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  5. NDC Package Code: 50419-750-01 Lampit

NDC Package 50419-750-01 Lampit

Nifurtimox Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
50419-750-01
Package Description:
1 BOTTLE in 1 CARTON / 100 TABLET, FILM COATED in 1 BOTTLE
Product Code:
50419-750
Proprietary Name:
Lampit
Non-Proprietary Name:
Nifurtimox
Substance Name:
Nifurtimox
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)].
11-Digit NDC Billing Format:
50419075001
NDC to RxNorm Crosswalk:
  • RxCUI: 2395842 - nifurtimox 30 MG Oral Tablet
  • RxCUI: 2397991 - Lampit 30 MG Oral Tablet
  • RxCUI: 2397991 - nifurtimox 30 MG Oral Tablet [Lampit]
  • RxCUI: 2397994 - Lampit 120 MG Oral Tablet
  • RxCUI: 2397994 - nifurtimox 120 MG Oral Tablet [Lampit]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Bayer Healthcare Pharmaceuticals Inc.
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • NIFURTIMOX 30 mg/1
    • Sample Package:
    No
    FDA Application Number:
    NDA213464
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    10-01-2020
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 50419-750-01?

    The NDC Packaged Code 50419-750-01 is assigned to a 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.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 50419-750 included in the NDC Directory?

    Yes, Lampit with product code 50419-750 is active and included in the NDC Directory. The product was first marketed by Bayer Healthcare Pharmaceuticals Inc. on October 01, 2020 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 50419-750-01?

    The 11-digit format is 50419075001. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-250419-750-015-4-250419-0750-01