Quick answers
- What is Tiopronin used for?
- The FDA-approved label (Thiola, Mission Pharmacal Company, August 27, 2026) says: “THIOLA is indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 20 kg and greater with severe homozygous cystinuria, who are not responsive to these measures alone. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Tiopronin have a boxed warning?
- No. None of the 10 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Tiopronin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Tiopronin been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Tiopronin?
- 8 companies list prescription products of Tiopronin in the FDA NDC Directory, including Mission Pharmacal Company, BioComp Pharma, Inc. and Teva Pharmaceuticals, Inc..
What Tiopronin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
THIOLA is indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 20 kg and greater with severe homozygous cystinuria, who are not responsive to these measures alone. …
— FDA label: Thiola, Mission Pharmacal Company, effective August 27, 2026. Read the full label on DailyMed →
The FDA has 10 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 10 FDA labels for this medicine have a boxed warning.
Forms and how it is given
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.
- Mission Pharmacal Company3 products
- BioComp Pharma, Inc.3 products
- Teva Pharmaceuticals, Inc.2 products
- Par Health USA, LLC2 products
- Cycle Pharmaceuticals Ltd2 products
- Torrent Pharmaceuticals Limited2 products
- Teva Pharmaceuticals USA, Inc.1 product
- Amneal Pharmaceuticals NY 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 |
|---|---|---|---|
| NDA019569 THIOLA | Mission Pharma | August 11, 1988 | 3, latest June 28, 2019 2019: Labeling · 2001: Manufacturing (CMC) · 2000: Manufacturing (CMC) |
| NDA211843 THIOLA EC | Mission Pharmacal | June 28, 2019 | 1, latest March 8, 2021 2021: Labeling |
Generic approvals (5)
- ANDA214326Teva Pharms USA Inc · April 26, 2021
- ANDA217219Ph Health · February 24, 2023
- ANDA216278Amneal · August 15, 2023
- ANDA216990Torrent · January 30, 2024
- ANDA216456Teva Pharms Inc · July 22, 2024
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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Thiola, Mission Pharmacal Company, 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 →