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ezetimibe 10 mg Tablet, 500-count — NDC 70771-1109-05 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, 500-count — NDC 70771-1109-5 (Billing 70771-1109-05)

by Zydus Lifesciences Limited · 500 TABLET in 1 BOTTLE

This is a package of 500 tablets of ezetimibe 10 mg Tablet from Zydus Lifesciences Limited, marketed since Aug 2017 and currently FDA-listed.

NDC 70771-1109-05
🏷️ FDA NDC (as labeled) 70771-1109-5 billing pads the package segment with a zero
This package
Contains500-count Pack sizes6 compare ↓
Also priced by: Part D plans $0.2167/unit — full pricing hub ↓
Product page 70771-1109-00 Also comes in: 30 tablets 70771-1109-3 90 tablets 70771-1109-9 100 tablets 70771-1109-1 100 tablets 70771-1109-4 1000 tablets 70771-1109-0
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) 70771-1109-5
Product NDC 70771-1109
11-digit billing NDC 70771110905
RxCUI 349556
UNII EOR26LQQ24
Application # ANDA204331
SPL Set ID de814dcd-4759-4e9c-a650-335fb885a79d
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 2017-08-09
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 70771-1109-5 — a 5-4-1 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 package segment → 70771-1109-05. 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 $108.35 / 500 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
70771-1109-00 70771-1109-0 Main listing 1000 TABLET in 1 BOTTLE 2017-08-09 — Active
70771-1109-01 70771-1109-1 100 TABLET in 1 BOTTLE 2017-08-09 — Active
70771-1109-03 70771-1109-3 30 TABLET in 1 BOTTLE 2017-08-09 — Active
70771-1109-04 70771-1109-4 10 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK 2017-08-09 — Active
70771-1109-05 You're viewing this 500 TABLET in 1 BOTTLE 2017-08-09 — Active
70771-1109-09 70771-1109-9 90 TABLET in 1 BOTTLE 2017-08-09 — Active

Pack size FAQ

What quantity is in this package?
This is a 500-count package — 500 tablet in 1 bottle.
How does this package differ from NDC 70771-1109-03?
Both are ezetimibe 10 mg Tablet — the drug itself is identical. This page's package is the 500-count one, while NDC 70771-1109-03 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 mgthis 70771-1109-05 Zydus 500 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 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
Aug 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
ShapeCapsule
Imprint773
Size9 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 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 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • 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 FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • 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.
  • UNII 7CV7WJK4UI
    Sodium stearyl fumarate is a synthetic compound made from stearyl alcohol and fumaric acid. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

8 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

LabelerZydus Lifesciences Limited
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA204331 (ANDA)
Labeler code70771
First marketedAug 2017
Product typeHuman Prescription Drug
Portfolio717 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.
📄 FDA label
📄 FDA label 9 words ▾

No readable label sections were found for this product.

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) ✓ 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 Zydus Lifesciences Limited. 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 5 other package presentations of this same product, including 30 tablets (70771-1109-03), 90 tablets (70771-1109-09), 100 tablets (70771-1109-01). 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?
Zydus Lifesciences Limited 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.
← 70771-1108-03 · Zydus 70771-1110-04 · Zydus →
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.