Medical emergency?Emergency? Call 911. Nearest emergency roomsNearest ERs

Español Near me My list Help
US Patient GuideUSA
Surprise me
Brand-name prescription medicine

Plaquenil

Generic name: Hydroxychloroquine sulfate

FDA application holder: Advanz Pharma

Strengths and generic versions Official label

Official data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the NDC Directory, Drugs@FDA, the official labels and recall reports; pharmacy costs come from the Centers for Medicare & Medicaid Services (CMS). Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or switch any medicine, including a switch between a brand and a generic.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

1Strengths and forms
12Same medicine, other names
1955FDA approval
0Recalls (FDA reports)

Quick answers

What is Plaquenil?
Plaquenil is a brand name of Hydroxychloroquine sulfate, a prescription medicine. The FDA NDC Directory lists 3 Plaquenil products in 1 strength and form.
Who makes Plaquenil?
Advanz Pharma holds the FDA application for Plaquenil (NDA009768, approved April 18, 1955). 2 other companies (repackagers or distributors) also list Plaquenil products.
Is there a generic or store brand of Plaquenil?
Yes. The FDA NDC Directory lists 12 other products with the same active ingredients, strength and form as a Plaquenil product, 12 of them generic. Ask your pharmacist whether one is right for you.
Has Plaquenil been recalled?
No recall linked to Plaquenil products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Plaquenil is

Each Plaquenil product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.

Hydroxychloroquine sulfate · prescription medicine

Strength and formProduct namesSame medicine, other namesLabel
hydroxychloroquine sulfate 200 mg
tablet (oral)		 Plaquenil 12 products, 7 companies DailyMed

Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Hydroxychloroquine sulfate →

FDA approval

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
FDA applications of Plaquenil products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
NDA009768Advanz PharmaApril 18, 19553

Companies that list Plaquenil

The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Plaquenil products.

Recalls

No recall linked to Plaquenil products (by their NDC code or label) appears in the FDA enforcement reports.

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026

Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.

Report an error → · Information for medicine makers