tiopronin
tiopronin is listed in the FDA National Drug Code directory with 9 NDC codes, marketed under brand names including Thiola, TIOPRONIN, Thiola EC. Available dosage forms: tablet, sugar coated, tablet, delayed release.
Drug Details
- Generic Name
- tiopronin
- Brand Names
- Thiola, TIOPRONIN, Thiola EC, VENXXIVA, tiopronin
- Application Number
- NDA019569
- Sponsor
- Mission Pharmacal Company
- NDC Codes
- 9
- Dosage Forms
- TABLET, SUGAR COATED, TABLET, DELAYED RELEASE
- Routes
- ORAL
- Active Ingredients
- TIOPRONIN
Indications and Usage
1 INDICATIONS AND USAGE Tiopronin delayed-release tablets are indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone. Additional pediatric use information is approved for Mission Pharmacal Company’s Thiola EC (tiopronin delayed-release) tablets. However, due to Mission Pharmacal Company’s marketing exclusivity rights, this drug product is not labeled with that information. Tiopronin delayed-release tablets are a reducing and complexing thiol indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone. ( 1 )