Quick answers
- What is Colestipol hydrochloride used for?
- The FDA-approved label (Colestid, Pharmacia & Upjohn Company LLC, October 24, 2024) says: “Since no drug is innocuous, strict attention should be paid to the indications and contraindications, particularly when selecting drugs for chronic long-term use. COLESTID Tablets are indicated as adjunctive therapy to diet for the reduction of elevated serum total and LDL-C in patients with primary hypercholesterolemia (elevated LDL-C) who do not respond adequately to diet. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Colestipol hydrochloride have a boxed warning?
- No. None of the 13 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Colestipol hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Colestipol hydrochloride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Colestipol hydrochloride?
- 10 companies list prescription products of Colestipol hydrochloride in the FDA NDC Directory, including Amneal Pharmaceuticals of New York LLC, Mylan Pharmaceuticals Inc. and Pharmacia & Upjohn Company LLC.
What Colestipol hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Since no drug is innocuous, strict attention should be paid to the indications and contraindications, particularly when selecting drugs for chronic long-term use. COLESTID Tablets are indicated as adjunctive therapy to diet for the reduction of elevated serum total and LDL-C in patients with primary hypercholesterolemia (elevated LDL-C) who do not respond adequately to diet. …
— FDA label: Colestid, Pharmacia & Upjohn Company LLC, effective October 24, 2024. Read the full label on DailyMed →
The FDA has 13 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 13 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet · Suspension · Granule, for suspension |
|---|---|
| Route | Oral |
| Prescription products | 14 in the FDA NDC Directory |
| Brand names | Colestid |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| colestipol hydrochloride 1 g tablet | Generic | $0.6533 per tablet |
| colestipol hydrochloride 1 g tablet, film coated | Generic | $0.6533 per tablet |
| colestipol hydrochloride 5 g/5 g granule, for suspension | Generic | $0.2687 per gram |
NADAC list of November 4, 2026; these prices took effect between August 19, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Amneal Pharmaceuticals of New York LLC3 products
- Mylan Pharmaceuticals Inc.2 products
- Pharmacia & Upjohn Company LLC2 products
- NorthStar Rx LLC1 product
- Zydus Lifesciences Limited1 product
- Edenbridge Pharmaceuticals LLC.1 product
- American Health Packaging1 product
- Zydus Pharmaceuticals USA Inc.1 product
- Ingenus Pharmaceuticals, LLC1 product
- ANI Pharmaceuticals, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA017563 COLESTID, FLAVORED COLESTID | Pfizer | April 4, 1977 | 21, latest April 25, 2018 2018: Labeling · 2014: Labeling · 1996: Manufacturing (CMC) |
| NDA020222 COLESTID | Pfizer | July 19, 1994 | 4, latest May 25, 2017 2017: Labeling · 2014: Labeling · 2002: Manufacturing (CMC) |
Generic approvals (6)
- ANDA077277Impax Labs · May 2, 2006
- ANDA077510Impax Labs · October 24, 2006
- ANDA215223Zydus Pharms · March 10, 2022
- ANDA216517Ani Pharms · March 10, 2023
- ANDA217667Edenbridge Pharms · August 16, 2024
- ANDA217462Riconpharma LLC · December 3, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1048445, 1048447, 1048450, 1048452 |
|---|---|
| SPL set ID of the quoted label | 3e270911-f27b-44d4-b0a2-33506418cc1d |
| FDA labels (SPL) | 13 |
| FDA applications | NDA017563, NDA020222, 6 ANDA |
| Active ingredients (FDA) | COLESTIPOL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Colestid, Pharmacia & Upjohn Company LLC, effective October 24, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →