BLUJEPA Film-coated tablet Ref.[115538] Active ingredients: Gepotidacin

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

Product description

BLUJEPA tablets contain gepotidacin mesylate, a triazaacenaphthylene antibacterial that inhibits bacterial DNA gyrase and topoisomerase IV. The chemical name is (R)-2-((4-(((3,4-dihydro-2Hpyrano[2,3c]pyridin-6-yl)methyl)amino)piperidin-1-yl)methyl)-1,2-dihydro-3H,8H-2a,5,8a-triazaacenaphthylene-3,8-dione methanesulfonate dihydrate. The molecular formula is C24H28N6O3●CH4O3S●2H2O and its molecular mass is 580.66. The structural formula is shown below.

* stereogenic center

Each BLUJEPA oral tablet contains gepotidacin 750 mg (equivalent to 910.7 mg of gepotidacin mesylate [anhydrous]). Inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide.

Dosage Forms and Strengths

Each film coated tablet of BLUJEPA contains 750 mg of gepotidacin. BLUJEPA tablets are yellow, capsule shaped, and debossed with "GS GU3" on one side and plain on the other side.

How Supplied

BLUJEPA tablets are supplied as yellow, film-coated, capsule-shaped tablets debossed with "GS GU3" on one side and plain on the other side, containing 750 mg of gepotidacin.

Bottle of 20 tablets (NDC 0173-0922-45).

Manufactured for: GlaxoSmithKline, Durham, NC 27701

Drugs

Drug Countries
BLUJEPA United States

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