Medicine
Fenofibric acid 135 mg delayed-release capsule
Fenofibric acid 135 mg delayed-release capsule is a generic prescription medicine for oral use, made by 4 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 20º to 25ºC (68º to 77ºF), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Fenofibric acid
- Brand
- Sold under the generic name
- Strength
- 135 mg
- Dosage form
- Delayed-release capsule
- Route
- Oral
- Packs
- 30 capsules, 90 capsules, 1000 capsules and 6 more
- Manufacturers
- Alembic PharmaceuticalsIndiaAurobindo PharmaIndiaAmneal Pharmaceuticals of New YorkLeading Pharma
- Origin register
- US FDA, United States
- Storage
- Store at 20º to 25ºC (68º to 77ºF), 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
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 May 2017
- Identifiers
- RxCUI 828373, 828379DailyMed set ID daa488be-f580-430c-a72c-80ac31bb3e40, c880d43a-fa8c-4f7a-a488-419bae7cc311, 9ad201de-fa62-4c49-bc61-ee09b9ba434c +2NDC 69315-282, 46708-245, 59651-217 +2Application ANDA211626, ANDA208705, ANDA212598 +1
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, delayed release in 1 bottle | 46708-245-30 | Alembic PharmaceuticalsIndia | 18 May 2017 |
| 90 capsule, delayed release in 1 bottle | 46708-245-90 | Alembic PharmaceuticalsIndia | 18 May 2017 |
| 1000 capsule, delayed release in 1 bottle | 46708-245-91 | Alembic PharmaceuticalsIndia | 18 May 2017 |
| 30 capsule, delayed release in 1 bottle | 62332-245-30 | Alembic PharmaceuticalsIndia | 15 May 2017 |
| 90 capsule, delayed release in 1 bottle | 62332-245-90 | Alembic PharmaceuticalsIndia | 15 May 2017 |
| 1000 capsule, delayed release in 1 bottle | 62332-245-91 | Alembic PharmaceuticalsIndia | 15 May 2017 |
| 90 capsule, delayed release in 1 bottle | 59651-217-90 | Aurobindo PharmaIndia | 25 July 2019 |
| 90 capsule, delayed release in 1 bottle | 0115-1325-10 | Amneal Pharmaceuticals of New York | 1 June 2024 |
| 90 capsule, delayed release in 1 bottle | 69315-282-09 | Leading Pharma | 18 July 2019 |
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 14 August 2009 | 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 Fenofibric acid
Clinical summary
Fenofibric acid 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 Fenofibric acid 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 Fenofibric acidFor 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 (Alembic Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Fenofibric acid 135 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.