Medicine
Choline fenofibrate 45 mg delayed-release capsule
Choline fenofibrate 45 mg delayed-release capsule is a generic prescription medicine for oral use, made by 2 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). Protect…
Key facts
- Active ingredient (INN)
- Choline fenofibrate
- Brand
- Sold under the generic name
- Strength
- 45 mg
- Dosage form
- Delayed-release capsule
- Route
- Oral
- Packs
- 90 capsules, 10 blister pack
- Manufacturer
- Macleods PharmaceuticalsIndia2 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15 to 30°C (59 to 86°F). Protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C10AB11 Choline fenofibrate
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 4 December 2013
- Identifiers
- RxCUI 828373, 828379DailyMed set ID b9a3f97c-9e31-4a5f-822f-c9d45e394493, af225492-73b0-49bb-b32f-5399c3c3ec6dNDC 68180-128, 33342-294Application ANDA200750, ANDA207796
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 90 capsule, delayed release in 1 bottle | 33342-294-10 | Macleods PharmaceuticalsIndia | 26 February 2024 |
| 10 blister pack in 1 carton / 10 capsule, delayed release in 1 blister pack | 33342-294-12 | Macleods PharmaceuticalsIndia | 26 February 2024 |
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 15 December 2008 | 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 Choline fenofibrate
Clinical summary
Choline fenofibrate is a peroxisome proliferator receptor alpha agonist indicated as adjunctive therapy to diet, among other approved uses. It is available as delayed-release capsules for oral use. MedsAcross supplies Choline 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 Choline 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
- Fenofibric acid prescribing information (Macleods Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Choline fenofibrate 45 mg delayed-release 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.