What is NDC 0024-4512?

0024-4512 is the product NDC for Fexinidazole, Fexinidazole 600 mg/1 tablet, listed with the FDA by Sanofi-Aventis U.S. LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Sanofi-Aventis U.S. LLC, NDC labeler code 0024. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Fexinidazole?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Fexinidazole NDC 0024-4512 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0024-4512Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00024-4512Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0024-4512-14	00024451214	14 TABLET in 1 DOSE PACK (0024-4512-14)Marketed from Jul 16, 2021
0024-4512-24	00024451224	24 TABLET in 1 DOSE PACK (0024-4512-24)Marketed from Jul 16, 2021

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Fexinidazole
Generic name (nonproprietary): fexinidazole
Active ingredients: Fexinidazole — 600 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Sanofi-Aventis U.S. LLCNDC labeler code 0024
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 214429
Marketing start: Jul 16, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 1A2 Inducers (Mechanism)Cytochrome P450 1A2 Inhibitors (Mechanism)Cytochrome P450 2B6 Inducers (Mechanism)Cytochrome P450 2B6 Inhibitors (Mechanism)Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)Cytochrome P450 3A5 Inhibitors (Mechanism)Multidrug and Toxin Extrusion Transporter 1 Inhibitors (Mechanism)Multidrug and Toxin Extrusion Transporter 2 K Inhibitors (Mechanism)Nitroimidazoles (Chemical structure)Organic Anion Transporter 1 Inhibitors (Mechanism)Organic Anion Transporter 3 Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B1 Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B3 Inhibitors (Mechanism)Organic Cation Transporter 2 Inhibitors (Mechanism)
Identifiers: Product ID 0024-4512_1b3dbe65-328a-450b-bc3d-0b46d9acd832SPL ID 1b3dbe65-328a-450b-bc3d-0b46d9acd832SPL set ID 74a611bc-9977-46bb-b626-0370b3031628RxCUI 2564151, 2564152, 2564153UNII 306ERL82IR
Pharmacologic class: Nitroimidazole Antimicrobial

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400024451214 followed by a unit qualifier and the quantity

Package 00024-4512-14. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective May 2, 2025.

Indications (excerpt from the label)

Fexinidazole Tablets are indicated for the treatment of both the first-stage (hemolymphatic) and second-stage (meningoencephalitic) human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense in patients 6 years of age and older and weighing at least 20 kg. Fexinidazole Tablets is a nitroimidazole antimicrobial, indicated for the treatment of both first-stage (hemolymphatic) and second-stage (meningoencephalitic) human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense in patients 6 years of age and older and weighing at least 20 kg. ( 1 ) Limitations of Use Due to the decreased efficacy observed in patients with severe second stage HAT (cerebrospinal fluid white b…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0024-4512

What is NDC 0024-4512?: 0024-4512 is the product NDC for Fexinidazole, Fexinidazole 600 mg/1 tablet, listed with the FDA by Sanofi-Aventis U.S. LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Fexinidazole.
What is the active ingredient?: Fexinidazole.
Who is the labeler?: Sanofi-Aventis U.S. LLC, NDC labeler code 0024. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Fexinidazole?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.