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Ezetimibe 10 mg Tablet, 30-count — NDC 76333-0170-15 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ezetimibe 10 mg Tablet, 30-count — NDC 76333-170-15 (Billing 76333-0170-15)

by Orient Pharma Co., Ltd. · 30 TABLET in 1 BOTTLE

This is a package of 30 tablets of Ezetimibe 10 mg Tablet from Orient Pharma Co., Ltd., marketed since Jun 2022 and currently FDA-listed.

NDC 76333-0170-15
🏷️ FDA NDC (as labeled) 76333-170-15 billing pads the product segment with a zero
This package
Contains30-count Pack sizes4 compare ↓
Also priced by: Part D plans $0.2167/unit — full pricing hub ↓
Product page 76333-0170-12 Also comes in: 90 tablets 76333-170-14 500 tablets 76333-170-13 1000 tablets 76333-170-12
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 76333-170-15
Product NDC 76333-170
11-digit billing NDC 76333017015
RxCUI 349556
UNII EOR26LQQ24
Application # ANDA215693
SPL Set ID b6e77d9b-a553-63e0-e053-2a95a90a18fe
Established class (EPC) Dietary Cholesterol Absorption Inhibitor
Physiologic effect Decreased Cholesterol Absorption
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-06-30
Route ORAL
Dosage form TABLET
Substance EZETIMIBE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 349556
Why two NDCs? The FDA registers this code as 76333-170-15 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 76333-0170-15. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Dietary Cholesterol Absorption Inhibitor class.

Pharmacologic class Dietary Cholesterol Absorption Inhibitor
Drug family (ATC) Other lipid modifying agents
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📖 What it is MedlinePlus · NLM

Ezetimibe is used along with diet, alone or in combination with another cholesterol-lowering medications (HMG-CoA reductase inhibitors [statins]) to reduce the amount of low-density lipoprotein (LDL) cholesterol ('bad cholesterol') in the blood in adults and children 10 years of age or older who have familial heterozygous hypercholesterolemia (an inherited condition in which cholesterol cannot be removed from the body normally). It is also used along with diet, alone or in combination with other cholesterol-lowering medications (HMG-CoA reductase inhibitors [statins] or fenofibrate) in adults...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Great question. Ezetimibe works in your intestine — it blocks a protein that absorbs cholesterol from your food and bile, so less cholesterol gets into your bloodstream. Statins, o...
  • What exactly does ezetimibe do, and how is it different from a statin?
  • You can take it at whatever time of day works best for you — morning, evening, whatever you'll remember. Food doesn't affect how well it's absorbed, so with or without a meal is fi...
  • Can I take ezetimibe at any time of day, and does it matter if I eat first?
📖 Read our full Ezetimibe guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.2167 $6.50 / 30 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
76333-0170-15 You're viewing this 30 TABLET in 1 BOTTLE 2022-06-30 — Active
76333-0170-12 76333-170-12 Main listing 1000 TABLET in 1 BOTTLE 2023-11-13 — Active
76333-0170-13 76333-170-13 500 TABLET in 1 BOTTLE 2023-11-13 — Active
76333-0170-14 76333-170-14 90 TABLET in 1 BOTTLE 2023-11-13 — Active

You're viewing the smallest of 4 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 30-count package — 30 tablet in 1 bottle.
How does this package differ from NDC 76333-0170-14?
Both are Ezetimibe 10 mg Tablet — the drug itself is identical. This page's package is the 30-count one, while NDC 76333-0170-14 is the 90 tablets package.
What NDC number is used to bill for this package of Ezetimibe 10 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ezetimibe 10 mg 00904-7103-04 Major 30 tablets $0.067 AB Availability likely —
Ezetimibe 10 mg 16714-0813-01 NorthStar 30 tablets $0.067 AB Availability likely —
Ezetimibe 10 mg 50228-0379-05 ScieGen 500 tablets $0.067 AB Availability likely —
Ezetimibe 10 mg 50268-0298-12 AvPAK 20 tablets $0.067 AB Availability likely —
Ezetimibe 10 mg 51660-0200-05 Ohm 500 tablets $0.067 AB Availability likely —
Ezetimibe 10 mg 59651-0052-05 Aurobindo 500 tablets $0.067 AB Availability likely —
Ezetimibe 10 mg 60687-0373-21 American 30 tablets $0.067 AB Availability likely —
Ezetimibe 10 mg 68462-0226-05 Glenmark 500 tablets $0.067 AB Availability likely —
ezetimibe 10 mg 82009-0024-05 Quallent 500 tablets $0.067 AB Availability likely —
Ezetimibe 10 mg 00591-3713-05 Actavis 500 tablets $0.067 AB Discontinued —
Ezetimibe 10 mg 16729-0433-10 Accord 30 tablets $0.071 AB Availability likely —
Ezetimibe 10 mg 00781-5690-05 Sandoz 500 tablets $0.084 AB Discontinued —
Zetia 10 mg 78206-0178-01 Organon 30 tablets $13.937 AB Availability likely —
Ezetimibe 10 mg 10135-0787-05 Marlex 500 tablets — AB FDA listed —
Ezetimibe 10 mg 31722-0628-01 Camber 100 tablets — AB FDA listed —
Ezetimibe 10 mg 33342-0373-07 Macleods 30 tablets — — FDA listed —
Ezetimibe 10 mg 50090-3422-00 A-S 30 tablets — AB FDA listed —
Ezetimibe 10 mg 50090-3657-00 A-S 30 tablets — AB FDA listed —
Ezetimibe 10 mg 50090-6630-00 A-S 30 tablets — AB FDA listed —
Ezetimibe 10 mg 50090-6631-00 A-S 90 tablets — AB FDA listed —
Ezetimibe 10 mg 50090-7099-00 A-S 90 tablets — AB FDA listed —
Ezetimibe 10 mg 50090-7236-00 A-S 90 tablets — AB FDA listed —
Ezetimibe 10 mg 50090-7338-00 A-S 90 tablets — AB FDA listed —
Ezetimibe 10 mg 50090-7339-00 A-S 30 tablets — AB FDA listed —
Ezetimibe 10 mg 50090-7689-00 A-S 90 tablets — AB FDA listed —
Ezetimibe 10 mg 50090-7690-00 A-S 30 tablets — AB FDA listed —
Ezetimibe 10 mg 60429-0982-05 Golden 500 tablets — AB FDA listed —
Ezetimibe 10 mg 63629-7413-01 Bryant 30 tablets — AB FDA listed —
Ezetimibe 10 mg 67877-0490-01 Ascend 100 tablets — AB FDA listed —
ezetimibe 10 mg 68382-0773-01 Zydus 100 tablets — AB FDA listed —
Ezetimibe 10 mg 69238-1154-01 Amneal 1000 tablets — AB FDA listed —
ezetimibe 10 mg 70771-1109-00 Zydus 1000 tablets — AB FDA listed —
Ezetimibe 10 mg 71205-0145-30 Proficient 30 tablets — AB FDA listed —
Ezetimibe 10 mg 71205-0277-30 Proficient 30 tablets — AB FDA listed —
Ezetimibe 10 mg 71335-0684-01 Bryant 30 tablets — AB FDA listed —
Ezetimibe 10 mg 71335-0933-01 Bryant 30 tablets — AB FDA listed —
Ezetimibe 10 mg 71335-1127-01 Bryant 30 tablets — AB FDA listed —
Ezetimibe 10 mg 71335-2123-01 Bryant 30 tablets — AB FDA listed —
Ezetimibe 10 mg 71335-3092-01 Bryant 30 tablets — AB FDA listed —
Ezetimibe 10 mgthis 76333-0170-15 Orient 30 tablets — AB FDA listed —
Ezetimibe 10 mg 82804-0064-30 Proficient 30 tablets — AB FDA listed —
Ezetimibe 10 mg 82804-0211-30 Proficient 30 tablets — AB FDA listed —
ezetimibe 10 mg 48433-0161-03 Safecor 30 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2022
On the market since
Jun 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color white
ShapeOval
ImprintOP;70
Size8 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerOrient Pharma Co., Ltd.
Application holderORIENT PHARMA CO LTD
FDA applicationANDA215693 (ANDA)
Labeler code76333
First marketedJun 2022
Product typeHuman Prescription Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Patient Package Insert 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE Ezetimibe tablet 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.

In combination with a statin, and other LDL-C lowering therapies, to reduce elevated LDL-C levels in adults and in pediatric patients 10 years of age and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the reduction of elevated sitosterol and campesterol levels in adults and in pediatric patients 9 years of age and older with homozygous familial sitosterolemia. When ezetimibe tablet is used in combination with a statin, fenofibrate, or other LDL-C lowering therapies, refer to the Prescribing Information of these products for information on the safe and effective use.

Ezetimibe tablet is indicated ( 1 ): 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.

In combination with a statin, and other LDL-C lowering therapies, to reduce elevated LDL-C levels in adults and in pediatric patients 10 years of age and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the reduction of elevated sitosterol and campesterol levels in adults and in pediatric patients 9 years of age and older with homozygous familial sitosterolemia. When Ezetimibe tablet is used in combination with a statin, fenofibrate, or other LDL-C lowering therapies, refer to the Prescribing Information of these products for information on the safe and effective use ( 1 ).

⏱️ Dosage and Administration 128 words ▾

2 DOSAGE AND ADMINISTRATION The recommended dose of ezetimibe tablet is 10 mg orally once daily, administered with or without food. If as dose is missed, take the missed dose as soon as possible. Do not double the next dose.

Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating ezetimibe tablet. Administer ezetimibe tablet at least 2 hours before or 4 hours after administration of a bile acid sequestrant [ see Drug Interactions ( 7 ) ]. 10-mg orally once daily, with or without food ( 2 ) Administer Ezetimibe tablets either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant.

( 2 ) Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating Ezetimibe tablets. ( 2 )

💊 Dosage Forms and Strengths 30 words ▾

3 DOSAGE FORMS AND STRENGTHS 10-mg tablets are white to off-white, capsule-shaped tablets debossed with "OP" on one side and "70" on other side. Tablets: 10 mg ( 3 )

⛔ Contraindications 153 words ▾

4 CONTRAINDICATIONS Ezetimibe tablet is contraindicated in patients with a known hypersensitivity to ezetimibe or any of the excipients in ezetimibe tablets. Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria have been reported [see Adverse Reactions ( 6.2 )] . When used in combination with a statin, fenofibrate, or other LDL-C lowering therapy, ezetimibe tablet is contraindicated in patients for whom a statin, fenofibrate, or other LDL-C lowering therapy are contraindicated.

Refer to the Prescribing Information of these products for a list of their contraindications [see Warnings and Precautions ( 5.1 )] . Hypersensitivity to ezetimibe or any excipient of ezetimibe tablets. ( 4 ) When used in combination with a statin, fenofibrate, or other LDL-C lowering therapy, Ezetimibe tablet is contraindicated in patients for whom a statin, fenofibrate, or other LDL-C lowering therapy are contraindicated.

Refer to the Prescribing Information of these products for a list of their contraindications. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Risks Associated with Combination Treatment with a Statin, Fenofibrate, or Other LDL-C Lowering Therapies: Refer to the Prescribing Information of these products for a description of their risks including, but not limited to, the warnings and precautions. ( 5.1 ) Liver Enzyme Abnormalities and Monitoring: Increases in serum transaminases have been reported with use of Ezetimibe tablets. Perform liver enzyme testing as clinically indicated and consider withdrawal of Ezetimibe tablet if increases in ALT or AST ≥3 × ULN persist.

( 5.2 ) Skeletal Muscle Effects (e.g., Myopathy and Rhabdomyolysis): Ezetimibe tablets may cause myopathy and rhabdomyolysis. In post-marketing reports, most patients who developed rhabdomyolysis were taking a statin or other agents known to be associated with an increased risk of rhabdomyolysis, such as fibrates. If myopathy is suspected, discontinue Ezetimibe tablets and other concomitant medications, as appropriate.

( 5.3 )

5.1Risks Associated with Combination Treatment with a Statin, Fenofibrate, or Other LDL-C Lowering Therapies If ezetimibe tablet is administered with a statin, fenofibrate, or other LDL-C lowering therapies, refer to the Prescribing Information of these products for a description of their risks including, but not limited to, the warnings and precautions [see Contraindications ( 4 )] .

5.2Liver Enzymes Increases in serum transaminases have been reported with use of ezetimibe tablets [see Adverse Reactions ( 6.1 )] . In controlled clinical combination studies of ezetimibe tablets initiated concurrently with a statin, the incidence of consecutive elevations (≥3 × ULN) in hepatic transaminase levels was 1.3% for patients treated with ezetimibe administered with statins and 0.4% for patients treated with statins alone. Perform liver enzyme testing as clinically indicated and consider withdrawal of ezetimibe tablets if increases in ALT or AST ≥3 × ULN persist.

5.3Myopathy/Rhabdomyolysis Ezetimibe tablets may cause myopathy [muscle pain, tenderness, or weakness associated with elevated creatine kinase (CK)] and rhabdomyolysis [see Adverse Reactions ( 6.1 )] . In post-marketing reports, most patients who developed rhabdomyolysis were taking a statin or other agents known to be associated with an increased risk of rhabdomyolysis, such as fibrates. If myopathy is suspected, discontinue ezetimibe tablets and other concomitant medications, as appropriate.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the label: Liver enzyme abnormalities [see Warnings And Precautions ( 5.2 )] Rhabdomyolysis and myopathy [see Warnings And Precautions ( 5.3 )] Common adverse reactions in clinical trials: o Ezetimibe administered alone (incidence ≥2% and greater than placebo): upper respiratory tract infection, diarrhea, arthralgia, sinusitis, pain in extremity, fatigue, and influenza ( 6.1 ) o Ezetimibe tablets coadministered with a statin (incidence ≥2% and greater than statin alone): nasopharyngitis, myalgia, upper respiratory tract infection, arthralgia, diarrhea, back pain, influenza, pain in extremity, and fatigue ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Orient Pharma Co., Ltd. at +886-5-631-1331/ 1-855-642-2594 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. Monotherapy In 10 double-blind, placebo-controlled clinical trials, 2396 patients with primary hyperlipidemia (age range 9 to 86 years, 50% female, 90% White, 5% Black or African American, 2% Asians, 3% other races; 3% identified as Hispanic or Latino ethnicity) and elevated LDL-C were treated with ezetimibe 10 mg daily for a median treatment duration of 12 weeks (range 0 to 39 weeks).

Adverse reactions reported in ≥2% of patients treated with ezetimibe and at an incidence greater than placebo in placebo-controlled studies of ezetimibere shown in Table 1 . Table 1. Adverse Reactions Occurring ≥2% and Greater than Placebo in Ezetimibe-treated Patients Adverse Reaction Placebo(%) n = 1,159 Ezetimibe 10 mg (%) n = 2,396 Upper respiratory tract infection 2.5

4.3Diarrhea 3.7

4.1Arthralgia 2.2

3.0Sinusitis 2.2

2.8Pain in extremity 2.5

2.7Fatigue 1.5

2.4Influenza 1.5

2.0Combination with a Statin In 28 double-blind, controlled (placebo or active-controlled) clinical trials, 11,308 patients with primary hyperlipidemia (age range 10 to 93 years, 48% female, 85% White, 7% Black or African American, 3% Asians, 5% other races; 4% identified as Hispanic or Latino ethnicity) and elevated LDL-C were treated with ezetimibe 10 mg/day concurrently with or added to on-going statin therapy for a median treatment duration of 8 weeks (range 0 to 112 weeks). The incidence of consecutive increased transaminases (≥3 × ULN) was higher in patients receiving ezetimibe administered with statins (1.3%) than in patients treated with statins alone (0.4%).

Adverse reactions reported in ≥2% of patients treated with ezetimibe + statin and at an incidence greater than statin are shown in Table 2 . Table 2: Adverse Reactions Occurring ≥2% in Ezetimibe-treated Patients Coadministered with a Statin and at an Incidence Greater than Statin Adverse Reaction All Statins (%) n = 9,361 Ezetimibe + All Statins (%) n = 11,308 Nasopharyngitis 3.3

3.7Myalgia 2.7

3.2Upper respiratory tract infection 2.8

2.9Arthralgia 2.4

2.6Diarrhea 2.2

2.5Back pain 2.3

2.4Influenza 2.1

2.2Pain in extremity 1.9

2.1Fatigue 1.6 2.0 *All Statins = all doses of all statins Combination with Fenofibrate This clinical trial involving 625 patients with mixed dyslipidemia (age range 20 to 76 years, 44% female, 79% White, 1% Black or African American, 20% other races; 11% identified as Hispanic or Latino ethnicity) treated for up to 12 weeks and 576 patients treated for up to an additional 48 weeks evaluated coadministration of ezetimibe and fenofibrate. Incidence rates for clinically important elevations (≥3 × ULN, consecutive) in hepatic transaminase levels were 4.5% and 2.7% for fenofibrate monotherapy (n=188) and ezetimibe coadministered with fenofibrate (n=183), respectively, adjusted for treatment exposure.

Co… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Table 3 includes a list of drugs with clinically important drug interactions when administered concomitantly with Ezetimibe tablets and instructions for preventing or managing them. Table 3: Clinically Important Drug Interactions with Ezetimibe tablets Cyclosporine Clinical Impact: Concomitant use of ezetimibe and cyclosporine increases ezetimibe and cyclosporine concentrations. The degree of increase in ezetimibe exposure may be greater in patients with severe renal insufficiency [ see Clinical Pharmacology ( 12.3 )].

Intervention: Monitor cyclosporine concentrations in patients receiving ezetimibe and cyclosporine. In patients treated with cyclosporine, weigh the potential effects of the increased exposure to ezetimibe from concomitant use against the benefits of alterations in lipid levels provided by ezetimibe. Fibrates Clinical Impact: Both fenofibrate and ezetimibe may increase cholesterol excretion into the bile, leading to cholelithiasis.

Co-administration of ezetimibe with fibrates other than fenofibrate is not recommended [ see Adverse Reactions ( 6.1 )]. Intervention: If cholelithiasis is suspected in a patient receiving ezetimibe and fenofibrate, gallbladder studies are indicated, and alternative lipid-lowering therapy should be considered. Bile Acid Sequestrants Clinical Impact: Concomitant cholestyramine administration decreased the mean exposure of total ezetimibe.

This may result in a reduction of efficacy [see Clinical Pharmacology ( 12.3 )]. Intervention: In patients taking a bile acid sequestrant, administer ezetimibe at least 2 hours before or 4 hours after the bile acid sequestrant [see Dosage and Administration ( 2 )]. Cyclosporine: Combination increases exposure of ezetimibe and cyclosporine.

Cyclosporine concentrations should be monitored in patients taking ezetimibe concomitantly. ( 7 ) Fibrates: Coadministration of ezetimibe with fibrates other than fenofibrate is not recommended until use in patients is adequately studied. If cholelithiasis is suspected in a patient receiving ezetimibe and fenofibrate, gallbladder studies are indicated, and alternative lipid-lowering therapy should be considered.

( 7 ) Bile Acid Sequestrants: Cholestyramine combination decreases exposure of ezetimibe. ( 7 ) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 03/2024

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are insufficient data on ezetimibe use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, no adverse developmental effects were observed in pregnant rats and rabbits orally administered ezetimibe during the period of organogenesis at doses that resulted in up to 10 and 150 times, respectively, the human exposure at the MRHD, based on AUC ( see Data ). Ezetimibe tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

When ezetimibe tablets is administered with a statin, refer to the Prescribing Information for the statin. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data Animal Data In oral (gavage) embryo-fetal development studies of ezetimibe conducted in rats (gestation days 6-15) and rabbits (gestation days 7-19), there was no evidence of maternal toxicity or embryolethal effects at the doses tested (250, 500, 1,000 mg/kg/day). In rats, increased incidences of common fetal skeletal findings (extra pair of thoracic ribs, unossified cervical vertebral centra, shortened ribs) were observed at 1,000 mg/kg/day (~10 times the human exposure at 10 mg daily based on AUC 0-24hr for total ezetimibe).

In rabbits treated with ezetimibe, an increased incidence of extra thoracic ribs was observed at 1,000 mg/kg/day (150 times the human exposure at 10 mg daily based on AUC 0-24hr for total ezetimibe). The animal-to-human exposure multiple for total ezetimibe at the no-observed effect level was 6 times for rat and 134 times for rabbit. Fetal exposure to ezetimibe (conjugated and unconjugated) was confirmed in subsequent placental transfer studies conducted using a maternal dose of 1,000 mg/kg/day.

The fetal maternal plasma exposure ratio (total ezetimibe) was 1.5 for rats on gestation day 20 and 0.03 for rabbits on gestation day 22. The effect of ezetimibe on prenatal and postnatal development and maternal function was evaluated in pregnant rats at doses of 100, 300 or 1,000 mg/kg/day from gestation day 6 through lactation day 21. No maternal toxicity or adverse developmental outcomes were observed up to and including the highest dose tested (17 times the human exposure at 10 mg daily based on AUC 0-24hr for total ezetimibe).

Multiple-dose studies of ezetimibe given in combination with statins in rats and rabbits during organogenesis resulted in higher ezetimibe and statin exposures. Reproductive findings occurred at lower doses in combination therapy compared to monotherapy.

8.2Lactation Risk Summary There is no information about the presence of ezetimibe in human milk. Ezetimibe is present in rat milk (see Data) . When a drug is present in animal milk, it is likely that the drug will be present in human milk.

There is no information about the effects of ezetimibe on the breastfed infant or the effects of ezetimibe on milk production. Ezetimibe tablets should not be used in nursing mothers unless the potential benefit justifies the potential risk to the infant. Data Ezetimibe was present in the milk of lactating rats.

The pup to maternal plasma ratio for total ezetimibe was 0.5 on lactation day 12.

8.4Pediatric Use The safety and effectiveness of ezetimibe in combination with a statin as an adjunct to diet to reduce LDL-C have been established in pediatric patients 10 years of age and older with HeFH. Use of ezetimibe tablets for this indication is based on a double-blind, placebo-controlled clinical trial in 248 pediatric patients (142 males and 106 postmenarchal females) 10 years of age and older with HeFH [see Clinical Studies ( 14 )] . In this limited controlled trial, there w… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 23 words ▾

10 OVERDOSAGE In the event of overdose, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Ezetimibe reduces blood cholesterol by inhibiting the absorption of cholesterol by the small intestine. The molecular target of ezetimibe has been shown to be the sterol transporter, Niemann-Pick C1-Like 1 (NPC1L1), which is involved in the intestinal uptake of cholesterol and phytosterols. Ezetimibe localizes at the brush border of the small intestine and inhibits the absorption of cholesterol, leading to a decrease in the delivery of intestinal cholesterol to the liver.

This causes a reduction of hepatic cholesterol stores and an increase in LDL receptors, resulting in clearance of cholesterol from the blood.

12.2Pharmacodynamics Ezetimibe reduces total cholesterol (total-C), LDL-C, apolipoprotein (Apo) B, and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with hyperlipidemia. In a 2-week clinical trial in 18 hypercholesterolemic patients, ezetimibe inhibited intestinal cholesterol absorption by 54%, compared with placebo. Ezetimibe had no clinically meaningful effect on the plasma concentrations of the fat-soluble vitamins A, D, and E (in a trial of 113 patients) and did not impair adrenocortical steroid hormone production (in a trial of 118 patients).

12.3Pharmacokinetics Absorption After oral administration, ezetimibe is absorbed and extensively conjugated to a pharmacologically active phenolic glucuronide (ezetimibe-glucuronide). After a single 10-mg dose of ezetimibe tablet to fasted adults, mean ezetimibe peak plasma concentrations (C max ) of 3.4 to 5.5 ng/mL were attained within 4 to 12 hours (T max ). Ezetimibe-glucuronide mean C max values of 45 to 71 ng/mL were achieved between 1 and 2 hours (T max ).

There was no substantial deviation from dose proportionality between 5 and 20 mg. The absolute bioavailability of ezetimibe cannot be determined, as the compound is virtually insoluble in aqueous media suitable for injection. Effect of Food Concomitant food administration (high-fat or non-fat meals) had no effect on the extent of absorption of ezetimibe when administered as ezetimibe 10-mg tablets.

The C max value of ezetimibe was increased by 38% with consumption of high-fat meals. Distribution Ezetimibe and ezetimibe-glucuronide are highly bound (>90%) to human plasma proteins. Elimination Metabolism Ezetimibe is primarily metabolized in the small intestine and liver via glucuronide conjugation (a phase II reaction) with subsequent biliary and renal excretion.

Minimal oxidative metabolism (a phase I reaction) has been observed in all species evaluated. In humans, ezetimibe is rapidly metabolized to ezetimibe-glucuronide. Ezetimibe and ezetimibe-glucuronide are the major drug-derived compounds detected in plasma, constituting approximately 10 to 20% and 80 to 90% of the total drug in plasma, respectively.

Both ezetimibe and ezetimibe-glucuronide are eliminated from plasma with a half-life of approximately 22 hours for both ezetimibe and ezetimibe-glucuronide. Plasma concentration-time profiles exhibit multiple peaks, suggesting enterohepatic recycling. Excretion Following oral administration of 14 C-ezetimibe (20 mg) to human subjects, total ezetimibe (ezetimibe + ezetimibe-glucuronide) accounted for approximately 93% of the total radioactivity in plasma.

After 48 hours, there were no detectable levels of radioactivity in the plasma. Approximately 78% and 11% of the administered radioactivity were recovered in the feces and urine, respectively, over a 10-day collection period. Ezetimibe was the major component in feces and accounted for 69% of the administered dose, while ezetimibe-glucuronide was the major component in urine and accounted for 9% of the administered dose.

Specific Populations Geriatric Patients In a multiple-dose trial with ezetimibe given 10 mg once daily for 10 days, plasma concentrations for total ezetimibe were about 2-fold higher in older (≥65 years) healthy subjects compared to younger subjects. However, the difference in pl… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 77 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Ezetimibe tablets, USP 10 mg, are white to off-white, capsule-shaped tablets debossed with “OP” on one side and “70” on other side and are supplied as follows: Package Size NDC Bottle of 30 tablets 76333-170-15 Bottle of 90 tablets 76333-170-14 Bottle of 500 tablets 76333-170-13 Bottle of 1000 tablets 76333-170-12 Store Ezetimibe tablets, USP 10 mg at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature.] Protect from moisture.

📋 Description 110 words ▾

11 DESCRIPTION Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The empirical formula is C 24 H 21 F 2 NO 3 .

Its molecular weight is 409.4 and its structural formula is: Ezetimibe is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Ezetimibe has a melting point of about 163°C and is stable at ambient temperature. Ezetimibe is available as a tablet for oral administration containing 10 mg of ezetimibe and the following inactive ingredients: mannitol, microcrystalline cellulose, croscarmellose sodium, povidone, sodium lauryl sulfate, magnesium stearate, anhydrous citric acid. structural formula

💬 Information for Patients 214 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-Approved Patient Labeling ( PATIENT INFORMATION ). Inform patients that ezetimibe may cause liver enzyme elevations [see Warnings and Precautions ( 5.2 )]. Muscle Pain Advise patients that ezetimibe may cause myopathy and rhabdomyolysis.

Inform patients that the risk is also increased when taking certain types of medication and they should discuss all medication, both prescription and over the counter, with their healthcare provider. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever [see Warnings and Precautions ( 5.3 ), and Drug Interactions ( 7 )]. Pregnancy Advise patients to inform their healthcare provider of a known or suspected pregnancy to discuss if ezetimibe should be discontinued [see Use in Specific Populations ( 8.1 )] .

Breast feeding Advise patients who have a lipid disorder and are breastfeeding to discuss the options with their healthcare provider [see Use in Specific Populations ( 8.2 )] . Missed Dose Instruct patients to take ezetimibe only as prescribed. If a dose is missed, it should be taken as soon as possible.

Advise patients not to double their next dose. Finished Drug Product Manufactured by: Orient Pharma Co., Ltd. 8 Kehu 1st Road, Huwei Chen, Yunlin 63247, Taiwan

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption After oral administration, ezetimibe is absorbed and extensively conjugated to a pharmacologically active phenolic glucuronide (ezetimibe-glucuronide). After a single 10-mg dose of ezetimibe tablet to fasted adults, mean ezetimibe peak plasma concentrations (C max ) of 3.4 to 5.5 ng/mL were attained within 4 to 12 hours (T max ). Ezetimibe-glucuronide mean C max values of 45 to 71 ng/mL were achieved between 1 and 2 hours (T max ).

There was no substantial deviation from dose proportionality between 5 and 20 mg. The absolute bioavailability of ezetimibe cannot be determined, as the compound is virtually insoluble in aqueous media suitable for injection. Effect of Food Concomitant food administration (high-fat or non-fat meals) had no effect on the extent of absorption of ezetimibe when administered as ezetimibe 10-mg tablets.

The C max value of ezetimibe was increased by 38% with consumption of high-fat meals. Distribution Ezetimibe and ezetimibe-glucuronide are highly bound (>90%) to human plasma proteins. Elimination Metabolism Ezetimibe is primarily metabolized in the small intestine and liver via glucuronide conjugation (a phase II reaction) with subsequent biliary and renal excretion.

Minimal oxidative metabolism (a phase I reaction) has been observed in all species evaluated. In humans, ezetimibe is rapidly metabolized to ezetimibe-glucuronide. Ezetimibe and ezetimibe-glucuronide are the major drug-derived compounds detected in plasma, constituting approximately 10 to 20% and 80 to 90% of the total drug in plasma, respectively.

Both ezetimibe and ezetimibe-glucuronide are eliminated from plasma with a half-life of approximately 22 hours for both ezetimibe and ezetimibe-glucuronide. Plasma concentration-time profiles exhibit multiple peaks, suggesting enterohepatic recycling. Excretion Following oral administration of 14 C-ezetimibe (20 mg) to human subjects, total ezetimibe (ezetimibe + ezetimibe-glucuronide) accounted for approximately 93% of the total radioactivity in plasma.

After 48 hours, there were no detectable levels of radioactivity in the plasma. Approximately 78% and 11% of the administered radioactivity were recovered in the feces and urine, respectively, over a 10-day collection period. Ezetimibe was the major component in feces and accounted for 69% of the administered dose, while ezetimibe-glucuronide was the major component in urine and accounted for 9% of the administered dose.

Specific Populations Geriatric Patients In a multiple-dose trial with ezetimibe given 10 mg once daily for 10 days, plasma concentrations for total ezetimibe were about 2-fold higher in older (≥65 years) healthy subjects compared to younger subjects. However, the difference in plasma concentrations is not clinically meaningful. Gender In a multiple-dose trial with ezetimibe given 10 mg once daily for 10 days, plasma concentrations for total ezetimibe were slightly higher (<20%) in females than in males.

Race Based on a meta-analysis of multiple-dose pharmacokinetic studies, there were no pharmacokinetic differences between Black and White subjects. Studies in Asian subjects indicated that the pharmacokinetics of ezetimibe were similar to those seen in White subjects. Renal Impairment After a single 10-mg dose of ezetimibe in patients with severe renal disease (n=8; mean CrCl ≤30 mL/min/1.73 m 2 ), the mean AUC values for total ezetimibe, ezetimibe-glucuronide, and ezetimibe were increased approximately 1.5-fold, compared to healthy subjects (n=9).

Hepatic Impairment After a single 10-mg dose of ezetimibe, the mean AUC for total ezetimibe was increased approximately 1.7-fold in patients with mild hepatic impairment (Child-Pugh score 5 to 6), compared to healthy subjects. The mean AUC values for total ezetimibe and ezetimibe were increased approximately 3- to 4-fold and 5- to 6-fold, respectively, in patients with moderate (Child-Pugh score 7 to 9) or severe hepatic impairment (Child-Pugh score 10 to… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 77 words ▾

12.2Pharmacodynamics Ezetimibe reduces total cholesterol (total-C), LDL-C, apolipoprotein (Apo) B, and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with hyperlipidemia. In a 2-week clinical trial in 18 hypercholesterolemic patients, ezetimibe inhibited intestinal cholesterol absorption by 54%, compared with placebo. Ezetimibe had no clinically meaningful effect on the plasma concentrations of the fat-soluble vitamins A, D, and E (in a trial of 113 patients) and did not impair adrenocortical steroid hormone production (in a trial of 118 patients).

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES Primary Hyperlipidemia in Adults Ezetimibe reduces total-C, LDL-C, Apo B, and non-HDL-C in patients with hyperlipidemia. Maximal to near maximal response is generally achieved within 2 weeks and maintained during chronic therapy. Monotherapy In two multicenter, double-blind, placebo-controlled, 12-week trials in 1719 patients (age range 18 to 86 years, 52% females; 91% White, 5% Black or African American, 1% Asian, 3% other races mostly identified as Hispanic or Latino ethnicity) with primary hyperlipidemia, ezetimibe significantly lowered total-C, LDL-C, Apo B, and non-HDL-C compared to placebo (see Table 6 ).

Reduction in LDL-C was consistent across age, sex, and baseline LDL-C. Table 6. Response to Ezetimibe in Patients with Primary Hyperlipidemia (Mean % Change from Untreated Baseline † ) Treatment Group N Total-C LDL-C Apo B Non-HDL-C Trial 1 ‡ Placebo 205 +1 +1 -1 +1 Ezetimibe 622 -12 -18 -15 -16 Trial 2 ‡ Placebo 226 +1 +1 -1 +2 Ezetimibe 666 -12 -18 -16 -16 Pooled Data‡ (Trials 1 & 2) Placebo 431 0 +1 -2 +1 Ezetimibe 1288 -13 -18 -16 -16 † Baseline - on no lipid-lowering drug ‡ Ezetimibe significantly reduced total-C, LDL-C, Apo B, and non-HDL-Cs compared to placebo.

Table 7. Response to Addition of Ezetimibe to On-Going Statin Therapy* in Patients with Hyperlipidemia (Mean % Change from Treated Baseline ¥ ) Treatment (Daily Dose) N Total-C LDL-C Apo B Non-HDL-C On-going Statin + Placebo § 390 -2 -4 -3 -3 On-going Statin + Ezetimibe § 379 -17 -25 -19 -23 * Patients receiving each statin: 40% atorvastatin, 31% simvastatin, 29% others (pravastatin, fluvastatin, cerivastatin, lovastatin) Combination with Statins: Ezetimibe Initiated Concurrently with a Statin ¥ Baseline- on a statin alone. § Ezetimibe + statin significantly reduced total-C, LDL-C, Apo B, and non-HDL-C compared to statin alone.

Combination with Statins: Ezetimibe Initiated Concurrently with a Statin In four multicenter, double-blind, placebo-controlled, 12-week trials, in 2382 (age range 18 to 87 years, 57% female; 88% White, 5% Black or African American, 2% Asian, 5% other races mostly identified as Hispanic or Latino) with hyperlipidemia, ezetimibe or placebo was administered alone or with various doses of atorvastatin, simvastatin, pravastatin, or lovastatin. When all patients receiving ezetimibe with a statin were compared to all those receiving the corresponding statin alone, ezetimibe significantly lowered total-C, LDL-C, Apo B, and non-HDL-C compared to the statin administered alone.

LDL-C reductions induced by ezetimibe were generally consistent across all statins. (See footnote ‡ , Tables 8 to 11.) Table 8. Response to Ezetimibe and Atorvastatin Initiated Concurrently in Patients with Primary Hyperlipidemia (Mean % Change from Untreated Baseline † ) Treatment (Daily Dose) N Total-C LDL-C Apo B Non-HDL-C Placebo 60 +4 +4 +3 +4 Ezetimibe 65 -14 -20 -15 -18 Atorvastatin 10 mg 60 -26 -37 -28 -34 Ezetimibe + Atorvastatin 10 mg 65 -38 -53 -43 -49 Atorvastatin 20 mg 60 -30 -42 -34 -39 Ezetimibe + Atorvastatin 20 mg 62 -39 -54 -44 -50 Atorvastatin 40 mg 66 -32 -45 -37 -41 Ezetimibe + Atorvastatin 40 mg 65 -42 -56 -45 -52 Atorvastatin 80 mg 62 -40 -54 -46 -51 Ezetimibe + Atorvastatin 80 mg 63 -46 -61 -50 -58 Pooled data (All Atorvastatin Dose) ‡ 248 -32 -44 -36 -41 Pooled data (All Ezetimibe + Atorvastatin Doses) ‡ 255 -41 -56 -45 -52 † Baseline- on no lipid-lowering drug ‡ Ezetimibe + all doses of atorvastatin pooled (10 to 80 mg) significantly reduced total-C, LDL-C, Apo B, and non-HDL-C compared to all doses of atorvastatin pooled (10 to 80 mg).

Table 9. Response to Ezetimibe and Simvastatin Initiated Concurrently in Patients with Primary Hyperlipidemia (Mean % Change from Untreated Baseline † ) Treatment (Daily Dose) N Total-C LDL-C Apo B Non-HDL-C Placebo 70 -1 -1 0 -1 Ezetimibe 61 -13 -19 -14 -17 Simvastatin 10 mg 70 -18 -27 -21 -25 Ezetimibe + Simvastatin 10 mg 67 -32 -46 -35 -42 Simvastatin 20 mg 61 -26 -36 -29 -33 Ezetimibe + S… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility A 104-week dietary carcinogenicity study with ezetimibe was conducted in rats at doses up to 1500 mg/kg/day (males) and 500 mg/kg/day (females) (~20 X the human exposure at 10 mg daily based on AUC 0–24hr for total ezetimibe). A 104-week dietary carcinogenicity study with ezetimibe was also conducted in mice at doses up to 500 mg/kg/day (>150 X the human exposure at 10 mg daily based on AUC 0–24hr for total ezetimibe). There were no statistically significant increases in tumor incidences in drug-treated rats or mice.

No evidence of mutagenicity was observed in vitro in a microbial mutagenicity (Ames) test with Salmonella typhimurium and Escherichia coli with or without metabolic activation. No evidence of clastogenicity was observed in vitro in a chromosomal aberration assay in human peripheral blood lymphocytes with or without metabolic activation. In addition, there was no evidence of genotoxicity in the in vivo mouse micronucleus test.

In oral (gavage) fertility studies of ezetimibe conducted in rats, there was no evidence of reproductive toxicity at doses up to 1000 mg/kg/day in male or female rats (~7 X the human exposure at 10 mg daily based on AUC 0–24hr for total ezetimibe).

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility A 104-week dietary carcinogenicity study with ezetimibe was conducted in rats at doses up to 1500 mg/kg/day (males) and 500 mg/kg/day (females) (~20 X the human exposure at 10 mg daily based on AUC 0–24hr for total ezetimibe). A 104-week dietary carcinogenicity study with ezetimibe was also conducted in mice at doses up to 500 mg/kg/day (>150 X the human exposure at 10 mg daily based on AUC 0–24hr for total ezetimibe). There were no statistically significant increases in tumor incidences in drug-treated rats or mice.

No evidence of mutagenicity was observed in vitro in a microbial mutagenicity (Ames) test with Salmonella typhimurium and Escherichia coli with or without metabolic activation. No evidence of clastogenicity was observed in vitro in a chromosomal aberration assay in human peripheral blood lymphocytes with or without metabolic activation. In addition, there was no evidence of genotoxicity in the in vivo mouse micronucleus test.

In oral (gavage) fertility studies of ezetimibe conducted in rats, there was no evidence of reproductive toxicity at doses up to 1000 mg/kg/day in male or female rats (~7 X the human exposure at 10 mg daily based on AUC 0–24hr for total ezetimibe).

📄 Patient Package Insert ~3 min read ▾

PATIENT PACKAGE INSERT Patient Information Ezetimibe Tablets, USP for oral use Read this information carefully before you start taking ezetimibe tablets and each time you get more ezetimibe tablets. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

If you have any questions about ezetimibe tablets, ask your doctor. Only your doctor can determine if ezetimibe tablets are right for you. What is ezetimibe tablet?

Ezetimibe tablet is a medicine used with a cholesterol lowering diet: and with other cholesterol medicines called a statin, or alone (when additional cholesterol lowering treatments are not possible), to lower elevated low-density lipoprotein cholesterol (LDL-C) or bad cholesterol in adults with primary hyperlipidemia (too many fats in your blood), including heterozygous familial hypercholesterolemia (HeFH). HeFH is an inherited condition that causes high levels of bad cholesterol. and with a statin to lower LDL-C in adults and children 10 years of age and older with HeFH. and with a medicine called fenofibrate to lower elevated LDL-C in adults with mixed hyperlipidemia. to lower elevated sitosterol and campesterol levels in adults and in children 9 years of age and older with homozygous familial sitosterolemia (a rare inherited condition that prevents the body from getting rid of cholesterol from plants).

Ezetimibe tablet is also used: with a statin and other cholesterol lowering treatments to lower elevated LDL-C levels in adults and patients 10 years of age and older with homozygous familial hypercholesterolemia (HoFH). HoFH is an inherited condition that causes high levels of bad cholesterol. The safety and effectiveness of ezetimibe tablet has not been established in children: younger than 10 years of age with HeFH or HoFH. younger than 9 years of age with homozygous familial sitosterolemia. with other types of hyperlipemia.

Do not take ezetimibe tablets: if you are allergic to ezetimibe or any of the ingredients in ezetimibe tablets. See the end of this Patient Information leaflet for a complete list of ingredients in ezetimibe tablets. Stop using Ezetimibe tablets and get medical help right away if you have symptoms of a serious allergic reaction including: ° swelling of the face, tongue, or throat ° difficulty breathing or swallowing ° fainting or feeling dizzy ° very fast heartbeat ° severe skin rash, hives, and itching ° flu-like symptoms including fever, sore throat, cough, tiredness, and joint pain with certain statins, fenofibrate, or other LDL-C lowering medicines if your healthcare provider has told you not to take them.

Before you take ezetimibe tablets, tell your healthcare provider about all your medical conditions, including if you: have liver problems. Ezetimibe tablets may not be right for you. are pregnant or plan to become pregnant. It is not known if ezetimibe tablets will harm your unborn baby.

You and your healthcare provider should decide if you will take ezetimibe tablets while you are pregnant. are breastfeeding. It is not known if ezetimibe tablets passes into your breast milk. You and your healthcare provider should decide the best way to feed your baby if you take ezetimibe tablets.

Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Talk to your healthcare provider before you start taking any new medicines. Taking ezetimibe tablets with certain other medicines may affect each other causing side effects.

Ezetimibe tablets may affect the way other medicines work, and other medicines may affect how ezetimibe tablets works. Especially tell your healthcare provider if you take: cyclosporine (a medicine for your immune system) fibrates (medicine for lowering cholesterol) bile acid sequestrants (medicine for lowering LDL-C) Ask your healthcare provider or pharmacist for a list of medicines if you are… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 33 words ▾

RECENT MAJOR CHANGES Indications and Usage ( 1 ) 7/2023 Dosage and Administration ( 2 ) 7/2023 Contraindications ( 4 ) 7/2023 Warnings and Precautions ( 5.1 , 5.2 , 5.3 ) 7/2023

📄 Package Label / Principal Display Panel 79 words ▾

PRINCIPAL DISPLAY PANEL NDC 76333-170-15 Ezetimibe Tablets USP 10 mg Rx Only Bottles of 30 Tablets Orient Pharma Co., Ltd. NDC 76333-170-14 Ezetimibe Tablets USP 10 mg Rx Only Bottles of 90 Tablets Orient Pharma Co., Ltd. NDC 76333-170-13 Ezetimibe Tablets USP 10 mg Rx Only Bottles of 500 Tablets Orient Pharma Co., Ltd.

NDC 76333-170-12 Ezetimibe Tablets USP 10 mg Rx Only Bottles of 1000 Tablets Orient Pharma Co., Ltd. Bottle Label NDC 76333-170-14 NDC 76333-170-13 NDC 76333-170-12

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Ezetimibe — the program that covers self-administered drugs. 15 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Ezetimibe. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$72.21M
Claims incl. refills
2.9M
Beneficiaries
2.4M
Spend / beneficiary
$30.57
Spend / claim
$25.13
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Orient Pharma Co., Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 90 tablets (76333-0170-14), 500 tablets (76333-0170-13), 1000 tablets (76333-0170-12). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Orient Pharma Co., Ltd. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 76333-0111-15 · Orient 76336-0080-60 · HRA →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.