Prescription medicine
Hydroxychloroquine Brand names: Plaquenil, Sovuna
Hydroxychloroquine (Plaquenil) is a prescription medicine with an FDA approval on record since 1955. FDA's NDC Directory lists it from 28 generic labelers, and pharmacies paid $0.149 per hydroxychloroquine 200 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- A presentation discontinued
Check it at the source: the hydroxychloroquine FDA label on DailyMed (effective October 8, 2024, ANI Pharmaceuticals, Inc.); the NDA 9768 record on Drugs@FDA; every hydroxychloroquine label on DailyMed.
Highlights of the record
FDA label of October 8, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageSOVUNA is an antimalarial and antirheumatic indicated for the: Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients.
Forms and strengths
- 100 mg
- 200 mg
- 300 mg
- 400 mg
Film-coated tablet; tablet.
On the market
- Earliest approval on file
- April 18, 1955 Plaquenil, Advanz Pharma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 15 first September 30, 1994; 13 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 31 of which 28 under generic applications, 4 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.149 per tablet Hydroxychloroquine 200 mg tablet
- Shortage (FDA)
- None current 1 past records
- Recalls by its makers (FDA)
- 2 since 2013 0 Class I among all firms' recalls; latest September 25, 2013
- FAERS reports
- 151,392 through July 30, 2026
What is hydroxychloroquine used for?
From the label: indications and usageSOVUNA is an antimalarial and antirheumatic indicated for the: Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. (1.1) Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. (1.1) Treatment of rheumatoid arthritis in adults. (1.2) Treatment of systemic lupus erythematosus in adults. (1.3) Treatment of chronic discoid lupus erythematosus in adults. (1.4) Limitations of Use (1.1): SOVUNA is not recommended for the: Treatment of complicated malaria. […]
Conditions named in the indications of hydroxychloroquine's FDA labels, with every medicine labeled for each:
From other hydroxychloroquine labelsRheumatoid arthritis: Rheumatoid Arthritis SOVUNA is indicated for the treatment of acute and chronic rheumatoid arthritis in adults.
FDA pharmacologic class: Antimalarial and Antirheumatic Agent.
Source: FDA drug label (SOVUNA), ANI Pharmaceuticals, Inc., effective October 8, 2024 (SPL set dd441154-b196-4d4c-bc56-2e37f345ef8d), via openFDA; the full label on DailyMed
Is there a generic for hydroxychloroquine (Plaquenil)?
The FDA approved the first generic hydroxychloroquine on September 30, 1994. 15 generic applications are approved; 13 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists hydroxychloroquine from 28 labelers under a generic (ANDA) application and from 4 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1955 earliest approval on file
- 1994 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for hydroxychloroquine (Plaquenil)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.149 per Hydroxychloroquine 200 mg tablet, down 8% from $0.162 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Hydroxychloroquine 200 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Hydroxychloroquine 100 mg tablet | Generic | $0.189 per tablet | $5.67 | -6% |
| Hydroxychloroquine 200 mg tablet | Generic | $0.149 per tablet | $4.47 | -8% |
| Hydroxychloroquine 300 mg tablet | Generic | $0.530 per tablet | $15.91 | -0.8% |
| Hydroxychloroquine 400 mg tablet | Generic | $0.670 per tablet | $20.09 | -4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is hydroxychloroquine in shortage?
No hydroxychloroquine presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 1 record is all marked to be discontinued, the latest updated January 5, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Hydroxychloroquine Sulfate, Tablet, 200 mg (NDC 0093-2401-01) | Teva Pharmaceuticals USA, Inc. | To Be Discontinued | January 5, 2026 |
Every hydroxychloroquine presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has hydroxychloroquine been recalled?
The FDA's Enforcement Report lists 2 recalls naming hydroxychloroquine since 2013: 0 Class I (the most serious), 1 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| September 25, 2013 | Class III | Sandoz Incorporated | Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets, USP, 200mg, due to illegibility of the logo on some … |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling:Label Mixup; HYDROXYCHLOROQUINE SULFATE, Tablet, 200 mg may be potentially mislabeled as guanFACINE HCl, Tablet, 1 mg, NDC 00378116001, Pedigree … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the hydroxychloroquine label say about other medicines?
The hydroxychloroquine label names 8 other medicines in its interaction, contraindication or warning sections. The labels of 5 other medicines name hydroxychloroquine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Ampicillin | drug interactions | In a study of healthy volunteers, chloroquine significantly reduced the bioavailability of ampicillin. |
| Chloroquine | drug interactions | Concomitant use of cimetidine resulted in a 2-fold increase of exposure of chloroquine, which is structurally related to hydroxychloroquine. |
| Cimetidine | drug interactions | Concomitant use of cimetidine resulted in a 2-fold increase of exposure of chloroquine, which is structurally related to hydroxychloroquine. |
| Digoxin | drug interactions | Digoxin Concomitant SOVUNA and digoxin therapy may result in increased serum digoxin levels. |
| Mefloquine | drug interactions | Co-administration of SOVUNA with other antimalarials known to lower the seizure threshold (e.g., mefloquine) may increase the risk of seizures. |
| Methotrexate | drug interactions | Concomitant use of SOVUNA and methotrexate may increase the incidence of adverse reactions. |
| Praziquantel | drug interactions | Chloroquine has been reported to reduce the bioavailability of praziquantel. |
| Tamoxifen | warnings and precautions | Risk factors for retinal damage include daily hydroxychloroquine sulfate dosages ≥5 mg/kg of actual body weight, durations of use greater than five years, renal impairment, use of concomitant drug products such as tamoxifen citrate, and concurrent macular disease. |
Other labels that name hydroxychloroquine
Source: FDA drug label (SOVUNA), ANI Pharmaceuticals, Inc., effective October 8, 2024 (SPL set dd441154-b196-4d4c-bc56-2e37f345ef8d), via openFDA; the full label on DailyMed
What do FAERS reports show for hydroxychloroquine?
The FDA Adverse Event Reporting System holds 151,392 reports that list hydroxychloroquine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 11,802 are coded as a death and 39,120 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as hydroxychloroquine?
9 other medicines are given the same way (oral) and in the same FDA class as hydroxychloroquine or labeled mainly for the same use (rheumatoid arthritis), the same class first. Rheumatoid arthritis lists all 46 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Leflunomide | Rheumatoid arthritis | 16 labelers | $0.324 per tablet 10 mg tablet | A presentation being discontinued |
| Penicillamine | Rheumatoid arthritis | 9 labelers | n/a | No current entry |
| Indomethacin | Rheumatoid arthritis | 25 labelers | $0.210 per capsule 75 mg capsule | No current entry |
| Tofacitinib | Rheumatoid arthritis | 24 labelers | $0.573 per tablet 5 mg tablet | No current entry |
| Methotrexate | Rheumatoid arthritis | 25 labelers | $0.158 per tablet 2.5 mg tablet | In shortage |
| Baricitinib | Rheumatoid arthritis | none listed | $92.54 per tablet 2 mg tablet | No current entry |
| Flurbiprofen | Rheumatoid arthritis | 3 labelers | $3.17 per tablet 100 mg tablet | No current entry |
| Upadacitinib | Rheumatoid arthritis | none listed | $229.31 per tablet 15 mg tablet | No current entry |
Every medicine labeled for the same conditions as hydroxychloroquine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does hydroxychloroquine compare with medicines for the same use?
6 side-by-side pages set hydroxychloroquine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to hydroxychloroquine
- 9 medicines for the same use
- Other antimalarials
- the pharmacologic class, with prices and generics
- Hydroxychloroquine side effects
- the label's list beside FAERS reports
- Hydroxychloroquine shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other