Medicine
Fenofibrate 200 mg capsule
Fenofibrate 200 mg capsule is a generic prescription medicine for oral use, made by 11 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 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F).Keep…
Key facts
- Active ingredient (INN)
- Fenofibrate
- Brand
- Sold under the generic name
- Strength
- 200 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 30 capsules, 100 capsules, 500 capsules and 21 more
- Manufacturers
- Alembic PharmaceuticalsIndiaCiplaIndiaTorrent PharmaceuticalsIndiaAjanta PharmaIndiaAurobindo PharmaIndiaGlenmark PharmaceuticalsIndiaBostalANI PharmaceuticalsA-S Medication SolutionsAmerican Health Packaging
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F).Keep out of the reach of children. 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
- 30 March 2017
- Identifiers
- RxCUI 200311, 310288, 310289DailyMed set ID 954753e7-c8d4-487c-b2ad-f90dfb758a92, 2d0cfddc-ace3-4187-8d94-d760d23d20b6, 07d47c02-ab29-4ba9-aea0-96ffbd70c0ef +9NDC 46708-086, 62135-899, 69097-896 +9Application ANDA213842, ANDA211407, ANDA207378 +6
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 capsule in 1 bottle | 46708-086-30 | Alembic PharmaceuticalsIndia | 22 October 2020 |
| 100 capsule in 1 bottle | 46708-086-31 | Alembic PharmaceuticalsIndia | 22 October 2020 |
| 500 capsule in 1 bottle | 46708-086-71 | Alembic PharmaceuticalsIndia | 22 October 2020 |
| 30 capsule in 1 bottle | 62332-086-30 | Alembic PharmaceuticalsIndia | 22 October 2020 |
| 100 capsule in 1 bottle | 62332-086-31 | Alembic PharmaceuticalsIndia | 22 October 2020 |
| 500 capsule in 1 bottle | 62332-086-71 | Alembic PharmaceuticalsIndia | 22 October 2020 |
| 100 capsule in 1 bottle | 27241-120-04 | Ajanta PharmaIndia | 10 September 2018 |
| 500 capsule in 1 bottle | 27241-120-05 | Ajanta PharmaIndia | 1 August 2019 |
| 100 capsule in 1 bottle | 59651-203-01 | Aurobindo PharmaIndia | 20 September 2021 |
| 30 capsule in 1 bottle, plastic | 69097-896-02 | CiplaIndia | 30 March 2017 |
| 100 capsule in 1 bottle, plastic | 69097-896-07 | CiplaIndia | 30 March 2017 |
| 500 capsule in 1 bottle, plastic | 69097-896-12 | CiplaIndia | 30 March 2017 |
| 100 capsule in 1 bottle | 68462-582-01 | Glenmark PharmaceuticalsIndia | 7 April 2017 |
| 100 capsule in 1 bottle | 13668-438-01 | Torrent PharmaceuticalsIndia | 1 July 2018 |
| 500 capsule in 1 bottle | 13668-438-05 | Torrent PharmaceuticalsIndia | 1 July 2018 |
| 90 capsule in 1 bottle | 13668-438-90 | Torrent PharmaceuticalsIndia | 1 July 2018 |
| 100 capsule in 1 bottle | 43975-306-10 | ANI Pharmaceuticals | 1 May 2018 |
| 500 capsule in 1 bottle | 43975-306-50 | ANI Pharmaceuticals | 1 May 2018 |
| 90 capsule in 1 bottle | 35561-347-11 | Bostal | 17 November 2017 |
| 100 capsule in 1 bottle | 35561-347-12 | Bostal | 20 November 2020 |
| 500 capsule in 1 bottle | 35561-347-13 | Bostal | 20 November 2020 |
| 90 capsule in 1 bottle | 62135-899-90 | Chartwell RX | 12 September 2024 |
| 90 capsule in 1 bottle | 50090-7994-0 | A-S Medication Solutions | 9 June 2026 |
| 30 blister pack in 1 carton / 1 capsule in 1 blister pack | 60687-713-21 | American Health Packaging | 13 March 2023 |
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 200 mg capsule 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.