tiopronin
tiopronin is listed in the FDA National Drug Code directory with 8 NDC codes, marketed under brand names including TIOPRONIN, VENXXIVA, tiopronin. Available dosage forms: tablet, delayed release, tablet, sugar coated.
Drug Details
- Generic Name
- tiopronin
- Brand Names
- TIOPRONIN, VENXXIVA, tiopronin, Thiola EC, Thiola
- Application Number
- ANDA216990
- Sponsor
- Torrent Pharmaceuticals Limited
- NDC Codes
- 8
- Dosage Forms
- TABLET, DELAYED RELEASE, TABLET, SUGAR COATED
- 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 )