Quick answers
- What is Chloroquine phosphate used for?
- The FDA-approved label (Chloroquine Phosphate, Rising Pharma Holdings, Inc., July 2, 2026) says: “Chloroquine 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Chloroquine phosphate have a boxed warning?
- No. None of the 4 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Chloroquine phosphate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Chloroquine phosphate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Chloroquine phosphate?
- 4 companies list prescription products of Chloroquine phosphate in the FDA NDC Directory, including Amneal Pharmaceuticals of New York LLC, Rising Pharma Holdings, Inc. and Chartwell RX, LLC.
What Chloroquine phosphate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Chloroquine 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. …
— FDA label: Chloroquine Phosphate, Rising Pharma Holdings, Inc., effective July 2, 2026. Read the full label on DailyMed →
The FDA has 4 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.
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 4 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Tablet, coated |
|---|---|
| Route | Oral |
| Prescription products | 6 in the FDA NDC Directory |
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 |
|---|---|---|
| chloroquine phosphate 250 mg tablet | Generic | $2.46 per tablet |
| chloroquine phosphate 500 mg tablet | Generic | $6.61 per tablet |
| chloroquine phosphate 500 mg tablet, coated | Generic | $6.61 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.
- Amneal Pharmaceuticals of New York LLC2 products
- Rising Pharma Holdings, Inc.2 products
- Chartwell RX, LLC1 product
- AvKARE1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (5)
- ANDA080880Impax Labs · December 11, 1974
- ANDA040516Impax Labs · August 29, 2003
- ANDA090612Natco Pharma Ltd · January 21, 2011
- ANDA091621Natco Pharma Ltd · January 21, 2011
- ANDA214756Cohance Lifesciences · September 3, 2021
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1116758, 1117531 |
|---|---|
| SPL set ID of the quoted label | 06c69e2b-211b-4746-9f3a-f86d36520570 |
| FDA labels (SPL) | 4 |
| FDA applications | 5 ANDA |
| Active ingredients (FDA) | CHLOROQUINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Chloroquine Phosphate, Rising Pharma Holdings, Inc., effective July 2, 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 →