Tiopronindrug info
tiopronin 100 MG Delayed Release Oral Tablet
What it is used for
VENXXIVA is 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. VENXXIVA is 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.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective December 22, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
VENXXIVA (tiopronin) delayed-release tablets are a reducing and cystine-binding thiol drug (CBTD) for oral use. Tiopronin is N‑(2‑Mercaptopropionyl) glycine and has the following structure: Tiopronin has the empirical formula C 5 H 9 NO 3 S and a molecular weight of 163.19. In this drug product tiopronin exists as a dl racemic mixture. Tiopronin is a white to off-white color crystalline powder, which is freely soluble in water. Each VENXXIVA tablet contains 100 or 300 mg of tiopronin. The inactive ingredients in VENXXIVA tablets include lactose monohydrate, low substitute hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, hypromellose 2910, methacrylic acid: ethyl acrylate copolymer (Eudragit L 100-55), talc, triethyl citrate. The imprinting ink contains shellac, ferrosoferric oxide and propylene glycol. image description
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective December 22, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
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