Medicine
Colesevelam 625 mg tablet
Colesevelam 625 mg tablet is a generic prescription medicine for oral use, made by 13 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 between 15…
Key facts
- Active ingredient (INN)
- Colesevelam
- Brand
- Sold under the generic name
- Strength
- 625 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1000 tablets, 180 tablets, 10 blister pack and 30 more
- Manufacturers
- Zydus LifesciencesIndiaAscend LaboratoriesIndiaGlenmark PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaMacleods PharmaceuticalsIndiaA-S Medication SolutionsBionpharmaBryant Ranch PrepackAmerican Health PackagingAmneal Pharmaceuticals of New York
- Origin register
- US FDA, United States
- Storage
- Store at 20 • C to 25 • C (68 • F to 77 • F), excursions permitted between 15 • C and 30 • C (59 • F and 86 • F). Protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C10AC04 Colesevelam
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 17 May 2018
- Identifiers
- RxCUI 866910DailyMed set ID 5e50cc0c-03bc-444b-9d15-ea112bc0f91c, f5306376-e7f2-44ad-8250-635b95428a7c, 40d66c9d-ff51-4353-8133-ae3a8eb4f713 +22NDC 27808-190, 0115-1320, 50090-6994 +22Application ANDA209946, ANDA091600, NDA021176 +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 |
|---|---|---|---|
| 1000 tablet, film coated in 1 bottle | 68382-619-10 | Zydus LifesciencesIndia | 11 October 2019 |
| 180 tablet, film coated in 1 bottle | 68382-619-28 | Zydus LifesciencesIndia | 11 October 2019 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 68382-619-77 | Zydus LifesciencesIndia | 11 October 2019 |
| 1000 tablet in 1 bottle | 70771-1368-0 | Zydus LifesciencesIndia | 11 October 2019 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 70771-1368-4 | Zydus LifesciencesIndia | 11 October 2019 |
| 180 tablet in 1 bottle | 70771-1368-8 | Zydus LifesciencesIndia | 11 October 2019 |
| 500 tablet, film coated in 1 bottle | 67877-506-05 | Ascend LaboratoriesIndia | 6 October 2018 |
| 30 tablet, film coated in 1 bottle | 67877-506-30 | Ascend LaboratoriesIndia | 6 October 2018 |
| 180 tablet, film coated in 1 bottle | 67877-506-51 | Ascend LaboratoriesIndia | 6 October 2018 |
| 90 tablet, film coated in 1 bottle | 67877-506-90 | Ascend LaboratoriesIndia | 6 October 2018 |
| 180 tablet in 1 bottle | 43598-230-18 | Dr. Reddy's LaboratoriesIndia | 5 October 2018 |
| 180 tablet, film coated in 1 bottle | 68462-433-18 | Glenmark PharmaceuticalsIndia | 18 May 2018 |
| 90 tablet, film coated in 1 bottle | 68462-433-90 | Glenmark PharmaceuticalsIndia | 18 May 2018 |
| 180 tablet, film coated in 1 bottle | 33342-197-57 | Macleods PharmaceuticalsIndia | 18 April 2025 |
| 180 tablet, film coated in 1 bottle | 69452-158-25 | Bionpharma | 2 December 2019 |
| 180 tablet in 1 bottle | 69452-493-25 | Bionpharma | 12 February 2026 |
| 180 tablet, film coated in 1 bottle | 69452-582-25 | Bionpharma | 30 September 2026 |
| 180 tablet, film coated in 1 bottle | 0115-1320-19 | Amneal Pharmaceuticals of New York | 17 May 2018 |
| 180 tablet in 1 bottle | 27808-190-01 | Cranbury Pharmaceuticals | 19 October 2020 |
| 90 tablet, film coated in 1 bottle | 50090-4371-0 | A-S Medication Solutions | 20 June 2019 |
| 90 tablet, film coated in 1 bottle | 50090-6994-0 | A-S Medication Solutions | 27 December 2023 |
| 90 tablet, film coated in 1 bottle | 50090-6995-0 | A-S Medication Solutions | 27 December 2023 |
| 90 tablet, film coated in 1 bottle | 50090-7459-0 | A-S Medication Solutions | 14 November 2024 |
| 90 tablet, film coated in 1 bottle | 50090-7460-0 | A-S Medication Solutions | 14 November 2024 |
| 90 tablet in 1 bottle | 50090-7604-0 | A-S Medication Solutions | 16 July 2025 |
| 90 tablet in 1 bottle | 50090-7605-0 | A-S Medication Solutions | 16 July 2025 |
| 90 tablet, film coated in 1 bottle | 50090-7811-0 | A-S Medication Solutions | 5 December 2025 |
| 180 tablet, film coated in 1 bottle | 63629-8767-1 | Bryant Ranch Prepack | 6 October 2018 |
| 180 tablet, film coated in 1 bottle | 71335-2905-1 | Bryant Ranch Prepack | 7 November 2025 |
| 180 tablet, film coated in 1 bottle | 72162-1846-2 | Bryant Ranch Prepack | 20 April 2023 |
| 30 blister pack in 1 box, unit-dose / 1 tablet, film coated in 1 blister pack | 60687-385-25 | American Health Packaging | 9 August 2018 |
| 180 tablet in 1 bottle | 51407-336-18 | Golden State Medical Supply | 6 April 2021 |
| 180 tablet, film coated in 1 bottle, plastic | 72789-476-93 | PD-Rx Pharmaceuticals | 23 January 2025 |
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.
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 Colesevelam
Clinical summary
Colesevelam is a bile acid sequestrant indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia, among other approved uses. MedsAcross supplies Colesevelam 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 ColesevelamFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- COLESEVELAM HYDROCHLORIDE prescribing information (A-S Medication Solutions) · U.S. National Library of Medicine, DailyMed
- Cholestagel: European public assessment report (EPAR) · European Medicines Agency
Need Colesevelam 625 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.