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Active ingredient

Colesevelam

29 finished FDA listings contain Colesevelam as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
COLESEVELAM HYDROCHLORIDE
Dosage forms
For Suspension, Powder, For Suspension, Tablet, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
15
Strengths listed
3.75 g/1 · 625 mg/1

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 141626

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 021176COSETTE2000-05-262
ANDA 091600IMPAX LABS INC2018-05-162
ANDA 203480GLENMARK PHARMS LTD2018-05-183
ANDA 202190GLENMARK PHARMS LTD2018-07-161
ANDA 210889DR REDDYS2018-10-051
ANDA 209038ALKEM LABS LTD2018-10-057
ANDA 210316ALKEM LABS LTD2019-05-063
ANDA 208670BIONPHARMA2019-09-132
ANDA 207765ZYDUS PHARMS2019-10-072
ANDA 209946ZHEJIANG JINGXIN2020-07-154
ANDA 212886IMPAX2023-01-181
ANDA 204893MACLEODS PHARMS2025-04-181

Official labeling on DailyMed

Showing the 12 most recent of 28 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.