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
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 Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 306ERL82IR |
| Rxcui | 2564151, 2564152, 2564153 |
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 |
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 |