmaceuticalsIndia | 21 January 2026 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 33342-347-12 | Macleods PharmaceuticalsIndia | 21 January 2026 |
| 9 blister pack in 1 carton / 14 tablet in 1 blister pack | 33342-347-47 | Macleods PharmaceuticalsIndia | 21 January 2026 |
| 90 tablet in 1 bottle | 60219-5511-9 | Amneal Pharmaceuticals | 22 June 2022 |
| 90 tablet in 1 bottle | 69238-1262-9 | Amneal Pharmaceuticals NY | 23 March 2018 |
| 100 tablet in 1 bottle | 0115-5511-01 | Amneal Pharmaceuticals of New York | 1 February 2010 |
| 500 tablet in 1 bottle | 0115-5511-02 | Amneal Pharmaceuticals of New York | 1 February 2010 |
| 1000 tablet in 1 bottle | 0115-5511-03 | Amneal Pharmaceuticals of New York | 1 February 2010 |
| 90 tablet in 1 bottle | 0115-5511-10 | Amneal Pharmaceuticals of New York | 1 February 2010 |
| 63784 tablet, film coated in 1 box | 35561-343-00 | Bostal | 30 June 2019 |
| 90 tablet, film coated in 1 bottle | 35561-343-11 | Bostal | 30 June 2019 |
| 500 tablet, film coated in 1 bottle | 35561-343-13 | Bostal | 30 June 2019 |
| 90 tablet, film coated in 1 bottle | 62135-837-90 | Chartwell RX | 5 July 2024 |
| 90 tablet, film coated in 1 bottle | 69315-289-09 | Leading Pharma | 20 August 2022 |
| 90 tablet, film coated in 1 bottle | 42858-454-45 | Rhodes Pharmaceuticals | 1 June 2017 |
| 90 tablet in 1 bottle | 50090-5244-0 | A-S Medication Solutions | 12 October 2020 |
| 30 tablet in 1 bottle | 50090-5244-1 | A-S Medication Solutions | 12 October 2020 |
| 90 tablet in 1 bottle | 50090-6227-0 | A-S Medication Solutions | 14 November 2022 |
| 30 tablet in 1 bottle | 50090-6227-1 | A-S Medication Solutions | 14 November 2022 |
| 90 tablet, film coated in 1 bottle | 50090-7572-0 | A-S Medication Solutions | 5 June 2025 |
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 54 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.