What is NDC 0642-7464?

0642-7464 is the product NDC for Benznidazole, Benznidazole 100 mg/1 tablet, listed with the FDA by Exeltis USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Exeltis USA, Inc., NDC labeler code 0642. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Benznidazole?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Benznidazole NDC 0642-7464 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0642-7464Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00642-7464Add 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
0642-7464-10	0064274641000642746410	1 BOTTLE in 1 CARTON (0642-7464-10) / 100 TABLET in 1 BOTTLEMarketed from Mar 30, 2018

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): Benznidazole
Generic name (nonproprietary): benznidazole
Active ingredients: Benznidazole — 100 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Exeltis USA, Inc.NDC labeler code 0642
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 209570
Marketing start: Mar 30, 2018
Listing expires: Dec 31, 2027
Identifiers: Product ID 0642-7464_5a0a4918-baac-1b17-e063-6294a90a781bSPL ID 5a0a4918-baac-1b17-e063-6294a90a781bSPL set ID 8983d6a0-f63f-4f8e-bba4-38223f39e29bRxCUI 430551, 1993222UNII YC42NRJ1ZDUPC 0306427463122, 0306427464105

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

N400642746410 followed by a unit qualifier and the quantity

Package 00642-7464-10. 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 Aug 27, 2026.

Indications (excerpt from the label)

Benznidazole Tablets are indicated in pediatric patients 2 to 12 years of age for the treatment of Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi . This indication is approved under accelerated approval based on the number of treated patients who became Immunoglobulin G (IgG) antibody negative against the recombinant antigens of T. cruzi [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Benznidazole Tablets, a nitroimidazole antimicrobial, is indicated in pediatric patients 2 to 12 years of age for the treatment of Chagas disease (American trypanosomiasi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0642-7464

What is NDC 0642-7464?: 0642-7464 is the product NDC for Benznidazole, Benznidazole 100 mg/1 tablet, listed with the FDA by Exeltis USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Benznidazole.
What is the active ingredient?: Benznidazole.
Who is the labeler?: Exeltis USA, Inc., NDC labeler code 0642. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Benznidazole?: 1 other product NDC are listed under this name. See all Benznidazole NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Benznidazole NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Benznidazole	Benznidazole 12.5 mg/1	TabletOral	Exeltis USA, Inc.	0642-7463	00642-7463-12

Other NDCs under NDA 209570

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 209570
Product	Strength	Form · route	Labeler	Product NDC
Benznidazole	Benznidazole 12.5 mg/1	TabletOral	Exeltis USA, Inc.	0642-7463