Home NDC 0024-4512 Fexinidazole
Product NDC 0024-4512
11-digit product format 000244512
Labeler code 0024
Product ID 0024-4512_1b3dbe65-328a-450b-bc3d-0b46d9acd832
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fexinidazole
Dosage form TABLET
Route ORAL
Labeler Sanofi-Aventis U.S. LLC
Application NDA214429
Marketing category NDA
Marketing start 2021-07-16
Substance FEXINIDAZOLE
Active strength 600 mg/1
Pharmacologic classes 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]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N214429-001 FEXINIDAZOLE FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N214429-001 NCE 2026-07-16 N214429-001 ODE-359 2028-07-16
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214429-001 FEXINIDAZOLE 600MG TABLET / ORAL RLD, RS 2021-07-16 a50c72e98297…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 66 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Fexinidazole
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FEXINIDAZOLE 600 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 306ERL82IR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2564151 Internal RxNorm lookup 2564152 Internal RxNorm lookup 2564153 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0024-4512-14 Fexinidazole 14 in 1 DOSE PACK TABLET 14 10 0024-4512-24 Fexinidazole 24 in 1 DOSE PACK TABLET 24 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0024-4512 FEXINIDAZOLE TABLET [SANOFI-AVENTIS U.S. LLC] 10 Current NDC, Legacy NDC, 2 package rows 20250507_74a611bc-9977-46bb-b626-0370b3031628.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0024-4512-14 00024451214 14 TABLET in 1 DOSE PACK (0024-4512-14) 14 tablet 2021-07-16 0000-00-00 No No Current 0024-4512-24 00024451224 24 TABLET in 1 DOSE PACK (0024-4512-24) 24 tablet 2021-07-16 0000-00-00 No No Current