Quick answers
- What is Propylthiouracil used for?
- The FDA-approved label (Propylthiouracil, American Health Packaging, August 27, 2026) says: “Propylthiouracil is indicated: in patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter who are intolerant of methimazole and for whom surgery or radioactive iodine therapy is not an appropriate treatment option to ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy in patients who are intolerant of methimazole” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Propylthiouracil have a boxed warning?
- Yes. The FDA label for Propylthiouracil has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Propylthiouracil?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Propylthiouracil been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Propylthiouracil?
- 7 companies list prescription products of Propylthiouracil in the FDA NDC Directory, including Bryant Ranch Prepack, Par Health USA, LLC and American Health Packaging.
What Propylthiouracil is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Propylthiouracil is indicated: in patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter who are intolerant of methimazole and for whom surgery or radioactive iodine therapy is not an appropriate treatment option to ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy in patients who are intolerant of methimazole
— FDA label: Propylthiouracil, American Health Packaging, effective August 27, 2026. Read the full label on DailyMed →
The FDA has 8 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.
This label has a boxed warning. Read it on the full label →
8 of 8 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 8 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 |
|---|---|---|
| propylthiouracil 50 mg tablet | Generic | $0.2695 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.
- Bryant Ranch Prepack2 products
- Par Health USA, LLC1 product
- American Health Packaging1 product
- Macleods Pharmaceuticals Limited1 product
- Chartwell RX, LLC1 product
- Quagen Pharmaceuticals LLC1 product
- Teva Pharmaceuticals, Inc.1 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 |
|---|---|---|---|
| NDA006188 PROPYLTHIOURACIL | Ph Health | July 28, 1947 | 17, latest September 19, 2018 2018: Labeling · 2016: Labeling · 2015: Labeling |
Generic approvals (4)
- ANDA080016Chartwell Molecular · July 24, 1970
- ANDA080154Quagen · July 23, 1971
- ANDA080172Actavis Elizabeth · January 9, 1973
- ANDA208867Macleods Pharms · May 10, 2023
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) | 198175 |
|---|---|
| SPL set ID of the quoted label | d819e532-09ac-434a-84a6-636c4204c7aa |
| FDA labels (SPL) | 8 |
| FDA applications | NDA006188, 4 ANDA |
| Active ingredients (FDA) | PROPYLTHIOURACIL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Propylthiouracil, American Health Packaging, effective August 27, 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 →