Prescription medicine
Ezetimibe Brand names: Zetia
Ezetimibe (Zetia) is a prescription medicine with an FDA approval on record since 2002. FDA's NDC Directory lists it from 23 generic labelers, and pharmacies paid $0.0667 per ezetimibe 10 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the ezetimibe FDA label on DailyMed (effective November 25, 2025, Organon LLC); the NDA 21445 record on Drugs@FDA; every ezetimibe label on DailyMed.
Highlights of the record
FDA label of November 25, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageZETIA ® is indicated: In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH).
Forms and strengths
- 10 mg
Tablet.
On the market
- Earliest approval on file
- October 25, 2002 Zetia, Organon; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 16 first June 26, 2015; 11 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 24 of which 23 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- April 30, 2026 Zetia tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0667 per tablet Ezetimibe 10 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 74,543 through July 30, 2026
What is ezetimibe used for?
From the label: indications and usageZETIA ® is indicated: In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH). In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH. In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in adults with mixed hyperlipidemia. […]
Conditions named in the indications of ezetimibe's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Dietary Cholesterol Absorption Inhibitor.
Source: FDA drug label (Zetia), Organon LLC, effective November 25, 2025 (SPL set 174e45e0-45bb-48b7-9e60-8f6cfc1d22bb), via openFDA; the full label on DailyMed
Is there a generic for ezetimibe (Zetia)?
The FDA approved the first generic ezetimibe on June 26, 2015. 16 generic applications are approved; 11 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists ezetimibe from 23 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 1 patent for Zetia tablets, the last expiring on April 30, 2026. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2002 earliest approval on file
- 2015 first generic approved
- 2026 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ezetimibe (Zetia)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0667 per Ezetimibe 10 mg tablet, down 6% from $0.0708 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Ezetimibe 10 mg tablet (generic)
- Zetia 10 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ezetimibe 10 mg tablet | Generic | $0.0667 per tablet | $2.00 | -6% |
| Zetia 10 mg tablet | Brand | $13.94 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $418.11 | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the ezetimibe label say about other medicines?
The ezetimibe label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 4 other medicines name ezetimibe. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cholestyramine | drug interactions | Clinical Impact: Concomitant cholestyramine administration decreased the mean exposure of total ezetimibe. This may result in a reduction of efficacy. … lipid-lowering therapy should be considered. ( 7 ) Bile Acid Sequestrants: Cholestyramine combination decreases exposure of ZETIA. |
| Cyclosporine | drug interactions | Cyclosporine Clinical Impact: Concomitant use of ZETIA and cyclosporine increases ezetimibe and cyclosporine concentrations. The degree of increase in ezetimibe exposure may be greater in patients with severe renal insufficiency. Intervention: Monitor cyclosporine concentrations in patients receiving ZETIA and cyclosporine. In patients treated with cyclosporine, weigh the potential effects of the increased exposure to ezetimibe from concomitant … |
| Fenofibrate | contraindications | When used in combination with a statin, fenofibrate, or other LDL-C lowering therapy, ZETIA is contraindicated in patients for whom a statin, fenofibrate, or other LDL-C lowering therapy are contraindicated. |
Other labels that name ezetimibe
Source: FDA drug label (Zetia), Organon LLC, effective November 25, 2025 (SPL set 174e45e0-45bb-48b7-9e60-8f6cfc1d22bb), via openFDA; the full label on DailyMed
What do FAERS reports show for ezetimibe?
The FDA Adverse Event Reporting System holds 74,543 reports that list ezetimibe among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4,305 are coded as a death and 21,966 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ezetimibe?
13 other medicines are given the same way (oral) and in the same FDA class as ezetimibe or labeled mainly for the same use (high cholesterol), the same class first. High cholesterol lists all 25 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Atorvastatin | High cholesterol | 61 labelers | $0.0228 per tablet 10 mg tablet | No current entry |
| Fenofibrate | High cholesterol | 54 labelers | $0.103 per tablet 160 mg tablet | No current entry |
| Lovastatin | High cholesterol | 19 labelers | $0.0436 per tablet 20 mg tablet | No current entry |
| Gemfibrozil | High cholesterol | 27 labelers | $0.104 per tablet 600 mg tablet | A presentation being discontinued |
| Pitavastatin | High cholesterol | 12 labelers | $0.954 per tablet 2 mg tablet | No current entry |
| Cholestyramine | High cholesterol | 15 labelers | $0.834 per packet Cholestyramine packet | No current entry |
| Colesevelam | High cholesterol | 15 labelers | $0.262 per tablet 625 mg tablet | No current entry |
| Niacin | High cholesterol | 13 labelers | $0.193 per tablet 500 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does ezetimibe compare with medicines for the same use?
6 side-by-side pages set ezetimibe beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to ezetimibe
- 13 medicines for the same use
- Other dietary cholesterol absorption inhibitors
- the pharmacologic class, with prices and generics
- Ezetimibe side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other