fexinidazole

Generic: fexinidazole

Labeler: sanofi-aventis u.s. llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name fexinidazole
Generic Name fexinidazole
Labeler sanofi-aventis u.s. llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fexinidazole 600 mg/1

Manufacturer
Sanofi-Aventis U.S. LLC

Identifiers & Regulatory

Product NDC 0024-4512
Product ID 0024-4512_1b3dbe65-328a-450b-bc3d-0b46d9acd832
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214429
Listing Expiration 2026-12-31
Marketing Start 2021-07-16

Pharmacologic Class

Established (EPC)
nitroimidazole antimicrobial [epc]
Mechanism of Action
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]
Chemical Structure
nitroimidazoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00244512
Hyphenated Format 0024-4512

Supplemental Identifiers

RxCUI
2564151 2564152 2564153
UNII
306ERL82IR
NUI
N0000175435 M0014907 N0000182138 N0000182139 N0000182140 N0000182137 N0000182141 N0000190115 N0000191266 N0000187064 N0000190107 N0000190108 N0000187061 N0000190110 N0000190111 N0000191423 N0000193932

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name fexinidazole (source: ndc)
Generic Name fexinidazole (source: ndc)
Application Number NDA214429 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 14 TABLET in 1 DOSE PACK (0024-4512-14)
  • 24 TABLET in 1 DOSE PACK (0024-4512-24)
source: ndc

Packages (2)

0024-4512-14 14 TABLET in 1 DOSE PACK (0024-4512-14) 0024-4512-24 24 TABLET in 1 DOSE PACK (0024-4512-24)

Ingredients (1)

fexinidazole (600 mg/1)

Linked Drug Pages (1)

Fexinidazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1b3dbe65-328a-450b-bc3d-0b46d9acd832", "openfda": {"nui": ["N0000175435", "M0014907", "N0000182138", "N0000182139", "N0000182140", "N0000182137", "N0000182141", "N0000190115", "N0000191266", "N0000187064", "N0000190107", "N0000190108", "N0000187061", "N0000190110", "N0000190111", "N0000191423", "N0000193932"], "unii": ["306ERL82IR"], "rxcui": ["2564151", "2564152", "2564153"], "spl_set_id": ["74a611bc-9977-46bb-b626-0370b3031628"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "pharm_class_moa": ["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]"], "manufacturer_name": ["Sanofi-Aventis U.S. LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 TABLET in 1 DOSE PACK (0024-4512-14)", "package_ndc": "0024-4512-14", "marketing_start_date": "20210716"}, {"sample": false, "description": "24 TABLET in 1 DOSE PACK (0024-4512-24)", "package_ndc": "0024-4512-24", "marketing_start_date": "20210716"}], "brand_name": "Fexinidazole", "product_id": "0024-4512_1b3dbe65-328a-450b-bc3d-0b46d9acd832", "dosage_form": "TABLET", "pharm_class": ["Cytochrome P450 1A2 Inducers [MoA]", "Cytochrome P450 1A2 Inhibitors [MoA]", "Cytochrome P450 2B6 Inducers [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]", "Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA]", "Multidrug and Toxin Extrusion Transporter 2 K Inhibitors [MoA]", "Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]", "Organic Anion Transporter 1 Inhibitors [MoA]", "Organic Anion Transporter 3 Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]", "Organic Cation Transporter 2 Inhibitors [MoA]"], "product_ndc": "0024-4512", "generic_name": "Fexinidazole", "labeler_name": "Sanofi-Aventis U.S. LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fexinidazole", "active_ingredients": [{"name": "FEXINIDAZOLE", "strength": "600 mg/1"}], "application_number": "NDA214429", "marketing_category": "NDA", "marketing_start_date": "20210716", "listing_expiration_date": "20261231"}