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Ezetimibe 10 mg Tablet, 60-count — NDC 71205-0277-60 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, 60-count — NDC 71205-277-60 (Billing 71205-0277-60)

by Proficient Rx LP · 60 TABLET in 1 BOTTLE

This is a package of 60 tablets of Ezetimibe 10 mg Tablet from Proficient Rx LP, marketed since Dec 2017 and currently FDA-listed.

NDC 71205-0277-60
🏷️ FDA NDC (as labeled) 71205-277-60 billing pads the product segment with a zero
This package
Contains60-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.2167/unit — full pricing hub ↓
Product page 71205-0277-30 Also comes in: 30 tablets 71205-277-30 90 tablets 71205-277-90
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) 71205-277-60
Product NDC 71205-277
11-digit billing NDC 71205027760
RxCUI 349556
UNII EOR26LQQ24
UPC 0371205277307
Application # ANDA209234
SPL Set ID fbbe54c3-59a1-436c-aba8-188ba7ca70e0
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 2017-12-23
Route ORAL
Dosage form TABLET
Substance EZETIMIBE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 39300030000320
GPI class Ezetimibe
GCN Seq No 051214
GCN 18387
HICL code 024459
Ingredient (HICL) Ezetimibe
HIC1 code M
Therapeutic class — broad (HIC1) Blood
HIC2 code M4
Therapeutic class — intermediate (HIC2) Affect Blood Lipids/Sugar/Amino Acids
HIC3 code M4E
Therapeutic class — specific (HIC3) Lipotropics
AHFS code 24:06.05.00
AHFS class Cholesterol Absorption Inhibitors
FDB label name EZETIMIBE 10 MG TABLET
FDB brand name Ezetimibe
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 051214
  • GCN: 18387
  • GPI-14 (Medi-Span): 39300030000320
  • HICL (First Databank): 024459
  • AHFS class code: 24:06.05.00
  • RxCUI (RxNorm): 349556
Why two NDCs? The FDA registers this code as 71205-277-60 — 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 → 71205-0277-60. 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

Label name EZETIMIBE 10 MG TABLET Ingredient Ezetimibe
📗 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 $13.00 / 60 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
71205-0277-30 71205-277-30 Main listing 30 TABLET in 1 BOTTLE 2019-05-01 — Active
71205-0277-60 You're viewing this 60 TABLET in 1 BOTTLE 2019-05-01 — Active
71205-0277-90 71205-277-90 90 TABLET in 1 BOTTLE 2019-05-01 — Active

You're viewing one of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 60-count package — 60 tablet in 1 bottle.
How does this package differ from NDC 71205-0277-30?
Both are Ezetimibe 10 mg Tablet — the drug itself is identical. This page's package is the 60-count one, while NDC 71205-0277-30 is the 30 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 mgthis 71205-0277-60 Proficient 60 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 mg 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

🏛️
2017
On the market since
Dec 2017
📍
2026
Currently FDA-listed
9 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
ImprintA25
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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 68401960MK
    Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.

7 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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

LabelerProficient Rx LP
Application holderALKEM LABORATORIES LTD
FDA applicationANDA209234 (ANDA)
Labeler code71205
First marketedDec 2017
Product typeHuman Prescription Drug
Portfolio1,729 products on file
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. 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 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS & USAGE Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Ezetimibe Tablet is an inhibitor of intestinal cholesterol (and related phytosterol) absorption indicated as an adjunct to diet to: • Reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with primary hyperlipidemia, alone or in combination with an HMG-CoA reductase inhibitor (statin) (1.1) • Reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with mixed hyperlipidemia in combination with fenofibrate (1.1) • Reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), in combination with atorvastatin or simvastatin (1.2) • Reduce elevated sitosterol and campesterol in patients with homozygous sitosterolemia (phytosterolemia) (1.3) Limitations of Use ( 1.4 ) • The effect of Ezetimibe Tablets on cardiovascular morbidity and mortality has not been determined. • Ezetimibe Tablets has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.

1.1Primary Hyperlipidemia Monotherapy Ezetimibe Tablets, administered alone, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia. Combination Therapy with HMG-CoA Reductase Inhibitors (Statins) Ezetimibe Tablets, administered in combination with a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin), is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia.

Combination Therapy with Fenofibrate Ezetimibe Tablets, administered in combination with fenofibrate, is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, and non-HDL-C in adult patients with mixed hyperlipidemia.

1.2Homozygous Familial Hypercholesterolemia (HoFH) The combination of Ezetimibe Tablets and atorvastatin or simvastatin is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.

1.3Homozygous Sitosterolemia Ezetimibe Tablet is indicated as adjunctive therapy to diet for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia.

1.4Limitations of Use The effect of Ezetimibe Tablets on cardiovascular morbidity and mortality has not been determined. Ezetimibe Tablets has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE & ADMINISTRATION • One 10-mg tablet once daily, with or without food ( 2.1 ) • Dosing of Ezetimibe Tablets should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant. ( 2.3 , 7.4 )

2.1General Dosing Information The recommended dose of Ezetimibe Tablets is 10 mg once daily. Ezetimibe Tablets can be administered with or without food.

2.2Concomitant Lipid-Lowering Therapy Ezetimibe Tablets may be administered with a statin (in patients with primary hyperlipidemia) or with fenofibrate (in patients with mixed hyperlipidemia) for incremental effect. For convenience, the daily dose of Ezetimibe Tablets may be taken at the same time as the statin or fenofibrate, according to the dosing recommendations for the respective medications.

2.3Co-Administration with Bile Acid Sequestrants Dosing of Ezetimibe Tablets should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant [see Drug Interactions ( 7.4 )] .

2.4Patients with Hepatic Impairment No dosage adjustment is necessary in patients with mild hepatic impairment [see Warnings and Precautions ( 5.4 )].

2.5Patients with Renal Impairment No dosage adjustment is necessary in patients with renal impairment [see Clinical Pharmacology ( 12.3 )]. When given with simvastatin in patients with moderate to severe renal impairment (estimated glomerular filtration rate <60 mL/min/1.73 m 2 ), doses of simvastatin exceeding 20 mg should be used with caution and close monitoring [see Use in Specific Populations ( 8.6 )].

2.6Geriatric Patients No dosage adjustment is necessary in geriatric patients [see Clinical Pharmacology ( 12.3 )].

💊 Dosage Forms and Strengths 37 words ▾

3 DOSAGE FORMS & STRENGTHS 10-mg tablets are white to off white capsule shaped, flat faced, beveled edge tablets, debossed with “A25ˮ on one side and plain on other side. • Tablets: 10 mg ( 3 )

⛔ Contraindications ~1 min read ▾

4 CONTRAINDICATIONS Ezetimibe Tablet is contraindicated in the following conditions: • The combination of Ezetimibe Tablets with a statin is contraindicated in patients with active liver disease or unexplained persistent elevations in hepatic transaminase levels. • Women who are pregnant or may become pregnant. Because statins decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, Ezetimibe Tablets in combination with a statin may cause fetal harm when administered to pregnant women.

Additionally, there is no apparent benefit to therapy during pregnancy, and safety in pregnant women has not been established. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus and the lack of known clinical benefit with continued use during pregnancy. [See Use in Specific Populations ( 8.1 ).] • Nursing mothers. Because statins may pass into breast milk, and because statins have the potential to cause serious adverse reactions in nursing infants, women who require Ezetimibe Tablets treatment in combination with a statin should be advised not to nurse their infants [see Use in Specific Populations ( 8.3 )]. • Patients with a known hypersensitivity to any component of this product.

Hypersensitivity reactions including anaphylaxis, angioedema, rash and urticaria have been reported with Ezetimibe Tablets [see Adverse Reactions ( 6.2 )] . • Statin contraindications apply when Ezetimibe Tablet is used with a statin: • Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels ( 4 , 5.2 ) • Women who are pregnant or may become pregnant ( 4 , 8.1 ) • Nursing mothers ( 4 , 8.3 ) • Known hypersensitivity to product components ( 4 , 6.2 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Ezetimibe Tablet is not recommended in patients with moderate or severe hepatic impairment. ( 5.4 , 8.7 , 12.3 ) • Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminase can occur when Ezetimibe Tablet is added to a statin. Therefore, when Ezetimibe Tablet is added to statin therapy, monitor hepatic transaminase levels before and during treatment according to the recommendations for the individual statin used.

( 5.2 ) • Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): • Cases of myopathy and rhabdomyolysis have been reported in patients treated with Ezetimibe Tablets co-administered with a statin and with Ezetimibe Tablets administered alone. Risk for skeletal muscle toxicity increases with higher doses of statin, advanced age (>65), hypothyroidism, renal impairment, and depending on the statin used, concomitant use of other drugs. ( 5.3 , 6.2 )

5.1Use with Statins or Fenofibrate Concurrent administration of Ezetimibe Tablets with a specific statin or fenofibrate should be in accordance with the product labeling for that medication.

5.2Liver Enzymes In controlled clinical monotherapy studies, the incidence of consecutive elevations (≥3 x the upper limit of normal [ULN]) in hepatic transaminase levels was similar between Ezetimibe Tablets (0.5%) and placebo (0.3%). In controlled clinical combination studies of Ezetimibe Tablets initiated concurrently with a statin, the incidence of consecutive elevations (≥3 x ULN) in hepatic transaminase levels was 1.3% for patients treated with Ezetimibe Tablets administered with statins and 0.4% for patients treated with statins alone.

These elevations in transaminases were generally asymptomatic, not associated with cholestasis, and returned to baseline after discontinuation of therapy or with continued treatment. When Ezetimibe Tablet is co-administered with a statin, liver tests should be performed at initiation of therapy and according to the recommendations of the statin. Should an increase in ALT or AST ≥3 x ULN persist, consider withdrawal of Ezetimibe Tablets and/or the statin.

5.3Myopathy/Rhabdomyolysis In clinical trials, there was no excess of myopathy or rhabdomyolysis associated with Ezetimibe Tablets compared with the relevant control arm (placebo or statin alone). However, myopathy and rhabdomyolysis are known adverse reactions to statins and other lipid-lowering drugs. In clinical trials, the incidence of creatine phosphokinase (CPK) >10 x ULN was 0.2% for Ezetimibe Tablets vs.

0.1% for placebo, and 0.1% for Ezetimibe Tablets co-administered with a statin vs. 0.4% for statins alone. Risk for skeletal muscle toxicity increases with higher doses of statin, advanced age (>65), hypothyroidism, renal impairment, and depending on the statin used, concomitant use of other drugs.

In post-marketing experience with Ezetimibe Tablets, cases of myopathy and rhabdomyolysis have been reported. Most patients who developed rhabdomyolysis were taking a statin prior to initiating Ezetimibe Tablets. However, rhabdomyolysis has been reported with Ezetimibe Tablets monotherapy and with the addition of Ezetimibe Tablets to agents known to be associated with increased risk of rhabdomyolysis, such as fibrates.

Ezetimibe Tablets and any statin or fibrate that the patient is taking concomitantly should be immediately discontinued if myopathy is diagnosed or suspected. The presence of muscle symptoms and a CPK level >10 x the ULN indicates myopathy.

5.4Hepatic Impairment Due to the unknown effects of the increased exposure to ezetimibe in patients with moderate to severe hepatic impairment, Ezetimibe Tablet is not recommended in these patients. [See Clinical Pharmacology ( 12.3 ).]

🤒 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 )] Monotherapy Studies: In the Ezetimibe Tablets controlled clinical trials database (placebo-controlled) of 2396 patients with a median treatment duration of 12 weeks (range 0 to 39 weeks), 3.3% of patients on Ezetimibe Tablets and 2.9% of patients on placebo discontinued due to adverse reactions.

The most common adverse reactions in the group of patients treated with Ezetimibe Tablets that led to treatment discontinuation and occurred at a rate greater than placebo were: • Arthralgia (0.3%) • Dizziness (0.2%) • Gamma-glutamyltransferase increased (0.2%) The most commonly reported adverse reactions (incidence ≥2% and greater than placebo) in the Ezetimibe Tablets monotherapy controlled clinical trial database of 2396 patients were: upper respiratory tract infection (4.3%), diarrhea (4.1%), arthralgia (3.0%), sinusitis (2.8%), and pain in extremity (2.7%).

Statin Co-Administration Studies: In the Ezetimibe Tablets + statin controlled clinical trials database of 11,308 patients with a median treatment duration of 8 weeks (range 0 to 112 weeks), 4.0% of patients on Ezetimibe Tablets + statin and 3.3% of patients on statin alone discontinued due to adverse reactions. The most common adverse reactions in the group of patients treated with Ezetimibe Tablets + statin that led to treatment discontinuation and occurred at a rate greater than statin alone were: • Alanine aminotransferase increased (0.6%) • Myalgia (0.5%) • Fatigue, aspartate aminotransferase increased, headache, and pain in extremity (each at 0.2%) The most commonly reported adverse reactions (incidence ≥2% and greater than statin alone) in the Ezetimibe Tablets + statin controlled clinical trial database of 11,308 patients were: nasopharyngitis (3.7%), myalgia (3.2%), upper respiratory tract infection (2.9%), arthralgia (2.6%) and diarrhea (2.5%). • Common adverse reactions in clinical trials: • Ezetimibe Tablets co-administered with a statin (incidence ≥2% and greater than statin alone): • nasopharyngitis, myalgia, upper respiratory tract infection, arthralgia, and diarrhea ( 6 ) • Ezetimibe Tablets administered alone (incidence ≥2% and greater than placebo): • Upper respiratory tract infection, diarrhea, arthralgia, sinusitis, and pain in extremity ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-ASC-RX01 (877-272-7901) 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% women, 90% Caucasians, 5% Blacks, 3% Hispanics, 2% Asians) and elevated LDL-C were treated with Ezetimibe Tablets 10 mg/day for a median treatment duration of 12 weeks (range 0 to 39 weeks).

Adverse reactions reported in ≥2% of patients treated with Ezetimibe Tablets and at an incidence greater than placebo in placebo-controlled studies of Ezetimibe Tablets, regardless of causality assessment, are shown in Table 1. TABLE 1: Clinical Adverse Reactions Occurring in ≥ 2% of Patients Treated with Ezetimibe Tablets and at an Incidence Greater than Placebo, Regardless of Causality Body System/Organ Class Adverse Reaction Ezetimibe Tablets 10 mg (%) n = 2396 Placebo (%) n = 1159 Gastrointestinal disorders Diarrhea 4.1

3.7General disorders and administration site conditions Fatigue 2.4

1.5Infections and infestations Influenza 2.0

1.5Sinusitis 2.8

2.2 Upper respiratory tract inf…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS [See Clinical Pharmacology ( 12.3 ).] Cyclosporine: Combination increases exposure of Ezetimibe Tablets and cyclosporine. Cyclosporine concentrations should be monitored in patients taking Ezetimibe Tablets concomitantly. ( 7.1 , 12.3 ) Fenofibrate: Combination increases exposure of Ezetimibe Tablets.

If cholelithiasis is suspected in a patient receiving Ezetimibe Tablets and fenofibrate, gallbladder studies are indicated and alternative lipid-lowering therapy should be considered. ( 6.1 , 7.3 ) Fibrates: Co-administration of Ezetimibe Tablets with fibrates other than fenofibrate is not recommended until use in patients is adequately studied. ( 7.2 ) Cholestyramine: Combination decreases exposure of Ezetimibe Tablets.

( 2.3 , 7.4 , 12.3 )

7.1Cyclosporine Caution should be exercised when using Ezetimibe Tablets and cyclosporine concomitantly due to increased exposure to both ezetimibe and cyclosporine. Cyclosporine concentrations should be monitored in patients receiving Ezetimibe Tablets and cyclosporine. The degree of increase in ezetimibe exposure may be greater in patients with severe renal insufficiency.

In patients treated with cyclosporine, the potential effects of the increased exposure to ezetimibe from concomitant use should be carefully weighed against the benefits of alterations in lipid levels provided by ezetimibe.

7.2Fibrates The efficacy and safety of co-administration of ezetimibe with fibrates other than fenofibrate have not been studied. Fibrates may increase cholesterol excretion into the bile, leading to cholelithiasis. In a preclinical study in dogs, ezetimibe increased cholesterol in the gallbladder bile [see Nonclinical Toxicology ( 13.2 )] .

Co-administration of Ezetimibe Tablets with fibrates other than fenofibrate is not recommended until use in patients is adequately studied.

7.3Fenofibrate If cholelithiasis is suspected in a patient receiving Ezetimibe Tablets and fenofibrate, gallbladder studies are indicated and alternative lipid-lowering therapy should be considered [see Adverse Reactions ( 6.1 ) and the product labeling for fenofibrate] .

7.4Cholestyramine Concomitant cholestyramine administration decreased the mean area under the curve (AUC) of total ezetimibe approximately 55%. The incremental LDL-C reduction due to adding ezetimibe to cholestyramine may be reduced by this interaction.

7.5Coumarin Anticoagulants If ezetimibe is added to warfarin, a coumarin anticoagulant, the International Normalized Ratio (INR) should be appropriately monitored.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Category C: There are no adequate and well-controlled studies of ezetimibe in pregnant women. Ezetimibe should be used during pregnancy only if the potential benefit justifies the risk to the fetus. In oral (gavage) embryo-fetal development studies of ezetimibe conducted in rats and rabbits during organogenesis, there was no evidence of embryolethal effects at the doses tested (250, 500, 1000 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 1000 mg/kg/day (~10 x 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 1000 mg/kg/day (150 x the human exposure at 10 mg daily based on AUC 0-24hr for total ezetimibe). Ezetimibe crossed the placenta when pregnant rats and rabbits were given multiple oral doses.

Multiple-dose studies of ezetimibe given in combination with statins in rats and rabbits during organogenesis result in higher ezetimibe and statin exposures. Reproductive findings occur at lower doses in combination therapy compared to monotherapy. All statins are contraindicated in pregnant and nursing women.

When Ezetimibe Tablet is administered with a statin in a woman of childbearing potential, refer to the pregnancy category and product labeling for the statin. [See Contraindications ( 4 ).]

8.3Nursing Mothers It is not known whether ezetimibe is excreted into human breast milk. In rat studies, exposure to total ezetimibe in nursing pups was up to half of that observed in maternal plasma. Because many drugs are excreted in human milk, caution should be exercised when Ezetimibe Tablet is administered to a nursing woman.

Ezetimibe Tablets should not be used in nursing mothers unless the potential benefit justifies the potential risk to the infant.

8.4Pediatric Use The effects of Ezetimibe Tablets co-administered with simvastatin (n=126) compared to simvastatin monotherapy (n=122) have been evaluated in adolescent boys and girls with heterozygous familial hypercholesterolemia (HeFH). In a multicenter, double-blind, controlled study followed by an open-label phase, 142 boys and 106 postmenarchal girls, 10 to 17 years of age (mean age 14.2 years, 43% females, 82% Caucasians, 4% Asian, 2% Blacks, 13% multi-racial) with HeFH were randomized to receive either Ezetimibe Tablets co-administered with simvastatin or simvastatin monotherapy.

Inclusion in the study required 1) a baseline LDL-C level between 160 and 400 mg/dL and 2) a medical history and clinical presentation consistent with HeFH. The mean baseline LDL-C value was 225 mg/dL (range: 161 to 351 mg/dL) in the Ezetimibe Tablets co-administered with simvastatin group compared to 219 mg/dL (range: 149 to 336 mg/dL) in the simvastatin monotherapy group. The patients received co-administered Ezetimibe Tablets and simvastatin (10 mg, 20 mg, or 40 mg) or simvastatin monotherapy (10 mg, 20 mg, or 40 mg) for 6 weeks, co-administered Ezetimibe Tablets and 40 mg simvastatin or 40 mg simvastatin monotherapy for the next 27 weeks, and open-label co-administered Ezetimibe Tablets and simvastatin (10 mg, 20 mg, or 40 mg) for 20 weeks thereafter.

The results of the study at Week 6 are summarized in Table 3. Results at Week 33 were consistent with those at Week 6. TABLE 3: Mean Percent Difference at Week 6 Between the Pooled Ezetimibe Tablets Co-Administered with Simvastatin Group and the Pooled Simvastatin Monotherapy Group in Adolescent Patients with Heterozygous Familial Hypercholesterolemia Total-C LDL-C Apo B Non-HDL-C TG* HDL-C Mean percent difference between treatment groups -12% -15% -12% -14% -2% +0.1% 95% Confidence Interval (-15%,-9%) (-18%,-12%) (-15%, -9%) (-17%, -11%) (-9%, +4%) (-3%, +3%) * For triglycerides, median % change from baseline From the start of the trial to the end…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Pregnancy Category C: There are no adequate and well-controlled studies of ezetimibe in pregnant women. Ezetimibe should be used during pregnancy only if the potential benefit justifies the risk to the fetus. In oral (gavage) embryo-fetal development studies of ezetimibe conducted in rats and rabbits during organogenesis, there was no evidence of embryolethal effects at the doses tested (250, 500, 1000 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 1000 mg/kg/day (~10 x 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 1000 mg/kg/day (150 x the human exposure at 10 mg daily based on AUC 0-24hr for total ezetimibe). Ezetimibe crossed the placenta when pregnant rats and rabbits were given multiple oral doses.

Multiple-dose studies of ezetimibe given in combination with statins in rats and rabbits during organogenesis result in higher ezetimibe and statin exposures. Reproductive findings occur at lower doses in combination therapy compared to monotherapy. All statins are contraindicated in pregnant and nursing women.

When Ezetimibe Tablet is administered with a statin in a woman of childbearing potential, refer to the pregnancy category and product labeling for the statin. [See Contraindications ( 4 ).]

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The effects of Ezetimibe Tablets co-administered with simvastatin (n=126) compared to simvastatin monotherapy (n=122) have been evaluated in adolescent boys and girls with heterozygous familial hypercholesterolemia (HeFH). In a multicenter, double-blind, controlled study followed by an open-label phase, 142 boys and 106 postmenarchal girls, 10 to 17 years of age (mean age 14.2 years, 43% females, 82% Caucasians, 4% Asian, 2% Blacks, 13% multi-racial) with HeFH were randomized to receive either Ezetimibe Tablets co-administered with simvastatin or simvastatin monotherapy.

Inclusion in the study required 1) a baseline LDL-C level between 160 and 400 mg/dL and 2) a medical history and clinical presentation consistent with HeFH. The mean baseline LDL-C value was 225 mg/dL (range: 161 to 351 mg/dL) in the Ezetimibe Tablets co-administered with simvastatin group compared to 219 mg/dL (range: 149 to 336 mg/dL) in the simvastatin monotherapy group. The patients received co-administered Ezetimibe Tablets and simvastatin (10 mg, 20 mg, or 40 mg) or simvastatin monotherapy (10 mg, 20 mg, or 40 mg) for 6 weeks, co-administered Ezetimibe Tablets and 40 mg simvastatin or 40 mg simvastatin monotherapy for the next 27 weeks, and open-label co-administered Ezetimibe Tablets and simvastatin (10 mg, 20 mg, or 40 mg) for 20 weeks thereafter.

The results of the study at Week 6 are summarized in Table 3. Results at Week 33 were consistent with those at Week 6. TABLE 3: Mean Percent Difference at Week 6 Between the Pooled Ezetimibe Tablets Co-Administered with Simvastatin Group and the Pooled Simvastatin Monotherapy Group in Adolescent Patients with Heterozygous Familial Hypercholesterolemia Total-C LDL-C Apo B Non-HDL-C TG* HDL-C Mean percent difference between treatment groups -12% -15% -12% -14% -2% +0.1% 95% Confidence Interval (-15%,-9%) (-18%,-12%) (-15%, -9%) (-17%, -11%) (-9%, +4%) (-3%, +3%) * For triglycerides, median % change from baseline From the start of the trial to the end of Week 33, discontinuations due to an adverse reaction occurred in 7 (6%) patients in the Ezetimibe Tablets co-administered with simvastatin group and in 2 (2%) patients in the simvastatin monotherapy group.

During the trial, hepatic transaminase elevations (two consecutive measurements for ALT and/or AST ≥3 x ULN) occurred in four (3%) individuals in the Ezetimibe Tablets co-administered with simvastatin group and in two (2%) individuals in the simvastatin monotherapy group. Elevations of CPK (≥10 x ULN) occurred in two (2%) individuals in the Ezetimibe Tablets co-administered with simvastatin group and in zero individuals in the simvastatin monotherapy group. In this limited controlled study, there was no significant effect on growth or sexual maturation in the adolescent boys or girls, or on menstrual cycle length in girls.

Co-administration of Ezetimibe Tablets with simvastatin at doses greater than 40 mg/day has not been studied in adolescents. Also, Ezetimibe Tablets has not been studied in patients younger than 10 years of age or in pre-menarchal girls. Based on total ezetimibe (ezetimibe + ezetimibe-glucuronide), there are no pharmacokinetic differences between adolescents and adults.

Pharmacokinetic data in the pediatric population <10 years of age are not available.

🧓 Geriatric Use 108 words ▾

8.5Geriatric Use Monotherapy Studies Of the 2396 patients who received Ezetimibe Tablets in clinical studies, 669 (28%) were 65 and older, and 111 (5%) were 75 and older. Statin Co-Administration Studies Of the 11,308 patients who received Ezetimibe Tablets + statin in clinical studies, 3587 (32%) were 65 and older, and 924 (8%) were 75 and older. No overall differences in safety and effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out [see Clinical Pharmacology ( 12.3 )] .

🆘 Overdosage 86 words ▾

10 OVERDOSAGE In clinical studies, administration of ezetimibe, 50 mg/day to 15 healthy subjects for up to 14 days, 40 mg/day to 18 patients with primary hyperlipidemia for up to 56 days, and 40 mg/day to 27 patients with homozygous sitosterolemia for 26 weeks was generally well tolerated. One female patient with homozygous sitosterolemia took an accidental overdose of ezetimibe 120 mg/day for 28 days with no reported clinical or laboratory adverse events. In the event of an overdose, symptomatic and supportive measures should be employed.

🧬 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. In a 2-week clinical study in 18 hypercholesterolemic patients, Ezetimibe Tablets inhibited intestinal cholesterol absorption by 54%, compared with placebo. Ezetimibe Tablets had no clinically meaningful effect on the plasma concentrations of the fat-soluble vitamins A, D, and E (in a study of 113 patients), and did not impair adrenocortical steroid hormone production (in a study of 118 patients).

The cholesterol content of the liver is derived predominantly from three sources. The liver can synthesize cholesterol, take up cholesterol from the blood from circulating lipoproteins, or take up cholesterol absorbed by the small intestine. Intestinal cholesterol is derived primarily from cholesterol secreted in the bile and from dietary cholesterol.

Ezetimibe has a mechanism of action that differs from those of other classes of cholesterol-reducing compounds (statins, bile acid sequestrants [resins], fibric acid derivatives, and plant stanols). 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 does not inhibit cholesterol synthesis in the liver, or increase bile acid excretion.

Instead, 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 clearance of cholesterol from the blood; this distinct mechanism is complementary to that of statins and of fenofibrate [see Clinical Studies ( 14.1 )] .

12.2Pharmacodynamics Clinical studies have demonstrated that elevated levels of total-C, LDL-C and Apo B, the major protein constituent of LDL, promote human atherosclerosis. In addition, decreased levels of HDL-C are associated with the development of atherosclerosis. Epidemiologic studies have established that cardiovascular morbidity and mortality vary directly with the level of total-C and LDL-C and inversely with the level of HDL-C.

Like LDL, cholesterol-enriched triglyceride-rich lipoproteins, including very-low-density lipoproteins (VLDL), intermediate-density lipoproteins (IDL), and remnants, can also promote atherosclerosis. The independent effect of raising HDL-C or lowering TG on the risk of coronary and cardiovascular morbidity and mortality has not been determined. Ezetimibe Tablets reduces total-C, LDL-C, Apo B, non-HDL-C, and TG, and increases HDL-C in patients with hyperlipidemia.

Administration of Ezetimibe Tablets with a statin is effective in improving serum total-C, LDL-C, Apo B, non-HDL-C, TG, and HDL-C beyond either treatment alone. Administration of Ezetimibe Tablets with fenofibrate is effective in improving serum total-C, LDL-C, Apo B, and non-HDL-C in patients with mixed hyperlipidemia as compared to either treatment alone. The effects of ezetimibe given either alone or in addition to a statin or fenofibrate on cardiovascular morbidity and mortality have not been established.

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 Tablets to fasted adults, mean ezetimibe peak plasma concentrations (Cmax) of 3.4 to 5.5 ng/mL were attained within 4 to 12 hours (Tmax).Ezetimibe-glucuronide mean Cmax values of 45 to 71 ng/mL were achieved between 1 and 2 hours (Tmax). There was no substantial deviation from dose proportionality between 5 and 20 mg.

The absolute bioavailability of ezetimibecannot be determined, as the compound is virtually insoluble in aqueous media suitable for injection. Effect of Food on Oral Absorption Concomitant food administration (high-fa…

🧬 Mechanism of Action ~1 min read ▾

12.1Mechanism of Action Ezetimibe reduces blood cholesterol by inhibiting the absorption of cholesterol by the small intestine. In a 2-week clinical study in 18 hypercholesterolemic patients, Ezetimibe Tablets inhibited intestinal cholesterol absorption by 54%, compared with placebo. Ezetimibe Tablets had no clinically meaningful effect on the plasma concentrations of the fat-soluble vitamins A, D, and E (in a study of 113 patients), and did not impair adrenocortical steroid hormone production (in a study of 118 patients).

The cholesterol content of the liver is derived predominantly from three sources. The liver can synthesize cholesterol, take up cholesterol from the blood from circulating lipoproteins, or take up cholesterol absorbed by the small intestine. Intestinal cholesterol is derived primarily from cholesterol secreted in the bile and from dietary cholesterol.

Ezetimibe has a mechanism of action that differs from those of other classes of cholesterol-reducing compounds (statins, bile acid sequestrants [resins], fibric acid derivatives, and plant stanols). 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 does not inhibit cholesterol synthesis in the liver, or increase bile acid excretion.

Instead, 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 clearance of cholesterol from the blood; this distinct mechanism is complementary to that of statins and of fenofibrate [see Clinical Studies ( 14.1 )] .

📦 How Supplied / Storage and Handling 75 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Ezetimibe Tablets, USP 10 mg, are white to off white capsule shaped, flat faced, beveled edge tablets, debossed with ‘A25’ on one side and plain on other side. They are supplied as follows: NDC 71205-277-30 bottles of 30 NDC 71205-277-60 bottles of 60 NDC 71205-277-90 bottles of 90 Storage Store at 25°C (77°F); excursions permitted between 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature.] Protect from moisture.

📋 Description 120 words ▾

11 DESCRIPTION Ezetimibe, USP is in a class of lipid-lowering compounds that selectively inhibits the intestinal absorption of cholesterol and related phytosterols. The chemical name of ezetimibe, USP 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, USP is a white to off white, crystalline powder that is soluble in methanol. Ezetimibe, USP has a melting point of about 163°C and is stable at ambient temperature. Ezetimibe Tablet, USP is available as a tablet for oral administration containing 10 mg of ezetimibe, USP and the following inactive ingredients: lactose monohydrate, croscarmellose sodium, Hypromellose, sodium lauryl sulfate, crospovidone, microcrystaline cellulose, and magnesium stearate. ezetimibe-structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION See FDA-Approved Patient Labeling (Patient Information). Patients should be advised to adhere to their National Cholesterol Education Program (NCEP)-recommended diet, a regular exercise program, and periodic testing of a fasting lipid panel.

17.1Muscle Pain All patients starting therapy with ezetimibe should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, tenderness or weakness. The risk of this occurring is increased when taking certain types of medication. Patients should discuss all medication, both prescription and over-the-counter, with their physician.

17.2Liver Enzymes Liver tests should be performed when Ezetimibe Tablet is added to statin therapy and according to statin recommendations.

17.3Pregnancy Women of childbearing age should be advised to use an effective method of birth control to prevent pregnancy while using Ezetimibe Tablets added to statin therapy. Discuss future pregnancy plans with your patients, and discuss when to stop combination Ezetimibe Tablets and statin therapy if they are trying to conceive. Patients should be advised that if they become pregnant they should stop taking combination Ezetimibe Tablets and statin therapy and call their healthcare professional.

17.4Breastfeeding Women who are breastfeeding should be advised to not use Ezetimibe Tablets added to statin therapy. Patients who have a lipid disorder and are breastfeeding should be advised to discuss the options with their healthcare professionals. Manufactured by: Alkem Laboratories Ltd.

Mumbai - 400 013, INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 Revised: March, 2017 PT 2508-01

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
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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) ✓ 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 Proficient Rx LP. 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 2 other package presentations of this same product, including 30 tablets (71205-0277-30), 90 tablets (71205-0277-90). 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?
Proficient Rx LP 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.
← 71205-0276-06 · Proficient 71205-0278-30 · Proficient →
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.