Hydroxychloroquine
Hydroxychloroquine is an antimalarial and antirheumatic medicine used to treat and prevent malaria and to treat rheumatoid arthritis, systemic lupus erythematosus and chronic discoid lupus erythematosus.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 54 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
How we combine label and product data →
Hydroxychloroquine is an antimalarial that also calms an overactive immune system, used mostly for lupus, where it is a cornerstone, and rheumatoid arthritis, as well as to treat and prevent malaria; it has been on the market for decades and is available as a generic. Most people tolerate it well; taking it with food or milk eases the nausea or stomach upset some notice. The one thing to look for is vision change, since it can permanently damage the retina (the eye’s light-sensing layer), so keep up with your eye exams. It can also disturb heart rhythm, so report fainting or a racing heartbeat, and any mood changes, quickly.
Clinical pearls
- It works slowly for lupus and arthritis, often over several months, so do not quit early for lack of results.
- Get a baseline eye exam in year one; yearly checks usually start after five years, sooner with tamoxifen or kidney disease.
- If you use insulin or other diabetes medicines, check sugar more often, since it can cause severe low blood sugar.
- Mention it whenever a new medicine is prescribed, since pairing it with other QT-prolonging (heart rhythm) drugs is not recommended.
Patient information guide — a plain-language walkthrough of Hydroxychloroquine, written from its FDA label.
What Hydroxychloroquine is used for
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Hydroxychloroquine tablets have several approved uses.
- Treatment of uncomplicated malaria in adults and children
- Prevention of malaria in areas where chloroquine resistance is not reported, in adults and children
- Rheumatoid arthritis in adults
- Systemic lupus erythematosus in adults
- Chronic discoid lupus erythematosus in adults
It is not recommended for complicated malaria, resistant malaria strains, or preventing relapses of P. vivax or P. ovale malaria.
How Hydroxychloroquine works
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Hydroxychloroquine is a 4-aminoquinoline antimalarial. In malaria, it may concentrate in the parasite and block how it processes heme. It is active against the blood forms of sensitive malaria parasites, but not the liver forms of P. vivax and P. ovale.
How it works in arthritis and lupus is not fully known. Malaria resistance to chloroquine is widespread, and parasites resistant to chloroquine also respond less to hydroxychloroquine.
Hydroxychloroquine dosage
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Hydroxychloroquine tablets are taken by mouth with food or milk.
- For arthritis and lupus, tablets are generally taken daily, once or split into two doses.
- For malaria prevention, tablets are taken once weekly on the same day. Start 2 weeks before travel and continue for 4 weeks after leaving.
- Do not crush the tablets. Plaquenil and generic hydroxychloroquine should not be divided. Sovuna has a scored tablet.
Follow your prescriber's directions for dosing and missed doses.
Dosing details from the FDA-approved label
From the Hydroxychloroquine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Malaria prophylaxis in adults
- 400 mg once a week, starting 2 weeks prior to travel to the endemic area, on the same day every week, continuing while in the endemic area and for 4 weeks after leaving the endemic area
- Administer orally with food or milk; do not crush or divide the tablets
- Malaria prophylaxis in pediatric patients ≥ 31 kg
- 6.5 mg/kg actual body weight once a week, starting 2 weeks prior to travel to the endemic area, continuing while in the endemic area and for 4 weeks after leaving the endemic area
- Maximum: up to 400 mg
- Not recommended in pediatric patients less than 31 kg because the lowest available strength (200 mg) exceeds the recommended dose and cannot be divided
- Treatment of uncomplicated malaria in adults
- 800 mg initially
- Subsequently 400 mg at 6 hours, 24 hours, and 48 hours after the initial dose (total dosage = 2,000 mg)
- For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary
- Treatment of uncomplicated malaria in pediatric patients ≥ 31 kg
- 13 mg/kg initially
- Subsequently 6.5 mg/kg at 6 hours, 24 hours, and 48 hours after the initial dose (total dosage = 31 mg/kg)
- Maximum: up to 800 mg initially, up to 400 mg per subsequent dose; total up to 2,000 mg
- For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary
- Rheumatoid arthritis in adults, initial dosage
- 400 mg to 600 mg daily as a single daily dose or two divided doses
- Daily doses exceeding 5 mg/kg (actual weight) increase the incidence of retinopathy; may require weeks to months for maximum effect
- Rheumatoid arthritis in adults, chronic dosage
- 200 mg once daily to 400 mg daily, as a single dose or two divided doses
- Daily doses exceeding 5 mg/kg (actual weight) increase the incidence of retinopathy
- Systemic lupus erythematosus in adults
- 200 mg given once daily, or 400 mg given once daily or in two divided doses
- Chronic discoid lupus erythematosus in adults
- 200 mg given once daily, or 400 mg given once daily or in two divided doses
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Malaria in Adult and Pediatric Patients (2.2): • Prophylaxis: Begin weekly doses 2 weeks prior to travel to the endemic area, continue weekly doses while in the endemic area, and continue the weekly doses for 4 weeks after leaving the endemic area: o Adults: 400 mg once a week o Pediatric patients ≥ 31 kg: 6.5 mg/kg up to 400 mg, once a week • Treatment of Uncomplicated Malaria: See Full Prescribing Information (FPI) for complete dosing information. Rheumatoid Arthritis in Adults (2.3): • Initial dosage: 400 mg to 600 mg daily • Chronic dosage: 200 mg once daily or 400 mg once daily (or in two divided doses) Systemic Lupus Erythematosus in Adults (2.4): • 200 mg once daily or 400 mg once daily (or in two divided doses) Chronic Discoid Lupus Erythematosus in Adults (2.5): • 200 mg once daily or 400 mg once daily (or in two divided doses) 2.1 Important Administration Instructions Administer hydroxychloroquine sulfate tablets orally with food or milk. Do not crush or divide the tablets. 2.2 Dosage for Malaria in Adult and Pediatric Patients Hydroxychloroquine sulfate tablets are not recommended in pediatric patients less than 31 kg because the lowest available strength (200 mg) exceeds the recommended dose for these patients and it cannot be divided. Prophylaxis Treatment must start 2 weeks before travel to an endemic area. Advise the patient to take the prophylaxis dosage once a week, staring 2 weeks prior to travel to the endemic area, on the same day every week, continuing the same weekly dose while in the endemic area, and for 4 weeks after leaving the endemic area. The recommended prophylaxis dosage is: • Adult patients: 400 mg once a week • Pediatric patients ≥ 31kg: 6.5 mg/kg actual body weight (up to 400 mg) once a week Treatment of Uncomplicated Malaria The dosages for the treatment of uncomplicated malaria are: • Adult patients: Administer 800 mg initially; subsequently administer 400 mg at 6 hours, 24 hours, and 48 hours after the initial dose (total dosage = 2000 mg). • Pediatric patients ≥ 31 kg: Administer 13 mg/kg (up to 800 mg) initially; subsequently administer 6.5 mg/kg (up to 400 mg) at 6 hours, 24 hours, and 48 hours after the initial dose (total dosage = 31 mg/kg - up to 2000 mg). For radical cure of P. vivax and P.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Hydroxychloroquine side effects
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Common side effects
- Nausea
- Vomiting
- Diarrhea
- Stomach pain
- Fatigue
- Headache
- Dizziness
- Loss of appetite
When to get medical help
- Call your doctor right away if you have blurred vision, vision changes or trouble seeing. Eye damage can be permanent.
- Get help right away for fainting, a racing or irregular heartbeat, or signs of heart trouble.
- Seek medical care promptly for blisters on the skin, eyes, lips or mouth, itching or burning, with or without fever.
- Tell your doctor about new or worsening depression, mood changes or suicidal thoughts.
- Seek help for signs of low blood sugar, such as shakiness, sweating or confusion.
- Call your doctor for fatigue, rash, nausea, dark urine or yellowing of the skin or eyes, which may signal liver problems.
- Report muscle weakness or nerve problems.
- Report unusual bruising, bleeding, or signs of low blood counts.
The most common side effects are stomach-related.
- Nausea
- Vomiting
- Diarrhea
- Stomach pain
- Fatigue, headache and dizziness
Call your doctor promptly for vision changes, heart rhythm symptoms, severe skin reactions, mood changes or suicidal thoughts, signs of low blood sugar, or liver symptoms.
Hydroxychloroquine warnings and precautions
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- Heart: serious heart muscle disease and dangerous rhythms (QT prolongation) have been reported. Do not exceed the recommended dose.
- Eyes: permanent retinal damage can occur, linked to higher dose, longer use, kidney problems, tamoxifen and existing macular disease. Eye exams are recommended.
- Skin: serious reactions such as Stevens-Johnson syndrome have been reported, and psoriasis may flare.
- Blood, muscle, nerve and kidney: low blood counts, weakness, nerve problems and kidney injury can occur.
- Mood and blood sugar: suicidal thoughts and severe low blood sugar have been reported.
- Porphyria and G6PD deficiency: the drug may worsen porphyria, cause liver injury in porphyria cutanea tarda, and cause hemolysis in G6PD deficiency.
Hydroxychloroquine interactions
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Tell your pharmacist about all your medicines.
- QT-prolonging drugs: higher risk of dangerous heart rhythms.
- Insulin and diabetes medicines: low blood sugar risk is higher.
- Mefloquine: may raise seizure risk.
- Antiepileptics: may work less well.
- Methotrexate: may increase side effects.
- Cyclosporine and digoxin: levels may rise.
- Cimetidine and rifampicin: avoid.
- Antacids and kaolin: may reduce absorption.
Interactions listed in the FDA-approved label
From the Hydroxychloroquine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Drugs prolonging QT interval and other arrhythmogenic drugs: Hydroxychloroquine prolongs the QT interval, and there may be an increased risk of inducing ventricular arrhythmias with other arrhythmogenic drugs. Not recommended in patients taking other drugs that have the potential to prolong the QT interval or are arrhythmogenic.
- Insulin or other antidiabetic drugs: Hydroxychloroquine may enhance the effects of insulin and antidiabetic drugs and increase the hypoglycemic risk. A decrease in dosage of insulin and other antidiabetic drugs may be necessary.
- Drugs that lower the seizure threshold (e.g., mefloquine): Hydroxychloroquine can lower the seizure threshold; co-administration with other antimalarials known to lower it may increase the risk of seizures.
- Antiepileptics: The activity of antiepileptic drugs might be impaired if co-administered with hydroxychloroquine.
- Methotrexate: Concomitant use may increase the incidence of adverse reactions.
- Cyclosporine: An increased plasma cyclosporine level was reported when co-administered. Monitor serum cyclosporine levels closely in patients receiving combined therapy.
- Digoxin: Concomitant therapy may result in increased serum digoxin levels. Monitor serum digoxin levels closely in patients receiving combined therapy.
- Cimetidine: Cimetidine resulted in a 2-fold increase of exposure of chloroquine, which is structurally related to hydroxychloroquine; interaction with hydroxychloroquine cannot be ruled out. Avoid concomitant use of cimetidine.
- Rifampicin: Lack of efficacy of hydroxychloroquine was reported when rifampicin was concomitantly administered. Avoid concomitant use of rifampicin.
- Antacids and kaolin: Antacids and kaolin can reduce absorption of chloroquine; interaction with hydroxychloroquine cannot be ruled out. An interval of at least 4 hours between intake of these agents and chloroquine should be observed.
Read the label’s full interactions text
7 DRUG INTERACTIONS Drugs Prolonging QT Interval and Other Arrhythmogenic Drugs. ( 7.1 ) See FPI for more important drug interactions. ( 7 ) 7.1 Drugs Prolonging QT Interval and Other Arrhythmogenic Drugs Hydroxychloroquine sulfate tablets prolongs the QT interval. There may be an increased risk of inducing ventricular arrhythmias if hydroxychloroquine sulfate tablets are used concomitantly with other arrhythmogenic drugs. Therefore, hydroxychloroquine sulfate tablets are not recommended in patients taking other drugs that have the potential to prolong the QT interval or are arrhythmogenic [see Warnings and Precautions (5.1) ]. 7.2 Insulin or Other Antidiabetic Drugs Hydroxychloroquine sulfate tablets may enhance the effects of insulin and antidiabetic drugs, and consequently increase the hypoglycemic risk. Therefore, a decrease in dosage of insulin and other antidiabetic drugs may be necessary [see Warnings and Precautions (5.10) ]. 7.3 Drugs that Lower the Seizure Threshold Hydroxychloroquine sulfate tablets can lower the seizure threshold. Co-administration of hydroxychloroquine sulfate tablets with other antimalarials known to lower the seizure threshold (e.g., mefloquine) may increase the risk of seizures. 7.4 Antiepileptics The activity of antiepileptic drugs might be impaired if co-administered with hydroxychloroquine sulfate tablets. 7.5 Methotrexate Concomitant use of hydroxychloroquine sulfate tablets and methotrexate may increase the incidence of adverse reactions. 7.6 Cyclosporine An increased plasma cyclosporine level was reported when cyclosporine and hydroxychloroquine sulfate tablets were co-administered. Monitor serum cyclosporine levels closely in patients receiving combined therapy. 7.7 Digoxin Concomitant hydroxychloroquine sulfate tablets and digoxin therapy may result in increased serum digoxin levels. Monitor serum digoxin levels closely in patients receiving combined therapy.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Hydroxychloroquine
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- Do not use if you are allergic to 4-aminoquinoline compounds.
- Tell your doctor about heart, eye, kidney, liver, psoriasis, porphyria, G6PD deficiency or diabetes history.
- Pregnancy: long experience and published data have not identified a drug-associated risk of major birth defects or miscarriage, and untreated disease also carries risks.
- Breastfeeding: low levels pass into milk, and no adverse effects in infants have been reported.
- Children: safe and effective for malaria, but not established for arthritis or lupus. Most tablets cannot be used under 31 kg.
- Older adults: start at the lowest dose, since kidney, liver or heart function may be reduced.
Hydroxychloroquine overdose
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Overdose symptoms can start within 1 to 3 hours. They can include serious heart rhythm problems, very low blood pressure, low potassium, seizures, vision problems and coma. Get emergency help right away or call a poison center at 1-800-221-2222.
What Hydroxychloroquine does in the body
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The relationship between drug levels and the safety and effectiveness of hydroxychloroquine, and how quickly its effects develop, has not been fully characterized. It does have the potential to prolong the QT interval, and the effect may increase with higher drug levels.
How your body processes Hydroxychloroquine
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After you swallow it, hydroxychloroquine is absorbed well, and blood levels peak in roughly 3 to 4 hours. It spreads widely into tissues. The body breaks it down with several liver enzymes. Some leaves unchanged through the kidneys.
It stays in the body a very long time, with a half-life of about 40 to 50 days in blood. Steady levels are reached after about 6 weeks of daily use in rheumatoid arthritis.
How to store Hydroxychloroquine
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Store at 20° to 25°C (68° to 77°F) and allow for excursions between 15°C and 30°C (59°F and 86°F) . Dispense in a tight, light-resistant container as defined in the USP/NF. Keep out of the reach of children.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Hydroxychloroquine
32 supplements and herbal products have documented interactions with Hydroxychloroquine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 7
- Moderate · 16
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Hydroxychloroquine: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Hydroxychloroquine — the kind of thing our pharmacy team would talk through with you at the counter.
What am I taking this for?
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How should I take it?
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What side effects are normal?
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Do I need eye exams?
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What should I watch for or call about?
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Can I take it with my other medicines?
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Is Hydroxychloroquine available over the counter?
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When was Hydroxychloroquine first available?
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Who makes Hydroxychloroquine?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Hydroxychloroquine on HelloPharmacist
Hydroxychloroquine forms and strengths (how it comes)
Hydroxychloroquine is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Plaquenil is used for uncomplicated malaria, malaria prevention, rheumatoid arthritis, systemic lupus erythematosus and chronic discoid lupus erythematosus.
- Sovuna is used for the same malaria, rheumatoid arthritis and lupus indications.
- Hydroxychloroquine tablets are used for the same malaria, rheumatoid arthritis and lupus indications.
- Plaquenil is taken by mouth with food or milk, and the tablets should not be crushed or divided.
- Sovuna is taken by mouth with food or milk, and the tablets should not be crushed.
- Hydroxychloroquine tablets are taken by mouth with food or milk, and should not be crushed or divided.
Hydroxychloroquine on the U.S. market: products, makers and brands
How Hydroxychloroquine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
54 companies list 159 Hydroxychloroquine product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 1955. Brand names on the directory include Plaquenil, Sovuna; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (14) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Hydroxychloroquine is used (Medicaid data)
A general measure of how commonly Hydroxychloroquine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Hydroxychloroquine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Hydroxychloroquine prescribed? Of the 1,601 medications we measure, Hydroxychloroquine ranks #221 by Medicaid prescriptions — more than 86% of them.
Utilization by Hydroxychloroquine product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
hydroxychloroquine sulfate 200 MG Oral Tablet Most dispensed
Summed across the 21 of 213 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 979092
hydroxychloroquine sulfate 300 MG Oral Tablet
Summed across the 2 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2569283
hydroxychloroquine sulfate 100 MG Oral Tablet
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2569281
hydroxychloroquine sulfate 400 MG Oral Tablet
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1119312
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Hydroxychloroquine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 25 of 228 listed Hydroxychloroquine NDCs with Medicaid activity.
Compare Hydroxychloroquine products
A representative set of FDA-listed product records for Hydroxychloroquine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 200 mg | Oral | A-S Medication Solutions × 14 listings | ANDA | View NDC → |
| 200 mg | Oral | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Find on DailyMed ↗ |
| 100 mg | Oral | Accord Healthcare, Inc., × 3 listings | ANDA | View NDC → |
| 200 mg | Oral | Accord Healthcare, Inc., × 3 listings | ANDA | View NDC → |
| 300 mg | Oral | Accord Healthcare, Inc., × 3 listings | ANDA | View NDC → |
| 400 mg | Oral | Accord Healthcare, Inc., × 3 listings | ANDA | View NDC → |
| 200 mg | Oral | Advanz Pharma (US) Corp. | NDA | View NDC → |
| 200 mg | Oral | American Health Packaging × 3 listings | ANDA | View NDC → |
| 200 mg | Oral | Amneal Pharmaceuticals NY LLC × 6 listings | ANDA | View NDC → |
| 200 mg | Oral | ANI Pharmaceuticals, Inc. × 2 listings | NDA | View NDC → |
| 300 mg | Oral | ANI Pharmaceuticals, Inc. × 2 listings | NDA | View NDC → |
| 200 mg | Oral | Aphena Pharma Solutions - Tennessee, LLC × 3 listings | NDA | View NDC → |
| 200 mg | Oral | Aphena Pharma Solutions - Tennessee, LLC × 5 listings | ANDA | View NDC → |
| 200 mg | Oral | Aphena Pharma Solutions - Tennessee, LLC | NDA AUTHORIZED GENERIC | View NDC → |
| 200 mg | Oral | Asclemed USA, Inc. × 2 listings | ANDA | View NDC → |
| 200 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 200 mg | Oral | AvPAK × 3 listings | ANDA | View NDC → |
| 200 mg | Oral | Bayshore Pharmaceuticals LLC × 2 listings | ANDA | View NDC → |
| 200 mg | Oral | Bryant Ranch Prepack × 16 listings | ANDA | View NDC → |
| 300 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 200 mg | Oral | Cardinal Health | ANDA | View NDC → |
| 200 mg | Oral | Cardinal Health 107, LLC × 4 listings | ANDA | View NDC → |
| 200 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 200 mg | Oral | Concordia Pharmaceuticals Inc. × 2 listings | NDA | View NDC → |
| 200 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 200 mg | Oral | Creekwood Pharmaceuticals LLC | ANDA | View NDC → |
| 200 mg | Oral | Doh Central Pharmacy | ANDA | View NDC → |
| 100 mg | Oral | Dr. Reddy's Laboratories Inc. × 3 listings | ANDA | View NDC → |
| 200 mg | Oral | Dr. Reddy's Laboratories Inc. × 3 listings | ANDA | View NDC → |
| 300 mg | Oral | Dr. Reddy's Laboratories Inc. × 3 listings | ANDA | View NDC → |
| 400 mg | Oral | Dr. Reddy's Laboratories Inc. × 3 listings | ANDA | View NDC → |
| 200 mg | Oral | Ipca Laboratories Limited | ANDA | View NDC → |
| 200 mg | Oral | Jubilant Cadista Pharmaceuticals Inc. | ANDA | View NDC → |
| 200 mg | Oral | Laurus Labs Limited × 3 listings | ANDA | View NDC → |
| 200 mg | Oral | Major Pharmaceuticals × 3 listings | ANDA | View NDC → |
| 200 mg | Oral | McKesson Corporation dba SKY Packaging × 2 listings | ANDA | View NDC → |
| 200 mg | Oral | Mylan Pharmaceuticals Inc. | ANDA | View NDC → |
| 200 mg | Oral | NCS HealthCare of KY, LLC dba Vangard Labs × 3 listings | ANDA | View NDC → |
| 200 mg | Oral | Northstar Rx LLC. × 3 listings | ANDA | View NDC → |
| 200 mg | Oral | Novitium Pharma LLC | NDA | View NDC → |
| 300 mg | Oral | Novitium Pharma LLC | NDA | View NDC → |
| 200 mg | Oral | NuCare Pharmaceuticals, Inc. | ANDA | View NDC → |
| 200 mg | Oral | NuCare Pharmaceuticals,Inc. × 4 listings | ANDA | View NDC → |
| 200 mg | Oral | Preferred Pharmaceuticals, Inc. × 3 listings | ANDA | View NDC → |
| 200 mg | Oral | Proficient Rx LP | NDA | View NDC → |
| 200 mg | Oral | Quallent Pharmaceuticals Health LLC × 3 listings | ANDA | View NDC → |
| 200 mg | Oral | RedPharm Drug, Inc. | NDA | View NDC → |
| 200 mg | Oral | RedPharm Drug, Inc. | ANDA | View NDC → |
| 200 mg | Oral | Rising Pharma Holdings, Inc. × 4 listings | ANDA | View NDC → |
| 200 mg | Oral | RPK Pharmaceuticals, Inc. | ANDA | Find on DailyMed ↗ |
| 200 mg | Oral | Sandoz Inc × 2 listings | ANDA | View NDC → |
| 200 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 200 mg | Oral | Teva Pharmaceuticals USA, Inc. × 2 listings | ANDA | View NDC → |
| 200 mg | Oral | Zydus Lifesciences Limited × 2 listings | ANDA | View NDC → |
| 200 mg | Oral | Zydus Pharmaceuticals (USA) Inc. | ANDA | View NDC → |
| 200 mg | Oral | Zydus Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | Chongqing Kangle Pharmaceutical Co., Ltd. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Dasami Lab Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Dr. Reddys Laboratories Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | EUROAPI Hungary Ltd. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Fermion Oy | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Ipca Laboratories Limited × 2 listings | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | MSN Life Sciences Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Professional Compounding Centers of America | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
| 1 kg/kg | — | SCI Pharmtech, Inc. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | SMS Pharmaceuticals Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Symed Labs Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Viyash Scientific Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Zydus Lifesciences Limited | BULK INGREDIENT | View NDC → |
Showing 159 of 159 products — FDA National Drug Code Directory. See every product, package size and price: browse all 159 Hydroxychloroquine NDCs →
Hydroxychloroquine side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Hydroxychloroquine — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Hydroxychloroquine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Hydroxychloroquine FDA approval history
How Hydroxychloroquine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Hydroxychloroquine recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Hydroxychloroquine recalls since July 2021.
✅No Hydroxychloroquine recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 5521 1 dose form · 4 strengths
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Dose form (SCDF) Oral Tablet RxCUI 370656In current FDA listingsClinical drug / strength (SCD) sulfate 100 MGRxCUI 2569281sulfate 200 MGRxCUI 979092sulfate 300 MGRxCUI 2569283sulfate 400 MGRxCUI 1119312
Look up RxCUI 5521 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Hydroxychloroquine supply and shortage status
Whether Hydroxychloroquine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Hydroxychloroquine brand names
Hydroxychloroquine is sold under 2 brand names in the FDA directory — Plaquenil, Sovuna. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Hydroxychloroquine: manufacturers and labelers
40 companies list Hydroxychloroquine products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, A-S Medication Solutions, Accord Healthcare, Inc.,. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 16 more on the FDA NDC directory.
Hydroxychloroquine drug class (RxNorm)
Hydroxychloroquine belongs to the Antimalarial class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Hydroxychloroquine page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Chartwell RX, LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →