0024-4512 : Fexinidazole 600 mg Oral Tablet

Labeler: Sanofi-aventis U.S. LLC
Product Type: Human Prescription Drug
Drug Name: Fexinidazole
Dosage Form: Oral Tablet
Application #: NDA214429
Rev. Date: 

NDC Package Codes:

  • 0024-4512-14: 14 TABLET IN 1 DOSE PACK (0024‑4512‑14)
  • 0024-4512-24: 24 TABLET IN 1 DOSE PACK (0024‑4512‑24)

Active Ingredients:

  • Fexinidazole

Dosage Strength:

  • 600 mg

Pharmaceutical Classes:

  • Nitroimidazole Antimicrobial [EPC]
  • Nitroimidazoles [CS]
  • Cytochrome P450 1A2 Inhibitors [MoA]
  • Cytochrome P450 2B6 Inhibitors [MoA]
  • Cytochrome P450 2C19 Inhibitors [MoA]
  • Cytochrome P450 2D6 Inhibitors [MoA]
  • Cytochrome P450 3A4 Inhibitors [MoA]
  • Cytochrome P450 3A5 Inhibitors [MoA]
  • Cytochrome P450 1A2 Inducers [MoA]
  • Cytochrome P450 2B6 Inducers [MoA]
  • Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]
  • Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]
  • Organic Cation Transporter 2 Inhibitors [MoA]
  • Organic Anion Transporter 1 Inhibitors [MoA]
  • Organic Anion Transporter 3 Inhibitors [MoA]
  • Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA]
  • Multidrug and Toxin Extrusion Transporter 2 K Inhibitors [MoA]


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