Medicine
Fenofibrate 43 mg capsule
Fenofibrate 43 mg capsule is a generic prescription medicine for oral use, made by 3 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), excursions permitted to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Fenofibrate
- Brand
- Sold under the generic name
- Strength
- 43 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules, 30 capsules and 2 more
- Manufacturers
- Dr. Reddy's LaboratoriesIndiaLupinIndiaApotex
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) in a tightly closed container.
- 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
- 22 February 2013
- Identifiers
- RxCUI 483425, 483427DailyMed set ID 68024459-987a-9cf4-f539-4959093bc9f0, 16ea8ce4-8c1c-4111-509e-86aa688d89a0, 37b25526-0bd0-4459-a4be-f3a6893506f9NDC 60505-3120, 55111-349, 68180-130Application ANDA202252, ANDA090859, NDA021695
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 |
|---|---|---|---|
| 100 capsule in 1 bottle | 55111-349-01 | Dr. Reddy's LaboratoriesIndia | 7 April 2014 |
| 30 capsule in 1 bottle | 55111-349-30 | Dr. Reddy's LaboratoriesIndia | 7 April 2014 |
| 30 capsule in 1 bottle | 68180-130-06 | LupinIndia | 22 February 2013 |
| 100 capsule in 1 bottle | 60505-3120-1 | Apotex | 26 July 2013 |
| 30 capsule in 1 bottle | 60505-3120-3 | Apotex | 26 July 2013 |
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
Alternatives
Other makers and brands of Fenofibrate 43 mg capsule.
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 43 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.