Medicine
Gemfibrozil 600 mg tablet
Gemfibrozil 600 mg tablet is a generic prescription medicine for oral use, made by 25 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). Protect from light and humidity.
Key facts
- Active ingredient (INN)
- Gemfibrozil
- Brand
- Sold under the generic name
- Strength
- 600 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 30 tablets and 118 more
- Manufacturers
- Zydus LifesciencesIndiaViona PharmaceuticalsIndiaCadila PharmaceuticalsIndiaCiplaIndiaAurobindo PharmaIndiaCamber PharmaceuticalsIndiaExelan PharmaceuticalsChartwell RXRising Pharma HoldingsXLCare Pharmaceuticals25 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20º to 25ºC (68º to 77ºF). Protect from light and humidity.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C10AB04 Gemfibrozil
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 27 September 1993
- Identifiers
- RxCUI 310459DailyMed set ID b5e33ee2-f766-41d6-8a4b-7b4f0e961bf4, 58c1f50b-9f84-42fe-b7dd-6eece286e28b, 4e9e08da-9700-4934-a2b1-4f64c70ea8a2 +37NDC 72603-206, 72865-186, 60687-224 +37Application ANDA202726, ANDA214603, ANDA077836 +5
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 25 labelers. The register lists 121 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 68382-553-01 | Zydus LifesciencesIndia | 15 January 2019 |
| 500 tablet in 1 bottle | 68382-553-05 | Zydus LifesciencesIndia | 15 January 2019 |
| 30 tablet in 1 bottle | 68382-553-06 | Zydus LifesciencesIndia | 15 January 2019 |
| 1000 tablet in 1 bottle | 68382-553-10 | Zydus LifesciencesIndia | 15 January 2019 |
| 60 tablet in 1 bottle | 68382-553-14 | Zydus LifesciencesIndia | 15 January 2019 |
| 90 tablet in 1 bottle | 68382-553-16 | Zydus LifesciencesIndia | 15 January 2019 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 68382-553-30 | Zydus LifesciencesIndia | 15 January 2019 |
| 1000 tablet in 1 bottle | 70771-1431-0 | Zydus LifesciencesIndia | 21 February 2020 |
| 100 tablet in 1 bottle | 70771-1431-1 | Zydus LifesciencesIndia | 21 February 2020 |
| 30 tablet in 1 bottle | 70771-1431-3 | Zydus LifesciencesIndia | 21 February 2020 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 70771-1431-4 | Zydus LifesciencesIndia | 21 February 2020 |
| 500 tablet in 1 bottle | 70771-1431-5 | Zydus LifesciencesIndia | 21 February 2020 |
| 60 tablet in 1 bottle | 70771-1431-6 | Zydus LifesciencesIndia | 21 February 2020 |
| 90 tablet in 1 bottle | 70771-1431-9 | Zydus LifesciencesIndia | 21 February 2020 |
| 500 tablet, film coated in 1 bottle | 65862-624-05 | Aurobindo PharmaIndia | 16 September 2015 |
| 60 tablet, film coated in 1 bottle | 65862-624-60 | Aurobindo PharmaIndia | 16 September 2015 |
| 60 tablet in 1 bottle | 71209-008-03 | Cadila PharmaceuticalsIndia | 17 October 2018 |
| 180 tablet in 1 bottle | 71209-008-08 | Cadila PharmaceuticalsIndia | 17 October 2018 |
| 500 tablet in 1 bottle | 71209-008-10 | Cadila PharmaceuticalsIndia | 17 October 2018 |
| 500 tablet in 1 bottle | 31722-128-05 | Camber PharmaceuticalsIndia | 20 January 2021 |
| 60 tablet in 1 bottle | 31722-128-60 | Camber PharmaceuticalsIndia | 20 January 2021 |
| 60 tablet in 1 bottle | 69097-821-03 | CiplaIndia | 13 October 2016 |
| 100 tablet in 1 bottle | 69097-821-07 | CiplaIndia | 13 October 2016 |
| 500 tablet in 1 bottle | 69097-821-12 | CiplaIndia | 13 October 2016 |
| 100 tablet in 1 bottle | 72578-066-01 | Viona PharmaceuticalsIndia | 21 February 2020 |
| 500 tablet in 1 bottle | 72578-066-05 | Viona PharmaceuticalsIndia | 21 February 2020 |
| 30 tablet in 1 bottle | 72578-066-06 | Viona PharmaceuticalsIndia | 21 February 2020 |
| 1000 tablet in 1 bottle | 72578-066-10 | Viona PharmaceuticalsIndia | 21 February 2020 |
| 60 tablet in 1 bottle | 72578-066-14 | Viona PharmaceuticalsIndia | 21 February 2020 |
| 90 tablet in 1 bottle | 72578-066-16 | Viona PharmaceuticalsIndia | 21 February 2020 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 72578-066-77 | Viona PharmaceuticalsIndia | 21 February 2020 |
| 300 tablet, film coated in 1 bottle | 62135-160-31 | Chartwell RX | 25 August 2023 |
| 60 tablet, film coated in 1 bottle | 62135-160-60 | Chartwell RX | 25 August 2023 |
| 500 tablet, film coated in 1 bottle | 76282-225-05 | Exelan Pharmaceuticals | 20 October 2006 |
| 180 tablet, film coated in 1 bottle | 76282-225-18 | Exelan Pharmaceuticals | 20 October 2006 |
| 60 tablet, film coated in 1 bottle | 76282-225-60 | Exelan Pharmaceuticals | 20 October 2006 |
| 60 tablet, film coated in 1 bottle | 16571-784-06 | Rising Pharma Holdings | 16 September 2015 |
| 500 tablet, film coated in 1 bottle | 16571-784-50 | Rising Pharma Holdings | 16 September 2015 |
| 500 tablet in 1 bottle | 72865-186-05 | XLCare Pharmaceuticals | 20 January 2021 |
| 180 tablet in 1 bottle | 72865-186-18 | XLCare Pharmaceuticals | 20 January 2021 |
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 21 December 1981 | 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
Clinical summary
Gemfibrozil is a peroxisome proliferator receptor alpha agonist indicated as adjunctive therapy to diet for treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia), among other approved uses. MedsAcross supplies Gemfibrozil 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 GemfibrozilFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Gemfibrozil prescribing information (Northstar RxLLC) · U.S. National Library of Medicine, DailyMed
Need Gemfibrozil 600 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.