Active ingredient
Colestipol
14 finished FDA listings contain Colestipol as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- COLESTIPOL HYDROCHLORIDE
- Dosage forms
- Granule, For Suspension, Suspension, Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 10
- Strengths listed
- 1 g/1 · 5 g/1 · 5 g/5g
- Brand names in FDA listings
- Colestid
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2685
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.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 017563 | PFIZER | 1977-04-04 | 2 |
| NDA 020222 | PFIZER | 1994-07-19 | 2 |
| ANDA 077277 | IMPAX LABS | 2006-05-02 | 2 |
| ANDA 077510 | IMPAX LABS | 2006-10-24 | 2 |
| ANDA 215223 | ZYDUS PHARMS | 2022-03-10 | 2 |
| ANDA 216517 | ANI PHARMS | 2023-03-10 | 2 |
| ANDA 217667 | EDENBRIDGE PHARMS | 2024-08-16 | 1 |
| ANDA 217462 | RICONPHARMA LLC | 2024-12-03 | 1 |
Official labeling on DailyMed
- COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC] · version 1 · 2026-09-02
- COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] · version 16 · 2026-07-13
- COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [INGENUS PHARMACEUTICALS, LLC] · version 2 · 2025-11-17
- COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] · version 5 · 2025-11-17
- COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [ANI PHARMACEUTICALS, INC.] · version 3 · 2025-09-22
- COLESTIPOL HYDROCHLORIDE TABLET [EDENBRIDGE PHARMACEUTICALS LLC.] · version 7 · 2025-06-02
- COLESTIPOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.] · version 12 · 2025-05-15
- COLESTIPOL HYDROCHLORIDE GRANULE, FOR SUSPENSION [MYLAN PHARMACEUTICALS INC.] · version 11 · 2025-05-09
- COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] · version 5 · 2024-12-02
- COLESTID (COLESTIPOL HYDROCHLORIDE) TABLET [PHARMACIA & UPJOHN COMPANY LLC] · version 15 · 2024-10-28
- COLESTID (COLESTIPOL HYDROCHLORIDE) GRANULE, FOR SUSPENSION FLAVORED COLESTID (COLESTIPOL HYDROCHLORIDE) GRANULE, FOR SUSPENSION [PHARMACIA & UPJOHN COMPANY LLC] · version 14 · 2024-07-01
- COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] · version 4 · 2024-02-20
Showing the 12 most recent of 13 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.