TRYVIO Film-coated tablet Ref.[108964] Active ingredients: Aprocitentan

Source: FDA, National Drug Code (US)  Revision Year: 2024 

Product description

TRYVIO (aprocitentan) is an ERA. The chemical name of aprocitentan is N-[5-(4-bromophenyl)6[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-sulfamide. It has a molecular formula of C16H14Br2N6O4S and a molecular weight of 546.2 g/mol.

The structural formula is:

Aprocitentan is a white to off-white powder that is insoluble in water.

TRYVIO is available as film-coated 12.5 mg strength tablets for oral administration. The inactive ingredients in TRYVIO are croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.

The film coating contains the following inactive ingredients: hydroxypropyl cellulose, iron oxide black, iron oxide red, iron oxide yellow, polyvinyl alcohol, silica colloidal hydrated, talc, titanium dioxide, and triethyl citrate.

Dosage Forms and Strengths

TRYVIO (aprocitentan) tablets are available as:

  • 12.5 mg: yellow to orange round, film-coated tablet, debossed with “AN” on one side and plain on the other side.
How Supplied

TRYVIO tablets are available as:

12.5 mg: yellow to orange round, film-coated tablet, debossed with “AN” on one side and plain on the other side.

  • NDC 80491-125-10, each blister contains 10 tablets
  • NDC 80491-125-30, each bottle contains 30 tablets and has a child-resistant closure

Distributed by: Idorsia Pharmaceuticals US Inc., One Radnor Corporate Center, Suite 101, 100 Matsonford Rd., Radnor, PA 19087

Drugs

Drug Countries
TRYVIO United States

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