REZDIFFRA Tablet Ref.[108866] Active ingredients: Resmetirom

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

Product description

REZDIFFRA (resmetirom) tablets contain resmetirom, a thyroid hormone receptor-beta agonist. The chemical name for REZDIFFRA is 2-[3,5-Dichloro-4-((6-oxo-5-(propan-2-yl)-1,6-dihydropyridazin-3-yl)oxy)phenyl]-3,5-dioxo-2,3,4,5-tetrahydro-1,2,4-triazine-6-carbonitrile. The molecular formula is C17H12Cl2N6O4 and the molecular weight is 435.22. The chemical structure is:

Resmetirom has low aqueous solubility below pH 6 and higher solubility above pH 7 (0.44 mg/mL at pH 7.04).

REZDIFFRA tablets are supplied in 60 mg, 80 mg, and 100 mg strengths for oral administration. Each tablet contains the active ingredient, resmetirom, and the following USP/NF excipients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, and microcrystalline cellulose. REZDIFFRA tablets are film-coated with an Opadry coating comprised of polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, red iron oxide (100 mg tablets), yellow iron oxide (80 mg and 100 mg tablets).

Dosage Forms and Strengths

REZDIFFRA Tablets:

  • 60 mg: white oval-shaped film-coated tablets debossed with “P60” on one side and plain on the other side.
  • 80 mg: yellow, oval-shaped, film-coated tablets debossed with “P80” on one side and plain on the other side.
  • 100 mg: beige to pink, oval-shaped, film-coated tablets debossed with “P100” on one side and plain on the other side.
How Supplied

REZDIFFRA (resmetirom) tablets are packaged in white high-density polyethylene bottles closed witha child-resistant closure containing an induction seal.

60 mg Tablets: white oval-shaped film-coated tablets, debossed “P60” on one side and plain on theother side.

  • NDC 82576-060-30 60 mg tablets (30 count)

80 mg Tablets: yellow, oval-shaped, film-coated tablets, debossed with “P80” on one side and plainon the other side.

  • Bottle of 30 count (NDC 82576-080-30)
  • Bottle of 90 count (NDC 82576-080-90)

100 mg Tablets: beige to pink, oval-shaped, film-coated tablets, debossed with"P100" on one side and plain on the other side.

  • Bottle of 30 count (NDC 82576-100-30)
  • Bottle of 90 count (NDC 82576-100-90)

Manufactured by: UPM Pharmaceuticals (Bristol, TN)

Manufactured for: Madrigal Pharmaceuticals, West Conshohocken, PA

Drugs

Drug Countries
REZDIFFRA United States
 
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