What this pack is
VYTORIN is the brand name in this record; ezetimibe and simvastatin is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
VYTORINGeneric nameezetimibe and simvastatin
How this medicine works
The current label describes ezetimibe as inhibiting NPC1L1-mediated cholesterol absorption at the intestinal brush border and simvastatin as inhibiting HMG-CoA reductase after activation. Two complementary pathways in one tablet do not mean everyone needs the combination or permit self-assembly from another statin and single-ingredient ezetimibe.
Read source: United States ↗Current regulatory record · reviewed 2026-08-29More about its action and precautions →Check the market, names, dosage form and route together
A medicine may use different brand names across markets. Keep the market, brand, generic name, dosage form and route together; one matching field does not prove that two packs are the same or interchangeable.
Open the complete product-identity record
Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.
- International brand name
- VYTORIN
- Generic name
- ezetimibe and simvastatin
- Dosage-form class
- Ezetimibe/simvastatin fixed two-ingredient oral tablets: 10/10, 10/20, 10/40 and 10/80 mg; each pair states the two ingredients in one tablet; the current label separately lists 30- and 90-tablet bottles
- Route
- Oral
- Package-image status
- A source-linked public label image is available below
No source-verifiable mainland-China trade-name cue has been established for this record. This does not establish whether the medicine exists, is approved or is available in mainland China. Check pack text and current CDE/NMPA records item by item.
FOR EVERYDAY QUESTIONS
After the leaflet, continue with the question you still need to check
What this page can show
This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.
What to bring to the next conversation
Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.
NEXT SAFE STEP
Choose the next safe check
A question about changing, combining or splitting?Put the exact packs on one list before a pharmacist or prescriber checks the full context.Open the family medicine list →A question about cost, reimbursement or availability?First lock the market, exact presentation and date. Use local official reimbursement, hospital or pharmacy channels for a current answer rather than a web estimate.Open regulator and market-record entry points →Unsure about a pack or a cross-border product?Photo reading can return possible record matches only. Check the actual product against the current regulator record for its market.Identify pack text locally →Saw a recall, approval or procurement headline?Open the original publisher, then match its product, market and date. Do not make a stop or switch decision from a headline.Read primary-source news →
PRODUCT PRESENTATION IDENTITY
Strength, pack and device identity
Package strength is not an individual dose. These fields help identify the exact labelled product; they do not calculate how much, how often, a missed-use action, splitting, switching or conversion.
How to read a score line: ‘scored’ or ‘unscored’ first identifies this labelled presentation. A score line by itself does not permit self-splitting, reducing or changing the product. Only an explicit statement in the current label for this exact presentation, checked with a pharmacist against the prescription, can support any further handling.
8 source-backed strength, pack or device records — open the full list
First match the market, dosage form and labelled amount on the pack in hand. The number of tablets, sachets or devices in a pack is not a personal dose or schedule.
United States label · Current U.S. DailyMed public label (updated 21 Jan 2026; label revised Mar 2024; verified 29 Aug 2026)
Ezetimibe 10 mg plus simvastatin 10 mg per tablet; 30-tablet bottle
- Product code
- NDC 78206-174-01
- Form and route
- VYTORIN ezetimibe/simvastatin oral tablet · oral (fixed two-ingredient product-identity field)
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- ezetimibe
- 10 mglabelled amount of the first ingredient per tablet; not an instruction to add ZETIA, switch products or choose a tablet count
- simvastatin
- 10 mglabelled amount of the second ingredient per tablet; not an instruction to add ZOCOR, another statin or convert by milligrams
- Package
- 30 tablets per bottle
- Labelled appearance
- white to off-white · capsule-shaped, unscored tablet, approximately 8 mm; an unscored tablet does not establish permission to split or crush it · imprint 311Unscored in this labelled presentation
United States label · Current U.S. DailyMed public label (updated 21 Jan 2026; label revised Mar 2024; verified 29 Aug 2026)
Ezetimibe 10 mg plus simvastatin 10 mg per tablet; 90-tablet bottle
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 78206-174-02
- Form and route
- VYTORIN ezetimibe/simvastatin oral tablet · oral (fixed two-ingredient product-identity field)
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- ezetimibe
- 10 mglabelled amount of the first ingredient per tablet; not an instruction to add ZETIA, switch products or choose a tablet count
- simvastatin
- 10 mglabelled amount of the second ingredient per tablet; not an instruction to add ZOCOR, another statin or convert by milligrams
- Package
- 90 tablets per bottle
- Labelled appearance
- white to off-white · capsule-shaped, unscored tablet, approximately 8 mm; an unscored tablet does not establish permission to split or crush it · imprint 311Unscored in this labelled presentation
United States label · Current U.S. DailyMed public label (updated 21 Jan 2026; label revised Mar 2024; verified 29 Aug 2026)
Ezetimibe 10 mg plus simvastatin 20 mg per tablet; 30-tablet bottle
- Product code
- NDC 78206-175-01
- Form and route
- VYTORIN ezetimibe/simvastatin oral tablet · oral (fixed two-ingredient product-identity field)
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- ezetimibe
- 10 mglabelled amount of the first ingredient per tablet; not an instruction to add ZETIA, switch products or choose a tablet count
- simvastatin
- 20 mglabelled amount of the second ingredient per tablet; not an instruction to add ZOCOR, another statin or convert by milligrams
- Package
- 30 tablets per bottle
- Labelled appearance
- white to off-white · capsule-shaped, unscored tablet, approximately 11 mm; an unscored tablet does not establish permission to split or crush it · imprint 312Unscored in this labelled presentation
United States label · Current U.S. DailyMed public label (updated 21 Jan 2026; label revised Mar 2024; verified 29 Aug 2026)
Ezetimibe 10 mg plus simvastatin 20 mg per tablet; 90-tablet bottle
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 78206-175-02
- Form and route
- VYTORIN ezetimibe/simvastatin oral tablet · oral (fixed two-ingredient product-identity field)
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- ezetimibe
- 10 mglabelled amount of the first ingredient per tablet; not an instruction to add ZETIA, switch products or choose a tablet count
- simvastatin
- 20 mglabelled amount of the second ingredient per tablet; not an instruction to add ZOCOR, another statin or convert by milligrams
- Package
- 90 tablets per bottle
- Labelled appearance
- white to off-white · capsule-shaped, unscored tablet, approximately 11 mm; an unscored tablet does not establish permission to split or crush it · imprint 312Unscored in this labelled presentation
United States label · Current U.S. DailyMed public label (updated 21 Jan 2026; label revised Mar 2024; verified 29 Aug 2026)
Ezetimibe 10 mg plus simvastatin 40 mg per tablet; 30-tablet bottle
- Product code
- NDC 78206-176-01
- Form and route
- VYTORIN ezetimibe/simvastatin oral tablet · oral (fixed two-ingredient product-identity field)
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- ezetimibe
- 10 mglabelled amount of the first ingredient per tablet; not an instruction to add ZETIA, switch products or choose a tablet count
- simvastatin
- 40 mglabelled amount of the second ingredient per tablet; not an instruction to add ZOCOR, another statin or convert by milligrams
- Package
- 30 tablets per bottle
- Labelled appearance
- white to off-white · capsule-shaped, unscored tablet, approximately 14 mm; an unscored tablet does not establish permission to split or crush it · imprint 313Unscored in this labelled presentation
United States label · Current U.S. DailyMed public label (updated 21 Jan 2026; label revised Mar 2024; verified 29 Aug 2026)
Ezetimibe 10 mg plus simvastatin 40 mg per tablet; 90-tablet bottle
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 78206-176-02
- Form and route
- VYTORIN ezetimibe/simvastatin oral tablet · oral (fixed two-ingredient product-identity field)
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- ezetimibe
- 10 mglabelled amount of the first ingredient per tablet; not an instruction to add ZETIA, switch products or choose a tablet count
- simvastatin
- 40 mglabelled amount of the second ingredient per tablet; not an instruction to add ZOCOR, another statin or convert by milligrams
- Package
- 90 tablets per bottle
- Labelled appearance
- white to off-white · capsule-shaped, unscored tablet, approximately 14 mm; an unscored tablet does not establish permission to split or crush it · imprint 313Unscored in this labelled presentation
United States label · Current U.S. DailyMed public label (updated 21 Jan 2026; label revised Mar 2024; verified 29 Aug 2026)
Ezetimibe 10 mg plus simvastatin 80 mg per tablet; 30-tablet bottle
- Product code
- NDC 78206-177-01
- Form and route
- VYTORIN ezetimibe/simvastatin oral tablet · oral (fixed two-ingredient product-identity field)
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- ezetimibe
- 10 mglabelled amount of the first ingredient per tablet; not an instruction to add ZETIA, switch products or choose a tablet count
- simvastatin
- 80 mglabelled amount of the second ingredient per tablet; not an instruction to add ZOCOR, another statin or convert by milligrams
- Package
- 30 tablets per bottle
- Labelled appearance
- white to off-white · capsule-shaped, unscored tablet, approximately 17 mm; an unscored tablet does not establish permission to split or crush it · imprint 315Unscored in this labelled presentation
United States label · Current U.S. DailyMed public label (updated 21 Jan 2026; label revised Mar 2024; verified 29 Aug 2026)
Ezetimibe 10 mg plus simvastatin 80 mg per tablet; 90-tablet bottle
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 78206-177-02
- Form and route
- VYTORIN ezetimibe/simvastatin oral tablet · oral (fixed two-ingredient product-identity field)
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- ezetimibe
- 10 mglabelled amount of the first ingredient per tablet; not an instruction to add ZETIA, switch products or choose a tablet count
- simvastatin
- 80 mglabelled amount of the second ingredient per tablet; not an instruction to add ZOCOR, another statin or convert by milligrams
- Package
- 90 tablets per bottle
- Labelled appearance
- white to off-white · capsule-shaped, unscored tablet, approximately 17 mm; an unscored tablet does not establish permission to split or crush it · imprint 315Unscored in this labelled presentation
PUBLIC LABEL IMAGE
Appearance and package-text clues
This current public-label package panel helps check the brand, generic name, strength and dosage-form clues only. It does not authenticate a product in hand or establish originator status, availability, sale eligibility, another package or another market.
Open the public label source ↗PARTIAL PACKAGE-VISUAL COVERAGE
Some pack presentations have text-only identity records
The current label provides exact official display images only for the four 30-tablet bottles. The four 90-tablet bottles have distinct NDCs and label text but no matching display images, so the site explicitly presents them as text-only identity cards.
LABEL READING · NOT A PRESCRIPTION
VYTORIN label reading: one tablet already contains ezetimibe and simvastatin; first check for duplicate lipid-lowering ingredients
Reading level: drug-specific label reading. This record has been expanded around its dosage form or a higher-risk reading question; the current target-market label and professional review still apply.
The paired numbers identify two ingredients in one VYTORIN tablet. For example, 10/40 mg means ezetimibe 10 mg plus simvastatin 40 mg; it is not two tablets, half a tablet or a conversion formula for adding single-ingredient products. The label requires review of the full medicine list, age, kidney and liver function, thyroid status and interactions; the site does not choose an individual strength.
- Check active ingredients on every pack. ZETIA is ezetimibe alone and ZOCOR is simvastatin alone; LIPITOR, CRESTOR, LIVALO and CADUET contain other statins. Suspected duplication may be accidental or intentionally prescribed. Do not combine, alternate by day or stop a pack yourself.
- Age 65 years or older, uncontrolled hypothyroidism, renal impairment, certain interacting medicines and higher strengths increase the labelled risk of myopathy and rhabdomyolysis; the current label also says Chinese patients may be at higher risk. Promptly contact the care team for unexplained muscle pain, tenderness or weakness, especially with fever, malaise or dark urine; use local emergency services for severe or rapidly worsening symptoms, altered consciousness or markedly reduced urine.
- The current label and Orange Book still record 10/80 mg, but the label restricts it to defined chronic-tolerance circumstances and states that higher strengths carry greater myopathy risk. The site does not interpret RS status or pack existence as permission to start, increase to or continue this strength.
- The current label identifies important interaction boundaries involving strong CYP3A4 inhibitors, cyclosporine, danazol, gemfibrozil, amiodarone, diltiazem, amlodipine, colchicine and grapefruit juice. Do not use the site to stop a medicine, schedule separation or change a strength; have a pharmacist review the exact products, foods or drinks, supplements and complete medicine list.
- Acute liver failure or decompensated cirrhosis is a labelled contraindication boundary. Marked fatigue, loss of appetite, right-upper-abdominal discomfort, dark urine or jaundice needs timely medical assessment; the site does not read laboratory values to decide continuation, interruption or adjustment.
- Pregnancy may cause fetal harm and breastfeeding is not recommended during treatment. Anyone who is pregnant, may be pregnant, plans pregnancy or is breastfeeding should contact the prescribing team promptly and should not arrange stopping or switching independently.
- All four tablets are white to off-white, capsule-shaped and unscored, with imprints 311, 312, 313 and 315. Imprints only help distinguish strengths within this label and cannot authenticate a product alone; unscored tablets do not establish permission to split or crush them.
PHARMACOVIGILANCE · OFFICIAL ROUTES
Check safety information in the right market
Start with the public label or product record linked to this dossier, then use the official safety routes below for the market that applies to the medicine in hand.
Match five details before using a safety record
- Brand and generic nameBoth must match the medicine named by the record.
- Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
- Market and notice dateA record applies only to the country or region and date it names.
- Lot, pack and manufacturerRecord these only when the official notice specifically names them.
- Current product informationA historical record may have been superseded by the current label.
This checklist only helps organise the right question. It does not create a personal conclusion about stopping, switching, dose, combination or suitability.
This dossier’s product-level source checkU.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-08-29
This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk.
Markets actually represented by the reviewed product documents
- United States · 3
This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.
This record’s label or product-record routeDailyMed (NLM): current U.S. VYTORIN ezetimibe/simvastatin public label (updated 21 Jan 2026; label text revised Mar 2024) ↗Current regulatory record · reviewed 2026-08-29
Other official market or version documents for this record
These are separately reviewed product documents for the same dossier. Their market, date, dosage form and document status must stay attached to each link; they do not establish interchangeability between products, strengths, packs, indications or countries.
- FDA · United States · Regulatory product record or label archive · 2026-08-29Current FDA Orange Book data: VYTORIN, NDA 021687; four oral-tablet strengths listed as prescription RLD products, with 10/80 mg also listed as the RS ↗reviewed 2026-08-29
- FDA · United States · Regulatory product record or label archive · 2026-08-29FDA Drugs@FDA official search entry: VYTORIN NDA 021687 application and label records ↗reviewed 2026-08-29
This is not a conclusion that the medicine has no risk, warning, recall or newer notice in another market. Start with the checked product-level label above, then use the official market gateways below for the product in hand.
See the reviewed safety-record directory →Global official safety gateways
- NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
- FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
- FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
- EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
- MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
- PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
- MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
- HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
- Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
- TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
- Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
- Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
- SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
- WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
- Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22
This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.
For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.
PRIVATE FAMILY LIST
Bring this record into a local medicine list
Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.
Add to the family medicine list →PACK · LABEL · MEDICINE LIST
Six checks for this medicine pack
Use this card to organise questions about VYTORIN (ezetimibe and simvastatin). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
VYTORIN is the brand in this record and ezetimibe and simvastatin is the active-ingredient name. Check both with the dosage form (Ezetimibe/simvastatin fixed two-ingredient oral tablets: 10/10, 10/20, 10/40 and 10/80 mg; each pair states the two ingredients in one tablet; the current label separately lists 30- and 90-tablet bottles) and the market on the actual pack.
Read the labelled strength in context
mg, mcg, mg/mL or a percentage describes the labelled amount in one tablet, capsule, measured volume, spray or other unit. It is not an answer to how many units a person should take.
Check before splitting or opening
Before splitting, crushing, chewing or opening anything, find an explicit instruction for this exact product in its current label and ask a pharmacist. A score line or a previous pack is not enough by itself.
Put every product on one list
Include prescriptions, over-the-counter products, eye drops, creams, vitamins, minerals, herbs and supplements. A pharmacist or prescriber needs the whole list before any combination, alternation, switch or stop is considered.
Ask a specific pharmacogenetics question
Ask which medicine, which gene and what clinical decision a result could change. A gene–drug association does not mean broad genetic testing is needed for everyone and must not be used to change treatment without professional review.
Know when to seek urgent help
For a suspected overdose, a severe allergic reaction, fainting or difficulty breathing, use the local emergency or poison-information service now. Do not wait for a website reply or alter several medicines to test what caused it.
This card does not calculate a dose, decide whether medicines can be combined, or replace a clinician or pharmacist. Market-specific current labels and the person's full context still need review.
MARKET DOCUMENTS · READ SEPARATELY
Enlarged market leaflets and regulator documents
Each link retains its own market, date, dosage form and document status. These documents support larger-print reading and item-by-item checking; they do not make products, strengths, packs, indications or use between countries or regions interchangeable.
- DailyMed (NLM): current U.S. VYTORIN ezetimibe/simvastatin public label (updated 21 Jan 2026; label text revised Mar 2024) ↗Current regulatory record · reviewed 2026-08-29
- Current FDA Orange Book data: VYTORIN, NDA 021687; four oral-tablet strengths listed as prescription RLD products, with 10/80 mg also listed as the RS ↗reviewed 2026-08-29
- FDA Drugs@FDA official search entry: VYTORIN NDA 021687 application and label records ↗reviewed 2026-08-29
HOW IT WORKS · NOT A TREATMENT PLAN
How the two ingredients differ: ezetimibe reduces intestinal cholesterol absorption while simvastatin acts on the hepatic cholesterol-synthesis pathway
- Ezetimibe acts on cholesterol absorption and simvastatin on cholesterol synthesis. Different targets do not cancel adverse effects or permit self-adding the medicine to another statin.
- The ezetimibe component is 10 mg per tablet in all four strengths; the simvastatin component changes. Neither number nor their total establishes equivalence, and they cannot be converted by milligrams to CADUET, LIPITOR, CRESTOR or ZOCOR.
- Genetic results may help professionals interpret statin exposure or myopathy risk in defined clinical settings, but the site does not recommend broad genetic screening from a brand name or replace the full medicine list, symptoms, kidney and liver function and clinical assessment with one genetic result.
SOURCE EVIDENCE REGISTER
Source evidence map
Every public link is labelled with its market, document status and document type. A historical public record is not a current label, and an official lookup entry is not a product-specific record.
- DailyMed (NLM): current U.S. VYTORIN ezetimibe/simvastatin public label (updated 21 Jan 2026; label text revised Mar 2024) ↗Current regulatory record · reviewed 2026-08-29
- Current FDA Orange Book data: VYTORIN, NDA 021687; four oral-tablet strengths listed as prescription RLD products, with 10/80 mg also listed as the RS ↗reviewed 2026-08-29
- FDA Drugs@FDA official search entry: VYTORIN NDA 021687 application and label records ↗reviewed 2026-08-29
- FDA: VYTORIN NDA 021687 original medical review (2004) ↗reviewed 2026-08-29
SOURCE-TRACEABLE ARCHIVE
VYTORINezetimibe and simvastatin
This page includes an exact current U.S. public-label package panel for VYTORIN, alongside documentary primary-source material. It helps check product identity, but does not itself establish originator status, product quality, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
Four fixed VYTORIN strengths approved
Current FDA Orange Book data list 23 Jul 2004 as the approval date for 10/10, 10/20, 10/40 and 10/80 mg; the original medical review describes the development and review basis for the four fixed combinations.
FDA: VYTORIN NDA 021687 original medical review (2004) ↗Current DailyMed page updated
The page lists four strengths, eight bottle NDCs, four official 30-tablet display panels, tablet appearances and enlarged safety information; the label revision date remains Mar 2024.
DailyMed (NLM): current U.S. VYTORIN ezetimibe/simvastatin public label (updated 21 Jan 2026; label text revised Mar 2024) ↗Orange Book identity reviewed
Current data list four prescription RLD strengths and identify 10/80 mg as the RS.
Current FDA Orange Book data: VYTORIN, NDA 021687; four oral-tablet strengths listed as prescription RLD products, with 10/80 mg also listed as the RS ↗
MARKET SCOPE
Market-record boundary
United States
All four Orange Book strengths are prescription RLD products; 10/80 mg is also RS; current DailyMed label lists eight bottle NDCsFour 30-tablet bottles have official display images; four 90-tablet bottles have label-text identity only. No record establishes real-time pharmacy stock, purchasing eligibility, individual suitability or interchangeability.
Mainland China and other markets
Current market record not establishedNo local approval, trade name, pack, supply or interchangeability is inferred from the U.S. brand, shared ingredients or paired numbers.
How to read this record
Read each document in its stated market, date and dosage-form context. A historical record is not a current label and does not support individual medical, substitution or purchasing conclusions.
Keep international and mainland China records separate
This page has a U.S. public history/regulatory archive but no mainland China record for this specific product. That does not establish whether the medicine exists, is approved or is available in mainland China. Verify product identity, dosage form, strength, holder and the current label item by item.
RECORD FAQ
Record questions
Is VYTORIN the same as ZETIA plus ZOCOR?
One VYTORIN tablet contains ezetimibe and simvastatin, corresponding to the ingredients in those two single-ingredient brands, but exact strengths, labels, prescriptions and individual plans must be reviewed. Do not replace two single-ingredient packs with VYTORIN or add them to VYTORIN yourself.
Why does one strength have 30- and 90-tablet NDCs but only one image?
The current label lists separate NDCs for both packs, but the official display panel corresponds only to the 30-tablet bottle. The site therefore keeps the 90-tablet bottle as a text-only identity card rather than reusing a misleading 30-tablet image.
Can VYTORIN be taken with another statin?
The site cannot answer an individual's combination question from medicine names alone. VYTORIN already contains simvastatin; another statin, single-ingredient ezetimibe and many interacting medicines require review of the exact packs, prescriptions, forms, strengths, symptoms and full medicine list by a pharmacist or prescribing team. Do not combine, rotate, stop or switch them yourself.
READ NEXT
Related reading
Evidence status
The listed links are public sources selected for traceability. They must be rechecked against the current target-market record before any use beyond reading and research.