NDC 0024-4512

Fexinidazole

Fexinidazole

Fexinidazole is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Sanofi-aventis U.s. Llc. The primary component is Fexinidazole.

Product ID0024-4512_3debea6c-94ab-4eea-bd0e-5bf06b5b002a
NDC0024-4512
Product TypeHuman Prescription Drug
Proprietary NameFexinidazole
Generic NameFexinidazole
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2021-07-16
Marketing CategoryNDA /
Application NumberNDA214429
Labeler NameSanofi-Aventis U.S. LLC
Substance NameFEXINIDAZOLE
Active Ingredient Strength600 mg/1
Pharm ClassesNitroimidazole 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]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0024-4512-14

14 TABLET in 1 DOSE PACK (0024-4512-14)
Marketing Start Date2021-07-16
NDC Exclude FlagN
Sample Package?N

Drug Details


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