Lampit Tablet, Film Coated
NDC Package 50419-751-01

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

Package Information

Lampit (nifurtimox) tablets is lAMPIT is indicated in pediatric patients (birth to less than 18 years of age and weighing at least 2.5 kg) for the treatment of Chagas disease (American Trypanosomiasis) caused by Trypanosoma cruzi. This formulation utilizes a tablet, film coated delivery system. Marketed by Bayer Healthcare Pharmaceuticals Inc., this product is identified by NDC 50419-751 and is authorized under FDA application NDA213464.

Identification & Billing

NDC Package Code
50419-751-01
Package Description
1 BOTTLE in 1 CARTON / 100 TABLET, FILM COATED in 1 BOTTLE
Product Code
50419-751
11-Digit Billing Format
50419075101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lampit
Non-Proprietary Name
Nifurtimox
Substance Name
Nifurtimox
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
NIFURTIMOX 120 mg/1
Usage Information
LAMPIT is indicated in pediatric patients (birth to less than 18 years of age and weighing at least 2.5 kg) 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 or who showed an at least 20% decrease in optical density on two different IgG antibody tests against antigens of T. cruzi. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s) [see Clinical Studies (14)].

Regulatory & Marketing

Labeler Name
Bayer Healthcare Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA213464
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-01-2020
Listing Expiration
12-31-2027
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 50419-751-01 identifies a specific commercial package of 1 bottle in 1 carton / 100 tablet, film coated in 1 bottle of Lampit, a human prescription drug labeled by Bayer Healthcare Pharmaceuticals Inc.. This tablet, film coated is formulated for oral use and contains nifurtimox 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 Bayer Healthcare Pharmaceuticals Inc. on October 01, 2020. The current certification is valid through December 31, 2027.

How is this Bayer Healthcare Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50419075101. 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 (5-3-2)
50419-751-01
11-Digit CMS (5-4-2)
50419-0751-01

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