Medicine
Colesevelam 3.75 g powder for oral suspension
Colesevelam 3.75 g powder for oral suspension 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 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to…
Key facts
- Active ingredient (INN)
- Colesevelam
- Brand
- Sold under the generic name
- Strength
- 3.75 g
- Dosage form
- Powder for oral suspension
- Route
- Oral
- Packs
- 30 powder, 30 packets and 2 more
- Manufacturers
- Ascend LaboratoriesIndiaGlenmark PharmaceuticalsIndiaBryant Ranch PrepackAmneal Pharmaceuticals of New York
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (68° to 77°F), excursions permitted between 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
- C10AC04 Colesevelam
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 16 July 2018
- Identifiers
- RxCUI 866905DailyMed set ID 652fbd7b-2702-4db6-8691-be93c61bd9d6, dbed6967-b261-44a1-bee4-638810e2efe9, f33fbf30-2486-49a7-bbe8-0ddfb4b9b786 +2NDC 63629-8860, 72162-1847, 0115-1864 +2Application ANDA210316, ANDA212886, ANDA202190
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 powder, for suspension in 1 packet | 67877-523-30 | Ascend LaboratoriesIndia | 9 May 2019 |
| 30 packet in 1 box / 1 powder, for suspension in 1 packet | 68462-620-30 | Glenmark PharmaceuticalsIndia | 16 July 2018 |
| 30 packet in 1 carton / 1 for suspension in 1 packet | 0115-1864-18 | Amneal Pharmaceuticals of New York | 20 January 2023 |
| 30 packet in 1 carton / 1 powder, for suspension in 1 packet | 63629-8860-1 | Bryant Ranch Prepack | 19 August 2022 |
| 30 powder, for suspension in 1 packet | 72162-1847-2 | Bryant Ranch Prepack | 12 March 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.
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 3.75 g powder for oral suspension 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.