Quick answers
- What is Hydroxychloroquine sulfate used for?
- The FDA-approved label (Plaquenil, Advanz Pharma (US) Corp., April 9, 2026) says: “PLAQUENIL 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. • Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. • Treatment of rheumatoid arthritis in adults. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Hydroxychloroquine sulfate have a boxed warning?
- No. None of the 50 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Hydroxychloroquine sulfate?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated January 5, 2026). Ask your pharmacist about alternatives.
- Has Hydroxychloroquine sulfate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Hydroxychloroquine sulfate?
- 30 companies list prescription products of Hydroxychloroquine sulfate in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions and Aphena Pharma Solutions - Tennessee, LLC.
What Hydroxychloroquine sulfate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
PLAQUENIL 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. • Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. • Treatment of rheumatoid arthritis in adults. …
— FDA label: Plaquenil, Advanz Pharma (US) Corp., effective April 9, 2026. Read the full label on DailyMed →
The FDA has 50 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 50 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| hydroxychloroquine sulfate 100 mg tablet, film coated | Generic | $0.1923 per tablet |
| hydroxychloroquine sulfate 200 mg tablet | Generic | $0.1441 per tablet |
| hydroxychloroquine sulfate 200 mg tablet, film coated | Generic | $0.1441 per tablet |
| hydroxychloroquine sulfate 300 mg tablet, film coated | Generic | $0.5316 per tablet |
| hydroxychloroquine sulfate 400 mg tablet, film coated | Generic | $0.6954 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack10 products
- A-S Medication Solutions6 products
- Aphena Pharma Solutions - Tennessee, LLC5 products
- Accord Healthcare Inc.4 products
- Dr. Reddy's Laboratories Inc.4 products
- Cardinal Health 107, LLC2 products
- ANI Pharmaceuticals, Inc.2 products
- NuCare Pharmaceuticals, Inc.2 products
- Amneal Pharmaceuticals NY LLC2 products
- NCS HealthCare of KY, LLC dba Vangard Labs1 product
- Rising Pharma Holdings, Inc.1 product
- Laurus Labs Limited1 product
- American Health Packaging1 product
- Chartwell RX, LLC1 product
- Quallent Pharmaceuticals Health LLC1 product
- Major Pharmaceuticals1 product
- Creekwood Pharmaceuticals LLC1 product
- Aurobindo Pharma Limited1 product
- Zydus Lifesciences Limited1 product
- Zydus Pharmaceuticals USA Inc.1 product
- Sun Pharmaceutical Industries, Inc.1 product
- Advanz Pharma (US) Corp.1 product
- Proficient Rx LP1 product
- Ipca Laboratories Limited1 product
- Teva Pharmaceuticals USA, Inc.1 product
- AvPAK1 product
- NorthStar Rx LLC1 product
- Coupler LLC1 product
- Preferred Pharmaceuticals Inc.1 product
- Asclemed USA, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA009768 PLAQUENIL | Advanz Pharma | April 18, 1955 | 33, latest December 12, 2023 2023: Labeling · 2023: Labeling · 2022: Labeling |
| NDA214581 SOVUNA | Novitium Pharma | January 14, 2022 | 4, latest October 10, 2024 2024: Labeling · 2023: Labeling · 2023: Labeling |
Generic approvals (11)
- ANDA040081Teva Pharms · September 30, 1994
- ANDA040150Creekwood Pharms · January 27, 1996
- ANDA040274Aurobindo Pharma USA · May 29, 1998
- ANDA040766Ipca Labs Ltd · June 14, 2007
- ANDA040657Zydus Pharms USA Inc · September 21, 2007
- ANDA210441Appco · May 1, 2018
- ANDA201691Alkaloida Zrt · May 8, 2018
- ANDA210577Amneal Pharms Co · May 15, 2018
- ANDA210543Chartwell Rx · July 6, 2018
- ANDA210959Laurus · January 15, 2019
- ANDA213342Accord Hlthcare · April 7, 2020
Shortage status
To be discontinued · updated January 5, 2026 · first posted January 5, 2026
| Product | Hydroxychloroquine Sulfate, Tablet, 200 mg (NDC 0093-2401-01) |
|---|---|
| Company | Teva Pharmaceuticals USA, Inc. |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Plaquenil, Advanz Pharma (US) Corp., effective April 9, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →