Quick answers
- What is Primaquine phosphate used for?
- The FDA-approved label (Primaquine Phosphate, Sanofi-Aventis U.S. LLC, February 11, 2026) says: “Primaquine phosphate Tablets are indicated for the radical cure (prevention of relapse) of vivax malaria.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Primaquine 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 Primaquine phosphate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Primaquine phosphate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Primaquine phosphate?
- 5 companies list prescription products of Primaquine phosphate in the FDA NDC Directory, including Unichem Pharmaceuticals (USA), Inc., PD-Rx Pharmaceuticals, Inc. and AvKARE.
What Primaquine phosphate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Primaquine phosphate Tablets are indicated for the radical cure (prevention of relapse) of vivax malaria.
— FDA label: Primaquine Phosphate, Sanofi-Aventis U.S. LLC, effective February 11, 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, film coated · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 5 in the FDA NDC Directory |
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.
- Unichem Pharmaceuticals (USA), Inc.1 product
- PD-Rx Pharmaceuticals, Inc.1 product
- AvKARE1 product
- Ingenus Pharmaceuticals, LLC1 product
- Sanofi-Aventis U.S. LLC1 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 |
|---|---|---|---|
| NDA008316 PRIMAQUINE | Sanofi Aventis Us | January 23, 1952 | 17, latest February 2, 2026 2026: Labeling · 2025: Labeling · 2017: Labeling |
Generic approvals (2)
- ANDA204476Unichem · February 25, 2014
- ANDA206043Ingenus Pharms LLC · June 23, 2016
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) | 904170 |
|---|---|
| SPL set ID of the quoted label | 1bfbf4ae-81b8-4160-a00d-6322aadd4b59 |
| FDA labels (SPL) | 4 |
| FDA applications | NDA008316, 2 ANDA |
| Active ingredients (FDA) | PRIMAQUINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Primaquine Phosphate, Sanofi-Aventis U.S. LLC, effective February 11, 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 →