VANRAFIA Film-coated tablet Ref.[115500] Active ingredients: Atrasentan

Source: FDA, National Drug Code (US) Revision Year: 2025

Product description

VANRAFIA contains atrasentan, an endothelin type A (ET_A) receptor antagonist. The chemical name of atrasentan hydrochloride is (2R, 3R, 4S)-4-(1,3-benzodioxol-5-yl)-1-[2-(dibutylamino)-2-oxoethyl]-2-(4-methoxyphenyl)-3-pyrrolidinecarboxylic acid hydrochloride. Atrasentan hydrochloride has a molecular weight of 547.09 g/mol, a molecular formula of C₂₉H₃₈N₂O₆HCl and the following structural formula.

Atrasentan is a slightly hygroscopic white to off-white powder that is slightly soluble in water.

VANRAFIA is available as a film-coated tablet for oral administration. Each VANRAFIA tablet contains 0.75 mg atrasentan (equivalent to 0.803 mg of atrasentan hydrochloride) and contains the following excipients: crospovidone, glyceryl dibehenate, hypromellose, lactose monohydrate, L-cysteine hydrochloride monohydrate, polyethylene glycol, and silicon dioxide.

Dosage Forms and Strengths
VANRAFIA 0.75 mg: film-coated, round, biconvex, white to off-white tablet debossed with "7" on one side and unmarked on the other side.

How Supplied
VANRAFIA is supplied as follows: 0.75 mg tablets are film-coated, round, biconvex, white to off-white tablets debossed with "7" on one side and unmarked on the other side, packaged in a high-density polyethylene (HDPE) bottle containing a desiccant, with induction seal and child-resistant cap. Each bottle contains 30 tablets (NDC 0078-1420-15). Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936

How Supplied

VANRAFIA is supplied as follows:

0.75 mg tablets are film-coated, round, biconvex, white to off-white tablets debossed with "7" on one side and unmarked on the other side, packaged in a high-density polyethylene (HDPE) bottle containing a desiccant, with induction seal and child-resistant cap. Each bottle contains 30 tablets (NDC 0078-1420-15).

Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936

Drugs

Drug	Countries
VANRAFIA	United States

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