Prescription medicine
Chloroquine First approved as Aralen
Chloroquine (Aralen) is a prescription medicine with an FDA approval on record since 1949. FDA's NDC Directory lists it from 4 generic labelers, and pharmacies paid $6.65 per chloroquine ph 500 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the chloroquine FDA label on DailyMed (effective July 2, 2026, Rising Pharma Holdings, Inc.); the NDA 6002 record on Drugs@FDA; every chloroquine label on DailyMed.
Highlights of the record
FDA label of July 2, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageChloroquine phosphate tablets are indicated for the: Treatment of uncomplicated malaria due to susceptible strains of P.
Forms and strengths
- 250 mg
- 500 mg
Tablet; coated tablet.
On the market
- Earliest approval on file
- October 31, 1949 Aralen, Sanofi Aventis Us; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 11 first December 11, 1974; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 4 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $6.65 per tablet Chloroquine ph 500 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 654 through July 30, 2026
What is chloroquine used for?
From the label: indications and usageChloroquine phosphate tablets are indicated for the: Treatment of uncomplicated malaria due to susceptible strains of P. falciparum, P.malariae, P. ovale, and P.vivax. Prophylaxis of malaria in geographic areas where resistance to chloroquine is not present. Treatment of extraintestinal amebiasis. Chloroquine phosphate tablets do not prevent relapses in patients with vivax or ovale malaria because it is not effective against exoerythrocytic forms of the parasites. Limitations of Use in Malaria: Do not use chloroquine phosphate tablets for the treatment of complicated malaria (high-grade parasitemia and/or complications e.g., cerebral malaria or acute renal failure). […]
FDA pharmacologic class: Antimalarial.
Source: FDA drug label (Chloroquine Phosphate), Rising Pharma Holdings, Inc., effective July 2, 2026 (SPL set 06c69e2b-211b-4746-9f3a-f86d36520570), via openFDA; the full label on DailyMed
Is there a generic for chloroquine (Aralen)?
The FDA approved the first generic chloroquine on December 11, 1974. 11 generic applications are approved; 5 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 chloroquine from 4 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1949 earliest approval on file
- 1974 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for chloroquine (Aralen)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $6.65 per Chloroquine ph 500 mg tablet, up 16% from $5.76 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.
- Chloroquine ph 500 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Chloroquine ph 250 mg tablet | Generic | $2.54 per tablet | $76.19 | -6% |
| Chloroquine ph 500 mg tablet | Generic | $6.65 per tablet | $199.62 | +16% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the chloroquine label say about other medicines?
The chloroquine label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 20 other medicines name chloroquine. 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 |
|---|---|---|
| Tamoxifen | warnings | Significant risk factors for retinal damage include daily doses of chloroquine phosphate greater than 2.3 mg/kg of actual body weight, durations of use greater than five years, subnormal glomerular filtration, use of some concomitant drug products such as tamoxifen citrate (see PRECAUTIONS ), and concurrent macular … |
Other labels that name chloroquine
Source: FDA drug label (Chloroquine Phosphate), Rising Pharma Holdings, Inc., effective July 2, 2026 (SPL set 06c69e2b-211b-4746-9f3a-f86d36520570), via openFDA; the full label on DailyMed
What do FAERS reports show for chloroquine?
The FDA Adverse Event Reporting System holds 654 reports that list chloroquine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 146 are coded as a death and 341 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 next?
- Other antimalarials
- the pharmacologic class, with prices and generics
- Chloroquine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other