NUZOLVENCE Oral suspension Ref.[116102] Active ingredients: Zoliflodacin

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

Product description

NUZOLVENCE for oral suspension contains zoliflodacin, an oral spiropyrimidinetrione bacterial type II topoisomerase inhibitor. The chemical name of zoliflodacin is (2R,4S,4aS)-11-Fluoro-1,2,4,4a-tetrahydro-2,4-dimethyl-8-[(4S)-4-methyl-2-oxo-3-oxazolidinyl]spiro[isoxazolo[4,5-g][1,4]oxazino[4,3-a]quinoline-5(6H),5′(2′H)-pyrimidine]-2′,4′,6′(1′H,3′H)-trione. Its molecular formula is C22H22FN5O7 and molecular mass is 487.4 g/mol. Its chemical structure is depicted below.

Each unit dose packet of NUZOLVENCE for oral suspension contains 3 g of zoliflodacin and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, talc, and xanthan gum.

Dosage Forms and Strengths

For Oral Suspension: 3 g of zoliflodacin as white to off-white granules in each unit-dose packet of NUZOLVENCE.

How Supplied

NUZOLVENCE (zoliflodacin) for oral suspension is supplied as a kit.

Table 6. NUZOLVENCE Kit Configuration:

Kit ConfigurationStrengthNDC Code
Carton containing:
• 1 unit-dose packet of white to off-white
granules containing zoliflodacin
• One 120 mL mixing container with lid
• Instructions for Use
• Medication Guide
3 g68547-915-10

Drugs

Drug Countries
NUZOLVENCE United States

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