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  5. NDC Package Code: 50268-477-15 Leflunomide

NDC Package 50268-477-15 Leflunomide

Tablet 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:
50268-477-15
Package Description:
50 BLISTER PACK in 1 BOX / 1 TABLET in 1 BLISTER PACK (50268-477-11)
Product Code:
50268-477
Proprietary Name:
Leflunomide
Non-Proprietary Name:
Leflunomide
Substance Name:
Leflunomide
Usage Information:
This medication is used to treat rheumatoid arthritis, a condition in which the body's defense system (immune system) fails to recognize the body as itself and attacks the healthy tissues around the joints. Leflunomide helps to reduce the joint damage/pain/swelling and helps you to move better. It works by weakening your immune system and decreasing swelling (inflammation).
11-Digit NDC Billing Format:
50268047715
NDC to RxNorm Crosswalk:
  • RxCUI: 205284 - leflunomide 10 MG Oral Tablet
  • RxCUI: 205285 - leflunomide 20 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Avpak
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • LEFLUNOMIDE 10 mg/1
    • Pharmacologic Class(es):
  • Antirheumatic Agent - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA077090
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-17-2020
    Listing Expiration Date:
    12-31-2025
    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 50268-477-15?

    The NDC Packaged Code 50268-477-15 is assigned to a package of 50 blister pack in 1 box / 1 tablet in 1 blister pack (50268-477-11) of Leflunomide, a human prescription drug labeled by Avpak. The product's dosage form is tablet and is administered via oral form.

    Is NDC 50268-477 included in the NDC Directory?

    Yes, Leflunomide with product code 50268-477 is active and included in the NDC Directory. The product was first marketed by Avpak on September 17, 2020 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 50268-477-15?

    The 11-digit format is 50268047715. 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
    5-3-250268-477-155-4-250268-0477-15