Quick answers
- What is Ezetimibe used for?
- The FDA-approved label (Zetia, Organon LLC, November 25, 2025) says: “ZETIA ® 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). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ezetimibe have a boxed warning?
- No. None of the 40 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Ezetimibe?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ezetimibe been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Ezetimibe?
- 24 companies list prescription products of Ezetimibe in the FDA NDC Directory, including A-S Medication Solutions, Bryant Ranch Prepack and Proficient Rx LP.
What Ezetimibe is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ZETIA ® 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). …
— FDA label: Zetia, Organon LLC, effective November 25, 2025. Read the full label on DailyMed →
The FDA has 40 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.
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 40 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 42 in the FDA NDC Directory |
| Brand names | Zetia |
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 |
|---|---|---|
| ezetimibe 10 mg tablet | Generic | $0.0704 per tablet |
| ezetimibe 10 mg tablet | Brand: Zetia | $13.94 per tablet |
NADAC list of November 4, 2026; these prices took effect on 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.
- A-S Medication Solutions11 products
- Bryant Ranch Prepack6 products
- Proficient Rx LP4 products
- Organon LLC1 product
- Marlex Pharmaceuticals, Inc.1 product
- Zydus Pharmaceuticals USA Inc.1 product
- NorthStar Rx LLC1 product
- Glenmark Pharmaceuticals Inc., USA1 product
- Quallent Pharmaceuticals Health LLC1 product
- AvPAK1 product
- Amneal Pharmaceuticals NY LLC1 product
- Zydus Lifesciences Limited1 product
- Accord Healthcare Inc.1 product
- Macleods Pharmaceuticals Limited1 product
- Orient Pharma Co., Ltd.1 product
- Major Pharmaceuticals1 product
- Camber Pharmaceuticals, Inc.1 product
- Ohm Laboratories Inc.1 product
- Golden State Medical Supply, Inc.1 product
- Safecor Health LLC1 product
- Ascend Laboratories, LLC1 product
- Aurobindo Pharma Limited1 product
- American Health Packaging1 product
- ScieGen 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 |
|---|---|---|---|
| NDA021445 ZETIA | Organon | October 25, 2002 | 28, latest February 21, 2024 2024: Labeling · 2023: Labeling · 2019: Labeling |
Generic approvals (13)
- ANDA078560Glenmark Pharms Ltd · June 26, 2015
- ANDA200831Watson Labs Inc · June 12, 2017
- ANDA203931Sandoz · June 12, 2017
- ANDA204331Zydus Pharms · June 12, 2017
- ANDA207311Ohm Labs Inc · June 12, 2017
- ANDA208803Amneal Pharms Co · June 12, 2017
- ANDA209838Aurobindo Pharma · August 25, 2017
- ANDA209234Alkem Labs Ltd · December 21, 2017
- ANDA211550Accord Hlthcare · October 26, 2018
- ANDA210673Sciegen Pharms · October 23, 2020
- ANDA210859Hetero Labs Ltd III · July 26, 2022
- ANDA215693Orient Pharma · September 13, 2022
- ANDA211159Macleods Pharms · April 29, 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) | 349556, 352304 |
|---|---|
| SPL set ID of the quoted label | 174e45e0-45bb-48b7-9e60-8f6cfc1d22bb |
| FDA labels (SPL) | 40 |
| FDA applications | NDA021445, 13 ANDA |
| Active ingredients (FDA) | EZETIMIBE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Zetia, Organon LLC, effective November 25, 2025; 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 →