Benznidazole Tablet
NDC Package 0642-7464-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Benznidazole tablets is benznidazole is an antibiotic that is used to treat a certain parasitic infection (Chagas disease). This formulation utilizes a tablet delivery system. Marketed by Exeltis Usa, Inc., this product is identified by NDC 0642-7464 and is authorized under FDA application NDA209570.

Identification & Billing

NDC Package Code
0642-7464-10
Package Description
1 BOTTLE in 1 CARTON / 100 TABLET in 1 BOTTLE
Product Code
0642-7464
11-Digit Billing Format
00642746410
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Benznidazole
Non-Proprietary Name
Benznidazole
Substance Name
Benznidazole
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
BENZNIDAZOLE 100 mg/1
Usage Information
Benznidazole is an antibiotic that is used to treat a certain parasitic infection (Chagas disease). It works by stopping the growth of a certain parasite. This antibiotic treats only Chagas disease. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

Regulatory & Marketing

Labeler Name
Exeltis Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA209570
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-30-2018
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0642-7464-10 identifies a specific commercial package of 1 bottle in 1 carton / 100 tablet in 1 bottle of Benznidazole, a human prescription drug labeled by Exeltis Usa, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This tablet is formulated for oral use and contains benznidazole as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Exeltis Usa, Inc. on March 30, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Benznidazole is an antibiotic that is used to treat a certain parasitic infection (Chagas disease). It works by stopping the growth of a certain parasite. This antibiotic treats only Chagas disease. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

How is this Exeltis Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00642746410. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0642-7464-10
11-Digit CMS (5-4-2)
00642-7464-10

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.