What this pack is
PLAQUENIL is the brand name in this record; hydroxychloroquine sulfate is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
PLAQUENILGeneric namehydroxychloroquine sulfate
How this medicine works
The U.S. PLAQUENIL label describes hydroxychloroquine as a 4-aminoquinoline antimalarial and antirheumatic drug, and states that its anti-inflammatory/immunomodulatory mechanism in rheumatoid arthritis, systemic lupus erythematosus and chronic discoid lupus erythematosus is not fully understood. Mechanism reading helps interpret label boundaries; it does not decide anyone's diagnosis, response, tablet count or co-use result.
Read source: United States ↗Current regulatory record · reviewed 2026-08-20More 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
- PLAQUENIL
- Generic name
- hydroxychloroquine sulfate
- Dosage-form class
- Film-coated oral tablets: hydroxychloroquine sulfate 200 mg per tablet (equivalent to 155 mg hydroxychloroquine); this dossier displays exact 100-tablet bottle NDC 59212-562-10
- 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.
1 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 · DailyMed SPL v15, published 21 May 2026
Hydroxychloroquine sulfate 200 mg per tablet (equivalent to 155 mg hydroxychloroquine); 100-tablet bottle
- Product code
- NDC 59212-562-10
- Form and route
- hydroxychloroquine sulfate film-coated oral tablet · oral
- Container
- bottle
- Units in each inner container
- 100 tablets per bottlePackage identity only; not an individual amount to take
- hydroxychloroquine sulfate
- 200 mglabelled amount per tablet; not an individual's tablet count or use plan
- hydroxychloroquine
- 155 mglabelled hydroxychloroquine-equivalent amount per tablet; not a conversion or adjustment instruction
- Package
- 100 tablets per bottle
- Labelled appearance
- white to off-white · film-coated tablet · imprint PLAQUENILUnscored in this labelled presentation
PUBLIC LABEL IMAGE
Appearance and package-text clues
This dated or historical public-label image is for checking the brand, generic-name, strength and dosage-form clues only. It does not authenticate a product or establish originator status, a current label, current packaging, target-market approval or sale eligibility.
Open the public label source ↗LABEL READING · NOT A PRESCRIPTION
PLAQUENIL label reading: check 200 mg per tablet, the exact bottle and the complete medicine list first
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.
This module uses the current U.S. DailyMed public label to check PLAQUENIL, hydroxychloroquine sulfate, film-coated oral tablets, labelled amount per tablet, the exact bottle and target market. It provides no individual tablet count, course, missed-use remedy, combination, stopping or switching plan.
- “200 mg” is the labelled amount in each tablet of this exact product, not a webpage instruction for how many tablets any person should take per day. The same name, a different market, another pack or another dosage form cannot be self-converted from one number.
- The current label states that these tablets should not be crushed or divided. Do not treat “half a tablet” as a way to halve, make up, adjust or interchange medicine; if the actual pack, swallowing situation or prescription differs from this page, take the pack to a pharmacist or prescribing team.
- The current label notes that retinal toxicity is related to cumulative dosage and treatment duration and lists baseline and during-treatment eye examinations. A webpage cannot decide an individual's eye symptoms, need for testing or timing of adjustment; contact the local care team promptly for visual changes or another concern.
- The label also notes cardiomyopathy, arrhythmias and risks involving multiple co-medications. Do not self-add, stop, switch or separate any glucose-lowering medicine, antiseizure medicine, immune-related medicine, anti-infective, stomach medicine, herb or supplement from a webpage; have a clinician or pharmacist review the complete prescription, OTC and supplement list item by item.
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 · 2026-08-20
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 · 1
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. PLAQUENIL hydroxychloroquine sulfate public label (Advanz Pharma US Corp.; SPL v15, published 21 May 2026) ↗Current regulatory record · reviewed 2026-08-20
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 PLAQUENIL (hydroxychloroquine sulfate). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
PLAQUENIL is the brand in this record and hydroxychloroquine sulfate is the active-ingredient name. Check both with the dosage form (Film-coated oral tablets: hydroxychloroquine sulfate 200 mg per tablet (equivalent to 155 mg hydroxychloroquine); this dossier displays exact 100-tablet bottle NDC 59212-562-10) 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.
HOW IT WORKS · NOT A TREATMENT PLAN
How PLAQUENIL works: the label describes anti-inflammatory and immunomodulatory pathways that remain incompletely understood
- “Not fully understood” is not space for a guess after missing information; it is a reminder that one mechanism term cannot predict that an individual will respond, will not respond or should self-change a treatment plan.
- “Anti-inflammatory”, “immunomodulatory” or “antimalarial” are labelled class/action clues, not grounds to treat different diseases, dosage forms, brands or products sharing a generic name as automatically interchangeable, combinable or usable at the same tablet count.
- For an older person or family member using multiple medicines, the useful next step is not to reason out interactions from a mechanism. List every pack, OTC product and supplement so a pharmacist or clinician can review them against the exact diagnosis, tests and current labels.
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. PLAQUENIL hydroxychloroquine sulfate public label (Advanz Pharma US Corp.; SPL v15, published 21 May 2026) ↗Current regulatory record · reviewed 2026-08-20
SOURCE-TRACEABLE ARCHIVE
PLAQUENILhydroxychloroquine sulfate
This page links to public primary-source material for PLAQUENIL. The archive is historical or documentary evidence only; it does not by itself establish originator status, product quality, current labelling, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
Initial U.S. approval year listed in the current label
The current PLAQUENIL label lists Initial U.S. Approval: 1955. This year locates this U.S. archive only; it does not establish approval, supply, sale eligibility, originator/generic relationship or individual suitability in Mainland China, the EU, Japan or another market.
DailyMed (NLM): current U.S. PLAQUENIL hydroxychloroquine sulfate public label (Advanz Pharma US Corp.; SPL v15, published 21 May 2026) ↗Current public SPL v15 published on DailyMed
DailyMed lists 21 May 2026 as the publication date for PLAQUENIL film-coated oral-tablet SPL v15. This page selects only one exact 200 mg, NDC 59212-562-10, 100-tablet bottle panel and does not establish another NDC, pack, market, stock, course, individual tablet count, co-use or substitution relationship.
DailyMed (NLM): current U.S. PLAQUENIL hydroxychloroquine sulfate public label (Advanz Pharma US Corp.; SPL v15, published 21 May 2026) ↗
MARKET SCOPE
Market-record boundary
United States
Current film-coated-tablet label and one exact bottle panel linkedThe displayed panel only corresponds to hydroxychloroquine sulfate 200 mg per tablet (equivalent to 155 mg hydroxychloroquine), NDC 59212-562-10, 100-tablet bottle. It does not establish actual availability, stock, individual tablet count, treatment duration, testing schedule, co-use, stopping, switching or another-pack status.
Mainland China, EU, Japan and other markets
Market record not establishedNo local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label or brand name; every market version needs separate checking against current local regulatory information.
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
Does PLAQUENIL 200 mg mean one tablet a day, or that half a tablet can be used to reduce a dose?
No. 200 mg is the labelled amount in each tablet of this exact product; the current label states that it should not be crushed or divided. This page does not turn a labelled amount into an individual tablet count, reduction, make-up use, course, switch or adjustment rule. Take the actual bottle, prescription and complete medicine list to a pharmacist or prescribing team.
Why does the page say that eyes, the heart and all co-medications need joint review?
It is a reading entry point for the current label's retinal-toxicity, cardiomyopathy/arrhythmia and interaction warnings, not a substitute for an individual risk assessment. Contact local medical care promptly for visual changes, palpitations, fainting or another acute serious concern; every medicine, OTC product and supplement should be reviewed item by item by someone who knows the exact prescription.
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.