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HYDROXYCHLOROQUINE SULFATE 200 mg Tablet, Film Coated, 50-count — NDC 50268-0412-15 package photo

HYDROXYCHLOROQUINE SULFATE 200 mg Tablet, Film Coated, 50-count

by AvPAK · 50 BLISTER PACK in 1 BOX (50268-412-15) / 1 TABLET in 1 BLISTER PACK (50268-412-11)
NDC 50268-0412-15
🏷️ FDA NDC (as labeled) 50268-412-15 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 50268-412-15
Product NDC 50268-412
11-digit billing NDC 50268041215
NCPDP billing unit EA — each (per item)
RxCUI 979092
UNII 8Q2869CNVH
Application # ANDA210441
SPL Set ID a5b3455a-e842-7d4b-e053-2995a90adee3
Established class (EPC) Antimalarial; Antirheumatic Agent
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-05-15
Route ORAL
Dosage form TABLET, FILM COATED
Substance HYDROXYCHLOROQUINE SULFATE
GPI-14 13000020100305
GPI class Hydroxychloroquine Sulfate
GCN Seq No 009580
GCN 42940
HICL code 004151
Ingredient (HICL) Hydroxychloroquine Sulfate
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W4
Therapeutic class — intermediate (HIC2) Antiparasitics
HIC3 code W4A
Therapeutic class — specific (HIC3) Antimalarial Drugs
AHFS code 08:30.08.00
AHFS class Antimalarials
FDB label name HYDROXYCHLOROQUINE 200 MG TAB
FDB brand name Hydroxychloroquine Sulfate
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 50268-412-15 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 50268-0412-15. 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 Antimalarial class.

Pharmacologic class Antimalarial, Antirheumatic Agent
Drug family (ATC) Aminoquinolines
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.

🏭 Manufacturer & labeler

LabelerAvPAK
Application holderAPPCO PHARMA LLC
FDA applicationANDA210441 (ANDA)
Labeler code50268
First marketedMay 2020
Product typeHuman Prescription Drug
Portfolio346 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.

🩺 Clinical

Label name HYDROXYCHLOROQUINE 200 MG TAB Ingredient Hydroxychloroquine Sulfate
📖 What it is MedlinePlus · NLM

Hydroxychloroquine is used to prevent and treat acute attacks of malaria in adults and children weighing more than 31 kg (68 lbs). It is also used to treat discoid lupus erythematosus (DLE; a chronic inflammatory condition of the skin) or systemic lupus erythematosus (SLE or lupus; an autoimmune disease in which the immune system attacks healthy parts of the body such as joints, skin, blood vessels, and organs) and rheumatoid arthritis. Hydroxychloroquine is in a class of drugs called antimalarials and is also an antirheumatic drug. It works by killing the organisms that cause malaria. Hydroxy...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It has two main uses. First, it treats and helps prevent malaria — a parasitic infection spread by mosquitoes — in both adults and children. Second, it helps manage autoimmune cond...
  • What exactly is hydroxychloroquine used for?
  • Always take it by mouth with food or milk — this helps protect your stomach and reduces nausea. Don't crush or split the tablet unless your specific product allows it; check your l...
  • How should I take my hydroxychloroquine tablet?
📖 Read our full Hydroxychloroquine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

💊 What it looks like

Color white
ShapeOval
ImprintAC;384
Size12 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 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 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • 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.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

9 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.

💲 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 eaPer package
Retail pharmacies payNADAC · weekly $0.149 $7.43 / 50 tablet
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 $0.3275 $16.38 / 50 tablet
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.247 $0.149
▼ Down 34% over the last 24 months.
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hydroxychloroquine Sulfate 200 mg 00093-2401-01 Teva 100 tablets $0.149 AB Availability likely —
Hydroxychloroquine Sulfate 200 mg 00904-7046-06 Major 50 tablets $0.149 AB Availability likely —
Hydroxychloroquine Sulfate 200 mg 16571-0112-01 Rising 100 tablets $0.149 AB Availability likely —
Hydroxychloroquine sulfate 200 mg 16714-0110-01 Northstar 100 tablets $0.149 AB Availability likely —
Hydroxychloroquine Sulfate 200 mg 16729-0485-01 Accord 100 tablets $0.149 AB Availability likely —
Hydroxychloroquine Sulfate 200 mg 43598-0721-01 Dr. 100 tablets $0.149 AB Availability likely —
Hydroxychloroquine Sulfate 200 mgthis 50268-0412-15 AvPAK 50 tablets $0.149 AB Availability likely —
Hydroxychloroquine Sulfate 200 mg 59651-0889-01 Aurobindo 100 tablets $0.149 AB Availability likely —
Hydroxychloroquine 200 mg 62135-0752-90 Chartwell 90 tablets $0.149 AB Availability likely —
Hydroxychloroquine Sulfate 200 mg 68084-0269-01 American 1 tablet $0.149 AB Availability likely —
Hydroxychloroquine sulfate 200 mg 68382-0096-01 Zydus 100 tablets $0.149 AB Availability likely —
Hydroxychloroquine Sulfate 200 mg 69238-1544-01 Amneal 100 tablets $0.149 AB Availability likely —
Hydroxychloroquine sulfate 200 mg 82009-0045-05 Quallent 500 tablets $0.149 AB Availability likely —
Hydroxychloroquine Sulfate 200 mg 83980-0001-01 Ipca 100 tablets $0.149 AB Availability likely —
Hydroxychloroquine sulfate 200 mg 57664-0761-13 Sun 500 tablets $0.176 AB FDA listed +19%
Hydroxychloroquine sulfate 200 mg 00615-8459-39 NCS 30 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 42385-0971-01 Laurus 100 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 50090-4659-01 A-S 60 tablets — AB Discontinued —
Hydroxychloroquine sulfate 200 mg 50090-5573-00 A-S 30 tablets — AB Discontinued —
Hydroxychloroquine Sulfate 200 mg 50090-6280-01 A-S 60 tablets — AB FDA listed —
Hydroxychloroquine sulfate 200 mg 50090-6629-00 A-S 90 tablets — AB FDA listed —
Hydroxychloroquine sulfate 200 mg 50090-7306-01 A-S 60 tablets — AB FDA listed —
Hydroxychloroquine sulfate 200 mg 50090-7307-00 A-S 90 tablets — AB FDA listed —
Hydroxychloroquine sulfate 200 mg 55154-2074-00 Cardinal 1 tablet — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 55154-3567-00 Cardinal 10 tablets — AB FDA listed —
Plaquenil 200 mg 59212-0562-10 Advanz 100 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 60219-1544-01 Amneal 100 tablets — AB FDA listed —
Hydroxychloroquine sulfate 200 mg 65841-0633-01 Zydus 100 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 67046-1523-03 Coupler 30 tablets — AB FDA listed —
Hydroxychloroquine sulfate 200 mg 68071-2332-01 NuCare 100 tablets — AB FDA listed —
Hydroxychloroquine sulfate 200 mg 68071-3955-06 NuCare 60 tablets — AB FDA listed —
Hydroxychloroquine sulfate 200 mg 68788-7747-02 Preferred 20 tablets — AB FDA listed —
Sovuna 200 mg 70954-0804-10 ANI 30 tablets — — FDA listed —
Plaquenil 200 mg 71205-0448-12 Proficient 12 tablets — AB FDA listed —
Hydroxychloroquine sulfate 200 mg 71335-0897-01 Bryant 100 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 71335-1523-01 Bryant 100 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 71335-1771-01 Bryant 100 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 71335-2813-01 Bryant 100 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 71335-2814-01 Bryant 500 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 71335-3079-01 Bryant 100 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 71335-3113-01 Bryant 100 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 71335-3142-01 Bryant 100 tablets — AB FDA listed —
Plaquenil 200 mg 71610-0473-30 Aphena 30 tablets — AB FDA listed —
Hydroxychloroquine sulfate 200 mg 71610-0506-30 Aphena 30 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 71610-0701-53 Aphena 60 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 71610-0961-30 Aphena 30 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 72162-2467-01 Bryant 100 tablets — AB FDA listed —
Hydroxychloroquine sulfate 200 mg 76420-0850-01 Asclemed 100 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 82619-0131-01 Creekwood 100 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

🏛️
2020
On the market since
May 2020
📍
2026
Currently FDA-listed
6 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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Hydroxychloroquine Sulfate — the program that covers self-administered drugs. 14 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 Hydroxychloroquine Sulfate. 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
$25.3M
Claims incl. refills
636.2K
Beneficiaries
461.3K
Spend / beneficiary
$54.85
Spend / claim
$39.77
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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Hydroxychloroquine Sulfate — the ingredient across all brands.

Top reported reactions

Rheumatoid Arthritis20,475
Pain16,708
Fatigue14,220
Arthralgia13,930
Drug Intolerance12,434
Joint Swelling12,340
Rash10,770

Age at onset

Neonate159
Infant22
Child84
Adolescent85
Adult11,673
Elderly3,839

Reporter sex

90,575 reports
Male · 14%
Female · 86%
Unknown · 0%

Serious outcomes

Hospitalization22,527
Disabling8,441
Life-threatening6,079
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 5,322 1,894
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
50268-0412-15 You're viewing this 50 BLISTER PACK in 1 BOX (50268-412-15) / 1 TABLET in 1 BLISTER PACK (50268-412-11) 2020-05-15 Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage ~1 min read ▾

INDICATIONS AND USAGE Malaria Hydroxychloroquine Sulfate Tablets are indicated for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. ovale , and P. vivax. Hydroxychloroquine Sulfate Tablets are indicated for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported. Limitations of Use in Malaria Hydroxychloroquine Sulfate Tablets are not recommended for the treatment of complicated malaria.

Hydroxychloroquine Sulfate Tablets are not effective against chloroquine or hydroxychloroquine- resistant strains of Plasmodium species (see CLINICAL PHARMACOLOGY – Microbiology ). Hydroxychloroquine Sulfate Tablets are not recommended for the treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified. Hydroxychloroquine Sulfate Tablets are not recommended for malaria prophylaxis in geographic areas where chloroquine resistance occurs.

Hydroxychloroquine Sulfate Tablets does not prevent relapses of P. vivax or P. ovale because it is not active against the hypnozoite forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline compound is necessary (see CLINICAL PHARMACOLOGY – Microbiology ). Prior to prescribing hydroxychloroquine sulfate tablets for the treatment or prophylaxis of malaria, consult the Centers for Disease Control and Prevention (CDC) Malaria website ( http://www.cdc.gov/malaria ).

Lupus Erythematosus Hydroxychloroquine Sulfate Tablets are indicated for the treatment of chronic discoid lupus erythematosus and systemic lupus erythematosus in adults. Rheumatoid Arthritis Hydroxychloroquine Sulfate Tablets are indicated for the treatment of acute and chronic rheumatoid arthritis in adults.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION: One hydroxychloroquine sulfate tablet contains 200 mg of hydroxychloroquine sulfate, which is equivalent to 155 mg base. Take hydroxychloroquine sulfate tablets with a meal or a glass of milk. Malaria Prophylaxis Adults: 400 mg (310 mg base) once weekly on the same day of each week starting 2 weeks prior to exposure, and continued for 4 weeks after leaving the endemic area.

Weight-based dosing in adults and pediatric patients: 6.5 mg/kg (5 mg/kg base), not to exceed 400 mg (310 mg base), once weekly on the same day of the week starting 2 weeks prior to exposure, and continued for 4 weeks after leaving the endemic area. Treatment of Uncomplicated Malaria Adults: 800 mg (620 mg base) followed by 400 mg (310 mg base) at 6 hours, 24 hours and 48 hours after the initial dose (total 2000 mg hydroxychloroquine sulfate or 1550 mg base). Weight based dosage in adults and pediatric patients: 13 mg/kg (10 mg/kg base), not to exceed 800 mg (620 mg base) followed by 6.5 mg/kg (5 mg/kg base), not to exceed 400 mg (310 mg base), at 6 hours, 24 hours and 48 hours after the initial dose.

Hydroxychloroquine Sulfate film-coated tablets cannot be divided, therefore they should not be used to treat patients who weigh less than 31 kg. For radical cure of P. vivax and P. malariae infections, concomitant therapy with an 8-aminoquinoline compound is necessary. Lupus Erythematosus The recommended adult dosage is 200 to 400 mg (155 to 310 mg base) daily, administered as a single daily dose or in two divided doses.

Doses above 400 mg a day are not recommended. The incidence of retinopathy has been reported to be higher when this maintenance dose is exceeded. Rheumatoid Arthritis The action of hydroxychloroquine is cumulative and may require weeks to months to achieve the maximum therapeutic effect (see CLINICAL PHARMACOLOGY ).

Initial adult dosage: 400 mg to 600 mg (310 to 465 mg base) daily, administered as a single daily dose or in two divided doses. In a small percentage of patients, side effects may require temporary reduction of the initial dosage. Maintenance adult dosage: When a good response is obtained, the dosage may be reduced by 50 percent and continued at a maintenance level of 200 mg to 400 mg (155 to 310 mg base) daily, administered as a single daily dose or in two divided doses.

Do not exceed 600 mg or 6.5 mg/kg (5 mg/kg base) per day, whichever is lower, as the incidence of retinopathy has been reported to be higher when this maintenance dose is exceeded. Corticosteroids and salicylates may be used in conjunction with hydroxychloroquine sulfate tablets, and they can generally be decreased gradually in dosage or eliminated after a maintenance dose of hydroxychloroquine sulfate tablets has been achieved.

⛔ Contraindications 16 words ▾

CONTRAINDICATIONS Use of hydroxychloroquine sulfate tablets is contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds.

⚠️ Warnings ~2 min read ▾

WARNINGS: Resistant strains of malaria: Hydroxychloroquine Sulfate Tablets are not effective against chloroquine-resistant strains of P. falciparum (see CLINICAL PHARMACOLOGY – Microbiology ). Ocular: Irreversible retinal damage has been observed in some patients who had received hydroxychloroquine sulfate. Significant risk factors for retinal damage include daily doses of hydroxychloroquine sulfate greater than 6.5 mg/kg (5 mg/kg base) of actual body weight, durations of use greater than five years, subnormal glomerular filtration, use of some concomitant drug products such as tamoxifen citrate and concurrent macular disease.

A baseline ocular examination is recommended within the first year of starting hydroxychloroquine sulfate tablets. The baseline exam should include: best corrected distance visual acuity (BCVA), an automated threshold visual field (VF) of the central 10 degrees (with retesting if an abnormality is noted), and spectral domain ocular coherence tomography (SD-OCT). For individuals with significant risk factors (daily dose of hydroxychloroquine sulfate greater than 5.0 mg/kg base of actual body weight, subnormal glomerular filtration, use of tamoxifen citrate or concurrent macular disease) monitoring should include annual examinations which include BCVA, VF and SD-OCT.

For individuals without significant risk factors, annual exams can usually be deferred until five years of treatment. In individuals of Asian descent, retinal toxicity may first be noticed outside the macula. In patients of Asian descent, it is recommended that visual field testing be performed in the central 24 degrees instead of the central 10 degrees.

It is recommended that hydroxychloroquine be discontinued if ocular toxicity is suspected and the patient should be closely observed given that retinal changes (and visual disturbances) may progress even after cessation of therapy. Cardiac Effects, including Cardiomyopathy and QT prolongation: Postmarketing cases of life-threatening and fatal cardiomyopathy have been reported with use of hydroxychloroquine sulfate tablets as well as with use of chloroquine. Patients may present with atrioventricular block, pulmonary hypertension, sick sinus syndrome or with cardiac complications.

ECG findings may include atrioventricular, right or left bundle branch block. Signs or symptoms of cardiac compromise have appeared during acute and chronic treatment. Clinical monitoring for signs and symptoms of cardiomyopathy is advised, including use of appropriate diagnostic tools such as ECG to monitor patients for cardiomyopathy during hydroxychloroquine sulfate tablet therapy.

Chronic toxicity should be considered when conduction disorders (bundle branch block/atrio-ventricular heart block) or biventricular hypertrophy are diagnosed. If cardiotoxicity is suspected, prompt discontinuation of hydroxychloroquine sulfate tablets may prevent life-threatening complications. Hydroxychloroquine Sulfate Tablets prolongs the QT interval.

Ventricular arrhythmias and torsades de pointes have been reported in patients taking hydroxychloroquine sulfate tablets (see OVERDOSAGE ). Therefore, hydroxychloroquine sulfate tablets should not be administered with other drugs that have the potential to prolong the QT interval (see DRUG INTERACTIONS ). Worsening of psoriasis and porphyria: Use of hydroxychloroquine sulfate tablets in patients with psoriasis may precipitate a severe attack of psoriasis.

When used in patients with porphyria the condition may be exacerbated. The preparation should not be used in these conditions unless in the judgment of the physician the benefit to the patient outweighs the possible hazard. Proximal Myopathy and Neuropathy: Skeletal muscle myopathy or neuropathy leading to progressive weakness and atrophy of proximal muscle groups, depressed tendon reflexes, and abnormal nerve conduction, have been reported.

Muscle and nerve biopsies have been associated with curvilinear bodies and muscle fiber atrophy…

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS The following adverse reactions have been identified during post-approval use of hydroxychloroquine sulfate tablets or other 4-aminoquinoline compounds. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood and lymphatic system disorders: Bone marrow failure, anemia, aplastic anemia, agranulocytosis, leukopenia, and thrombocytopenia.

Hemolysis reported in individuals with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency. Cardiac disorders: Cardiomyopathy which may result in cardiac failure and in some cases a fatal outcome (see WARNINGS and OVERDOSAGE ). Hydroxychloroquine Sulfate Tablets prolong the QT interval.

Ventricular arrhythmias and torsade de pointes have been reported in patients taking hydroxychloroquine sulfate tablets (see OVERDOSAGE and DRUG INTERACTIONS ). Ear and labyrinth disorders: Vertigo, tinnitus, nystagmus, nerve deafness, deafness. Eye disorders: Irreversible retinopathy with retinal pigmentation changes (bull’s eye appearance), visual field defects (paracentral scotomas) and visual disturbances (visual acuity), maculopathies (macular degeneration), decreased dark adaptation, color vision abnormalities, corneal changes (edema and opacities) including corneal deposition of drug with or without accompanying symptoms (halo around lights, photophobia, blurred vision).

Gastrointestinal disorders: Nausea, vomiting, diarrhea, and abdominal pain. General disorders and administration site conditions: Fatigue. Hepatobiliary disorders: Liver function tests abnormal, hepatic failure acute.

Immune system disorders: Urticaria, angioedema, bronchospasm. Metabolism and nutrition disorders: Decreased appetite, hypoglycemia, porphyria, weight decreased. Musculoskeletal and connective tissue disorders: Sensorimotor disorder, skeletal muscle myopathy or neuromyopathy leading to progressive weakness and atrophy of proximal muscle groups, depression of tendon reflexes and abnormal nerve conduction.

Nervous system disorders: Headache, dizziness, seizure, ataxia and extrapyramidal disorders such as dystonia, dyskinesia, and tremor have been reported with this class of drugs. Psychiatric disorders: Affect/emotional lability, nervousness, irritability, nightmares, psychosis, suicidal behavior. Skin and subcutaneous tissue disorders: Rash, pruritus, pigmentation disorders in skin and mucous membranes, hair color changes, alopecia.

Dermatitis bullous eruptions including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), photosensitivity, dermatitis exfoliative, acute generalized exanthematous pustulosis (AGEP). AGEP has to be distinguished from psoriasis, although hydroxychloroquine sulfate tablets may precipitate attacks of psoriasis. It may be associated with pyrexia and hyperleukocytosis.

To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🔄 Drug Interactions ~1 min read ▾

Drug Interactions Digoxin: Concomitant hydroxychloroquine sulfate tablets and digoxin therapy may result in increased serum digoxin levels: serum digoxin levels should be closely monitored in patients receiving combined therapy. Insulin or antidiabetic drugs: As hydroxychloroquine sulfate tablets may enhance the effects of a hypoglycemic treatment, a decrease in doses of insulin or antidiabetic drugs may be required. Drugs that prolong QT interval and other arrhythmogenic drugs: Hydroxychloroquine Sulfate Tablets prolong the QT interval and should not be administered with other drugs that have the potential to induce cardiac arrhythmias.

Also, there may be an increased risk of inducing ventricular arrhythmias if hydroxychloroquine sulfate tablets is used concomitantly with other arrhythmogenic drugs. Mefloquine and other drugs known to lower the convulsive threshold: Hydroxychloroquine Sulfate Tablets can lower the convulsive threshold. Co-administration of hydroxychloroquine sulfate tablets with other antimalarials known to lower the convulsion threshold (e.g., mefloquine) may increase the risk of convulsions.

Antiepileptics: The activity of antiepileptic drugs might be impaired if co-administered with hydroxychloroquine sulfate tablets. Methotrexate: Combined use of methotrexate with hydroxychloroquine sulfate tablets has not been studied and may increase the incidence of adverse effects. Cyclosporin: An increased plasma cyclosporin level was reported when cyclosporin and hydroxychloroquine sulfate tablets were co-administered.

The following interactions have been observed on treatment with the structurally related substance chloroquine phosphate, and therefore cannot be ruled out for hydroxychloroquine. Praziquantel: Chloroquine has been reported to reduce the bioavailability of praziquantel. Antacids and kaolin: Antacids and kaolin can reduce absorption of chloroquine; an interval of at least 4 hours between intake of these agents and chloroquine should be observed.

Cimetidine: Cimetidine can inhibit the metabolism of chloroquine, increasing its plasma level. Concomitant use of cimetidine should be avoided. Ampicillin: In a study of healthy volunteers, chloroquine significantly reduced the bioavailability of ampicillin.

🤰 Pregnancy ~1 min read ▾

Pregnancy Teratogenic Effects: Human pregnancies resulting in live births have been reported in the literature and no increase in the rate of birth defects has been demonstrated. Embryonic deaths and malformations of anophthalmia and microphthalmia in the offspring have been reported when pregnant rats received large doses of chloroquine. Nursing Mothers: Caution should be exercised when administering hydroxychloroquine sulfate tablets to nursing women.

It has been demonstrated that hydroxychloroquine administered to nursing women is excreted in human milk and it is known that infants are extremely sensitive to the toxic effects of 4-aminoquinolines. Pediatric Use: Safety and efficacy have not been established in the chronic use of hydroxychloroquine sulfate tablets for systemic lupus erythematosus and juvenile idiopathic arthritis in children. Children are especially sensitive to the 4-aminoquinoline compounds.

Most reported fatalities followed the accidental ingestion of chloroquine, sometimes in small doses (0.75 g or 1 g in one 3-year-old child). Patients should be strongly warned to keep these drugs out of the reach of children (see OVERDOSAGE ). Geriatric Use: Clinical studies of hydroxychloroquine sulfate tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

However, this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function.

🆘 Overdosage ~1 min read ▾

OVERDOSAGE The 4-aminoquinoline compounds are very rapidly and completely absorbed after ingestion, and in accidental overdosage, or rarely with lower doses in hypersensitive patients, toxic symptoms may occur within 30 minutes. The symptoms of overdosage may include headache, drowsiness, visual disturbances, cardiovascular collapse, convulsions, hypokalemia, rhythm and conduction disorders including QT prolongation, torsades de pointes, ventricular tachycardia and ventricular fibrillation, followed by sudden potentially fatal respiratory and cardiac arrest.

Treatment is symptomatic and must be prompt. Immediate gastric lavage until the stomach is completely emptied is indicated. After lavage, activated charcoal is introduced by the stomach tube within 30 minutes of ingestion of the drug may inhibit further intestinal absorption.

To be effective, the dose of activated charcoal should be at least five times the estimated dose of hydroxychloroquine ingested. Consideration should be given to administering diazepam parenterally since studies suggest that it may be beneficial in reversing chloroquine and hydroxychloroquine cardiotoxicity. Respiratory support and shock management should be instituted as necessary.

Exchange transfusions are used to reduce the level of 4-aminoquinoline drug in the blood. A patient who survives the acute phase and is asymptomatic should be closely observed for at least six hours. Fluids may be forced and sufficient ammonium chloride (8 g daily in divided doses for adults) may be administered for a few days to acidify the urine.

This will promote urinary excretion in cases of both overdosage and sensitivity. However, caution must be exercised in patients with impaired renal function and/or metabolic acidosis.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY: Pharmacokinetics: Following a single 200 mg oral dose of hydroxychloroquine sulfate tablets to healthy male volunteers, the mean peak blood concentration of hydroxychloroquine was 129.6 ng/mL, reached in 3.26 hours with a half-life of 537 hours (22.4 days). In the same study, the plasma peak concentration was 50.3 ng/mL reached in 3.74 hours with a half-life of 2963 hours (123.5 days). Urine hydroxychloroquine levels were still detectable after 3 months with approximately 10% of the dose excreted as the parent drug.

Results following a single dose of a 200 mg tablet versus i.v. infusion (155 mg), demonstrated a half-life of about 40 days and a large volume of distribution. Peak blood concentrations of metabolites were observed at the same time was peak levels of hydroxychloroquine. The mean fraction of the dose absorbed was 0.74.

After administration of single 155 mg and 310 mg intravenous doses, peak blood concentrations ranged from 1161 ng/mL to 2436 ng/mL (mean 1918 ng/mL) following the 155 mg infusion and 6 months following the 310 mg infusion. Pharmacokinetic parameters were not significantly different over the therapeutic dose range of 155 mg and 310 mg indicating linear kinetics. Following chronic oral administration of hydroxychloroquine, significant levels of three metabolites, desethylhydroxychloroquine (DHCQ), esethylchloroquine (DCQ), and bidesethylhydroxychloroquine (BDCQ) have been found in plasma and blood, with DHCQ being the major metabolite.

The absorption half-life was approximately 3 to 4 hours and the terminal half-life ranged from 40 to 50 days. The long half-life can be attributed to extensive tissue uptake rather than through decreased excretion. Peak plasma levels of hydroxychloroquine were seen in about 3 to 4 hours.

Renal clearance in rheumatoid arthritis (RA) patients taking hydroxychloroquine sulfate tablets for at least six months seemed to be similar to that of the single dose studies in volunteers, suggesting that no change occurs with chronic dosing. Range for renal clearance of unchanged drug was approximately 16 to 30% and did not correlate with creatinine clearance; therefore, a dosage adjustment is not required for patients with renal impairment. In RA patients, there was large variability as to the fraction of the dose absorbed (i.e.

30 to 100%), and mean hydroxychloroquine levels were significantly higher in patients with less disease activity. Cellular levels of patients on daily hydroxychloroquine have been shown to be higher in mononuclear cells than polymorphonuclear leucocytes. Microbiology –Malaria Mechanism of action: The precise mechanism by which hydroxychloroquine exhibits activity against Plasmodium is not known.

Hydroxychloroquine, like chloroquine, is a weak base and may exert its effect by concentrating in the acid vesicles of the parasite and by inhibiting polymerization of heme. It can also inhibit certain enzymes by its interaction with DNA. Activity in vitro and in Clinical Infections: Hydroxychloroquine is active against the erythrocytic forms of chloroquine sensitive strains of Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale , and Plasmodium vivax.

Hydroxychloroquine is not active against the gametocytes and exoerythrocytic forms including the hypnozoite stage ( P. vivax and P. ovale ) of the Plasmodium parasites. Drug Resistance: P. falciparum strains exhibiting reduced susceptibility to chloroquine also show reduced susceptibility to hydroxychloroquine. Resistance of Plasmodium parasites to chloroquine is widespread (see INDICATIONS AND USAGE – Malaria ).

Patients in whom chloroquine or hydroxychloroquine have failed to prevent or cure clinical malaria or parasitemia, or patients who acquired malaria in a geographic area where chloroquine resistance is known to occur should be treated with another form of antimalarial therapy (see INDICATIONS AND USAGE – Malaria and WARNINGS ). Rheumatoid Arthritis and Systemic Lupus Erythematosus…

📦 How Supplied / Storage and Handling 128 words ▾

HOW SUPPLIED Hydroxychloroquine Sulfate Tablets, USP are white to off-white film-coated capsule shaped tablets debossed with “AC 384” on one side and plain on the other side. Each tablet contains 200 mg hydroxychloroquine sulfate (equivalent to 155 mg base). NDC 50268-412-15 (10 tablets per card, 5 cards per carton) For Institutional Use Only.

Dispensed in Unit Dose Package. Do not crush or divide hydroxychloroquine sulfate film-coated tablets, USP (see DOSAGE AND ADMINISTRATION ). Dispense in a tight, light-resistant container as defined in the USP/NF.

Keep out of the reach of children. Store at room temperature 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (59° and 86°F) [See USP Controlled Room Temperature]. Manufactured for: AvKARE Pulaski, TN 38478 Mfg.

Rev. 05/18 AV 05/20 (P) AvPAK

📋 Description 102 words ▾

DESCRIPTION: Hydroxychloroquine sulfate is a white or practically white, crystalline powder, freely soluble in water; practically insoluble in alcohol, chloroform, and in ether. The chemical name for hydroxychloroquine sulfate is 2-[[4-[(7-Chloro-4-quinolyl) amino]pentyl] ethylamino]ethanol Sulfate (1:1). Its structural formula is: The molecular weight of hydroxychloroquine sulfate is 433.95, and molecular formula is C 18 H 26 ClN 3 O.H 2 SO 4 .

Hydroxychloroquine Sulfate Tablets, USP contain 200 mg hydroxychloroquine sulfate, equivalent to 155 mg base, and are for oral administration. Inactive Ingredients: corn starch, crospovidone, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Chemical Structure

💬 Information for Patients 70 words ▾

Information for Patients: Patients should be informed of the early signs and symptoms of toxicity such as rash or visual changes. Patients must see their physicians promptly in case of the appearance of these or of any unusual effects. Periodic laboratory tests may be recommended in some patients. Patients should be fully informed of the potential risks of the use of hydroxychloroquine sulfate tablets, especially in pregnancy and in children.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 50268-0411-01 · AvPAK 50268-0430-15 · AvPAK →
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.