NDC 67296-1780-1 (67296-1780-01) — Hydroxychloroquine Sulfate 200 mg

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 67296-1780-1

Product NDC 67296-1780

11-digit billing NDC 67296178001

Application # ANDA040104

SPL Set ID a3c2b92b-1bb7-d83c-e053-2a95a90a8fc2

Established class (EPC) Antimalarial [EPC], Antirheumatic Agent

DEA schedule Non-controlled

Marketing category ANDA

Marketing status Discontinued

FDA listing status Inactivated by FDA (certified through Dec 2023)

Route ORAL

Dosage form TABLET, FILM COATED

Substance HYDROXYCHLOROQUINE SULFATE

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 67296-1780-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 67296-1780-01. 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.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 3, 2026
RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
Medi-Span GPI (licensed)
First Databank (licensed) · refreshed Oct 1, 2026

Clinical

📗 Our plain-language guide HelloPharmacist

Hydroxychloroquine treats and prevents malaria, and treats rheumatoid arthritis, systemic lupus and chronic discoid lupus in adults. Your prescriber chose it for your specific cond...
Take it by mouth with food or milk, and swallow the tablet without crushing it. For lupus or arthritis it is usually daily. For malaria prevention it is weekly on the same day, sta...
Stomach upset is the most common, including nausea, vomiting, diarrhea and belly pain. Taking it with food can help. Call us if side effects are severe or don't settle.
Yes. Hydroxychloroquine can cause permanent retinal damage, especially with higher doses, longer use or kidney problems. A baseline eye exam in the first year is recommended, then...

📖 Read our full Hydroxychloroquine guide →

Patient education

📘 MedlinePlus patient leaflet ↗

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.

MedlinePlus (NLM) · refreshed Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 3, 2026

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 system	Per each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

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.

CMS NADAC weekly file
CMS ASP pricing files · refreshed Sep 20, 2026
CMS Medicaid State Drug Utilization Data · refreshed Oct 4, 2026
CMS Part D plan pricing files · refreshed Sep 24, 2026
VA National Acquisition Center price file

Packaging — all sizes for this product

Package NDC	Description	Marketing start	Marketing end	Status
67296-1780-01 You're viewing this Main listing	12 TABLET, FILM COATED in 1 BOTTLE	2020-01-01	—	Inactivated by FDA

Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Hydroxychloroquine Sulfate 200 mgthis 67296-1780-01	RedPharm	12 tablets	—	AB	Discontinued	—

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.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA Orange Book · refreshed Oct 3, 2026
CMS NADAC weekly file

Availability & generic status

📍

2026

Currently FDA-listed

listed with the FDA

🔓

·

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.

FDA Orange Book · refreshed Oct 3, 2026

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.

Where does this data come from?

Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

FDA label on DailyMed · label index refreshed Oct 3, 2026
FDA openFDA NDC Directory · synced Oct 1, 2026

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerRedPharm Drug, Inc.

Application holderSANDOZ INC

FDA applicationANDA040104 (ANDA)

Labeler code67296

Product typeHuman Prescription Drug

Portfolio26 products on file

More NDCs from RedPharm Drug, Inc. labeler code 67296

🔎 All NDCs from RedPharm Drug, Inc.

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.

FDA openFDA NDC Directory · synced Oct 1, 2026
Drugs@FDA

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel

🎯 Indications and Usage ~1 min read ▾

INDICATIONS AND USAGE Malaria Hydroxychloroquine sulfate is indicated for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax . Hydroxychloroquine sulfate is indicated for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported. Limitations of Use in Malaria • Hydroxychloroquine sulfate is not recommended for the treatment of complicated malaria. • Hydroxychloroquine sulfate is not effective against chloroquine or hydroxychloroquine-resistant strains of Plasmodium species (see CLINICAL PHARMACOLOGY – Microbiology ).

Hydroxychloroquine sulfate is 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 is not recommended for malaria prophylaxis in geographic areas where chloroquine resistance occurs. • Hydroxychloroquine sulfate 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 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 is indicated for the treatment of chronic discoid lupus erythematosus and systemic lupus erythematosus in adults. Rheumatoid Arthritis Hydroxychloroquine sulfate is indicated for the treatment of acute and chronic rheumatoid arthritis in adults.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION One tablet of 200 mg of hydroxychloroquine sulfate is equivalent to 155 mg base. Take hydroxychloroquine sulfate 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.

⛔ Contraindications 15 words ▾

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

⚠️ Warnings ~3 min read ▾

WARNINGS Resistant Strains of Malaria Hydroxychloroquine sulfate is 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 >6.5 mg/kg (5 mg/kg base) of actual body weight, durations of use >5 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. 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 >5 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 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 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 may prevent life-threatening complications. Hydroxychloroquine sulfate prolongs the QT interval.

Ventricular arrhythmias and torsades de pointes have been reported in patients taking hydroxychloroquine sulfate (see OVERDOSAGE ). Therefore, hydroxychloroquine sulfate 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 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 with vacuolar changes. Assess muscle strength and deep tendon reflexes periodically in patients on long-term therapy w… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS The following adverse reactions have been identified during post-approval use of hydroxychloroquine sulfate or other 4-aminoqunoline 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 prolongs the QT interval.

Ventricular arrhythmias and torsades de pointes have been reported in patients taking hydroxychloroquine sulfate (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 may precipitate attacks of psoriasis. It may be associated with pyrexia and hyperleukocytosis.

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🆘 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 to healthy males, 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 as 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), desethylchloroquine (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 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 Mechanism of Action The mech… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 100 words ▾

HOW SUPPLIED Hydroxychloroquine sulfate tablets, USP for oral administration are available as: 200 mg: Round, Off White, Standard Cup Tablet Core, Debossed GG 260 on One Side and Plain on the Reverse Side, Film Coated White NDC 0781-5994-01 bottles of 100 NDC 0781-5994-05 bottles of 500 Each tablet contains 200 mg hydroxychloroquine sulfate, USP (equivalent to 155 mg base). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not crush or divide hydroxychloroquine sulfate film-coated tablets, USP (see DOSAGE AND ADMINISTRATION ).

Dispense in a tight, light-resistant container. KEEP OUT OF THE REACH OF CHILDREN.

📦 Storage and Handling 41 words ▾

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not crush or divide hydroxychloroquine sulfate film-coated tablets, USP (see DOSAGE AND ADMINISTRATION ). Dispense in a tight, light-resistant container. KEEP OUT OF THE REACH OF CHILDREN.

📋 Description 74 words ▾

DESCRIPTION Hydroxychloroquine sulfate, USP is a colorless crystalline solid, soluble in water to at least 20 percent; chemically the drug is 2-[[4-[(7-Chloro-4-quinolyl) amino] pentyl] ethylamino] ethanol sulfate (1:1). Hydroxychloroquine sulfate has the following structural formula: Each tablet for oral administration contains 200 mg hydroxychloroquine sulfate, USP (equivalent to 155 mg hydroxychloroquine). Inactive ingredients: Dibasic calcium phosphate, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, povidone, sodium bicarbonate, and titanium dioxide.

Hydroxychloroquine Sulfate Chemical Structure

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Use with caution in patients with gastrointestinal, neurological, or blood disorders, and in those with a sensitivity to quinine. Hepatic/Renal Disease Antimalarial compounds should be used with caution in patients with hepatic disease or alcoholism or in conjunction with known hepatotoxic drugs. A reduction in dosage may be necessary in patients with hepatic or renal disease, as well as in those taking medicines known to affect these organs.

Hematologic Effects/Laboratory Tests Antimalarial compounds should be used with caution in patients with hepatic disease or alcoholism or in conjunction with known hepatotoxic drugs. Periodic blood cell counts should be performed if patients are given prolonged therapy. If any severe blood disorder such as aplastic anemia, agranulocytosis, leukopenia, or thrombocytopenia, appears which is not attributable to the disease under treatment, consider discontinuation of hydroxychloroquine sulfate.

Hydroxychloroquine sulfate should be administered with caution in patients having glucose-6-phosphate dehydrogenase (G-6-PD) deficiency. Dermatologic Effects Dermatologic reactions to hydroxychloroquine sulfate may occur and, therefore, proper care should be exercised when it is administered to any patient receiving a drug with a significant tendency to produce dermatitis. Drug Interactions Digoxin Concomitant hydroxychloroquine sulfate 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 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 prolongs 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 is used concomitantly with other arrhythmogenic drugs.

Mefloquine and Other Drugs Known to Lower the Convulsive Threshold Hydroxychloroquine sulfate can lower the convulsive threshold. Co-administration of hydroxychloroquine sulfate 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.

Methotrexate Combined use of methotrexate with hydroxychloroquine sulfate 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 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. 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, especially in pregnancy and in children.

Carcinogenesis, Mutagenesis, Impairment… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 22 words ▾

200 mg Label NDC 0781-5994-01 Hydroxychloroquine Sulfate Tablets, USP 200 mg Rx only 100 Tablets SANDOZ 200mgx100Tablets.jpg

Package Label.Principal Display Panel label

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

systemic lupus erythematosus: A long-term autoimmune disease in which the immune system attacks the body's own tissues, affecting joints, skin, kidneys, and other organs.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agranulocytosis: A severe drop in a certain type of infection-fighting white blood cell, greatly raising the risk of serious infections.

alopecia: Loss of hair from the scalp or body.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

aplastic anemia: A serious condition where the bone marrow stops making enough new blood cells.

ataxia: Loss of muscle coordination that makes walking, balance, and controlled movements clumsy or unsteady.

atrioventricular block: A slowing or blocking of the electrical signals traveling between the heart's upper and lower chambers, which can slow the heartbeat.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

bronchospasm: A sudden tightening of the muscles around the airways in the lungs that narrows them and makes breathing harder.

cardiac arrest: A sudden stop of the heart's pumping that cuts off blood flow to the body, which is a medical emergency.

cardiomyopathy: A disease of the heart muscle that makes it harder for the heart to pump blood.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

convulsion: Uncontrolled, rapid shaking of the body caused by muscles rapidly tightening and relaxing, often during a seizure.

creatinine clearance: An estimate of how fast the kidneys filter waste from the blood, often used to choose the right medicine dose.

depression: A lasting low mood with loss of interest that affects everyday life.

dermatitis: Inflammation of the skin, causing redness, itching, and sometimes swelling or blisters.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

DRESS syndrome: A rare, serious reaction with rash, fever, swollen glands, and inflammation of internal organs, sometimes appearing weeks after starting a medicine.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyskinesia: Involuntary, uncontrolled movements of the face, arms, legs, or body.

dystonia: Involuntary muscle contractions that cause twisting movements or abnormal, sometimes painful, body postures.

edema: Swelling caused by extra fluid trapped in the body's tissues.

emotional lability: Rapid, exaggerated mood changes that shift quickly from one feeling to another.

eosinophilia: A higher-than-normal level of eosinophils, a type of white blood cell often linked to allergies or drug reactions.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

erythema multiforme: A skin reaction with red, target-shaped spots, usually on the hands, arms, or face.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hemolysis: The breaking apart of red blood cells, which can lower the number of cells available to carry oxygen.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hypoglycemia: Low blood sugar, when the amount of glucose (sugar) in the blood drops below the normal range.

hypokalemia: A lower-than-normal level of potassium, an important mineral, in the blood.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

infusion: Slowly delivering fluid or medicine into a vein over a period of time, usually through a drip.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

irritability: Getting annoyed, frustrated, or angry more easily than usual.

leukopenia: A low level of white blood cells, the cells that help the body fight off infections.

liver function tests: Blood tests that check how well the liver is working and whether it is irritated or damaged.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

metabolic acidosis: A condition where too much acid builds up in the body's blood and fluids.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

metabolite: A new substance formed when the body breaks a medicine down.

myopathy: A disease of the muscles that can make them weak, painful, or tender.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

nystagmus: Rapid, involuntary back-and-forth movements of the eyes that a person cannot control.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

photophobia: Discomfort or pain in the eyes when exposed to light.

photosensitivity: An unusually strong skin reaction, such as burning or rash, after being in sunlight or other ultraviolet light.

prophylaxis: Treatment given to prevent an infection or illness before it starts, rather than to treat one that is already present.

pruritus: Itching of the skin.

psychosis: A state of losing touch with reality, such as seeing or hearing things that are not there or holding false beliefs.

pulmonary hypertension: High blood pressure in the arteries that carry blood from the heart to the lungs.

pyrexia: A raised body temperature; a fever.

QT prolongation: A longer-than-normal electrical recovery time between heartbeats, seen on a heart tracing (ECG), which can raise the chance of a dangerous heart rhythm.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

retinopathy: Damage to the retina, the light-sensing layer at the back of the eye, which can affect vision.

Rx only: A label marking meaning the medicine can be obtained only with a prescription from a licensed health professional.

seizure: A sudden burst of abnormal electrical activity in the brain that can cause shaking, staring, confusion, or loss of awareness.

Stevens-Johnson syndrome: A rare, serious reaction causing painful blistering and peeling of the skin and the moist linings of the mouth, eyes, and other areas.

subcutaneous: An injection placed into the fatty layer just under the skin; often written as subcut or SC.

suicidal behavior: Actions a person takes to try to end their own life, or steps taken in preparation for it.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

terminal half-life: The time it takes blood levels to fall by half during the final, slowest stage of removal.

thrombocytopenia: A low level of platelets, the blood cells that help form clots, which can lead to easier bruising or bleeding.

tinnitus: Ringing, buzzing, or other noise in the ears that is not coming from an outside sound.

torsades de pointes: A rare but dangerous fast heart rhythm that can cause fainting and, in the worst cases, become life-threatening.

toxic epidermal necrolysis: A rare, life-threatening reaction in which large areas of the top layer of skin blister and peel away, like a severe burn.

tremor: Shaking or trembling of part of the body, such as the hands, that a person cannot control.

urticaria: Raised, itchy welts on the skin, commonly called hives.

ventricular fibrillation: A life-threatening, chaotic rhythm in the heart's lower chambers that stops the heart from pumping blood effectively.

vertigo: A spinning sensation that makes you feel like you or the room around you is moving.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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

Medicare Part D (outpatient prescription) spending for 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.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	— Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured)	— Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	✓ Available
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

What does the discontinued status mean for this NDC?

The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.

Who lists this product with the FDA?

RedPharm Drug, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

Related NDC lookups

🧪 All Hydroxychloroquine Sulfate NDCsSame ingredient 🏭 All RedPharm labeler NDCsLabeler code 67296 📚 All Antimalarial [EPC], Antirheumatic Agent NDCsDrug class

Hydroxychloroquine Sulfate 200 mg Tablet, Film Coated, 12-count — NDC 67296-1780-1 (Billing 67296-1780-01)

NDC database record

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

Clinical

Patient education

Supplement & herbal interactions

Pricing

Packaging — all sizes for this product

Therapeutic equivalents

Availability & generic status

Inactive Ingredients / Excipients

Inactive ingredient FAQ

Manufacturer & labeler

More NDCs from RedPharm Drug, Inc. labeler code 67296

Full prescribing information FDA SPL

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

About this NDC listing & data coverage

Questions about this listing