JESDUVROQ Film coated tablet Ref.[50977] Active ingredients: Daprodustat

Source: FDA, National Drug Code (US)  Revision Year: 2023 

Product description

JESDUVROQ contains daprodustat, an inhibitor of hypoxia inducible factor (HIF), prolyl 4-hydroxylases (PH)1, PH2 and PH3. The chemical name of daprodustat is N‑[(1,3‑dicyclohexylhexahydro-2,4,6-trioxopyrimidin-5-yl) carbonyl]glycine. The molecular formula of daprodustat is C19H27N3O6, and its molecular mass is 393.43. The structural formula is shown below.

Daprodustat is a white to off-white powder that is poorly soluble in water.

Each JESDUVROQ oral tablet contains 1 mg, 2 mg, 4 mg, 6 mg, or 8 mg of daprodustat. Inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, mannitol and microcrystalline cellulose. The tablet film-coating inactive ingredients include hypromellose, iron oxide black (1 mg, 2 mg, and 6 mg tablets), iron oxide red and iron oxide yellow (1 mg, 2 mg, 6 mg, and 8 mg tablets), polyethylene glycol, and titanium dioxide.

Dosage Forms and Strengths

Tablets:

  • 1 mg, gray, biconvex, round film-coated tablets debossed with “GS KF” on one face.
  • 2 mg, yellow, biconvex, round film-coated tablets debossed with “GS V7” on one face.
  • 4 mg, white, biconvex, round film-coated tablets debossed with “GS 13” on one face.
  • 6 mg, pink, biconvex, round film-coated tablets debossed with “GS IM” on one face.
  • 8 mg, orange, biconvex, round film-coated tablets debossed with “GS 5E” on one face.
How Supplied

JESDUVROQ tablets contain 1 mg, 2 mg, 4 mg, 6 mg or 8 mg of daprodustat.

Tablet
Strength		Package Configuration
and NDC Number		Tablet Description
and Markings
1 mg 30 count bottle
(NDC 0173-0897-13) 		Round, gray, biconvex, film-
coated tablets debossed with
“GS KF” on one side
2 mg 30 count bottle
(NDC 0173-0903-13) 		Round, yellow, biconvex, film-
coated tablets debossed with
“GS V7” on one side
4 mg 30 count bottle
(NDC 0173-0906-13) 		Round, white, biconvex, film-
coated tablets debossed with
“GS 13” on one side
6 mg 30 count bottle
(NDC 0173-0911-13) 		Round, pink, biconvex, film-
coated tablets debossed with
“GS IM” on one side
8 mg 30 count bottle
(NDC 0173-0914-13) 		Round, orange, biconvex, film-
coated tablets debossed with
“GS 5E” on one side

Manufactured by, GlaxoSmithKline, Durham, NC 27701

Drugs

Drug Countries
JESDUVROQ United States
 
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