Quick answers
- What is Pyrimethamine used for?
- The FDA-approved label (Daraprim, TILDE Sciences LLC, December 7, 2023) says: “Treatment of Toxoplasmosis: DARAPRIM is indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Pyrimethamine have a boxed warning?
- No. None of the 6 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Pyrimethamine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Pyrimethamine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Pyrimethamine?
- 6 companies list prescription products of Pyrimethamine in the FDA NDC Directory, including TILDE Sciences LLC, Vyera Pharmaceuticals, LLC and Aurobindo Pharma Limited.
What Pyrimethamine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Treatment of Toxoplasmosis: DARAPRIM is indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination.
— FDA label: Daraprim, TILDE Sciences LLC, effective December 7, 2023. Read the full label on DailyMed →
The FDA has 6 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 6 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 6 in the FDA NDC Directory |
| Brand names | Daraprim |
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 |
|---|---|---|
| pyrimethamine 25 mg tablet | Generic | $137.01 per tablet |
NADAC list of November 4, 2026; these prices took effect on May 20, 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.
- TILDE Sciences LLC1 product
- Vyera Pharmaceuticals, LLC1 product
- Aurobindo Pharma Limited1 product
- Oakrum Pharma, LLC1 product
- Teva Pharmaceuticals, Inc.1 product
- Dr.Reddys Laboratories Inc1 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 |
|---|---|---|---|
| NDA008578 DARAPRIM | Tilde Sciences | January 23, 1953 | 9, latest June 21, 2017 2017: Labeling · 2017: Labeling · 2003: Labeling |
Generic approvals (3)
- ANDA207127Pharmazone · February 28, 2020
- ANDA215506Teva Pharms · August 13, 2021
- ANDA216983Aurobindo Pharma Ltd · October 25, 2022
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) | 198182, 201912 |
|---|---|
| SPL set ID of the quoted label | f634f34b-0952-4dd3-9da3-f84b6ab823de |
| FDA labels (SPL) | 6 |
| FDA applications | NDA008578, 3 ANDA |
| Active ingredients (FDA) | PYRIMETHAMINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Daraprim, TILDE Sciences LLC, effective December 7, 2023; 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 →