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  5. NDC Package Code: 78206-162-01 Renflexis

NDC Package 78206-162-01 Renflexis

Infliximab Injection, Powder, Lyophilized, For Solution Intravenous - 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:
78206-162-01
Package Description:
1 VIAL in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (78206-162-99)
Product Code:
78206-162
Proprietary Name:
Renflexis
Non-Proprietary Name:
Infliximab
Substance Name:
Infliximab
Usage Information:
This medication is used to treat certain types of arthritis (rheumatoid arthritis, arthritis of the spine, psoriatic arthritis), certain bowel diseases (Crohn's disease, ulcerative colitis), and a certain severe skin disease (chronic plaque psoriasis). In these conditions, the body's defense system (immune system) attacks healthy tissues. Infliximab works by blocking the actions of a certain natural substance (tumor necrosis factor alpha) in the body. This helps to decrease swelling (inflammation) and weaken your immune system, which slows or stops the damage from the disease. This monograph is about the following infliximab products: infliximab, infliximab-abda, infliximab-axxq, and infliximab-dyyb.
11-Digit NDC Billing Format:
78206016201
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1927285 - inFLIXimab-abda 100 MG Injection
  • RxCUI: 1927285 - infliximab-abda 100 MG Injection
  • RxCUI: 1927290 - RENFLEXIS 100 MG Injection
  • RxCUI: 1927290 - infliximab-abda 100 MG Injection [Renflexis]
  • RxCUI: 1927290 - Renflexis 100 MG Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Organon Llc
    Dosage Form:
    Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • INFLIXIMAB 100 mg/1
    • Pharmacologic Class(es):
  • Tumor Necrosis Factor Blocker - [EPC] (Established Pharmacologic Class)
  • Tumor Necrosis Factor Receptor Blocking Activity - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    BLA761054
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    04-21-2017
    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 78206-162-01?

    The NDC Packaged Code 78206-162-01 is assigned to a package of 1 vial in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial (78206-162-99) of Renflexis, a human prescription drug labeled by Organon Llc. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 78206-162 included in the NDC Directory?

    Yes, Renflexis with product code 78206-162 is active and included in the NDC Directory. The product was first marketed by Organon Llc on April 21, 2017 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 NDC billing unit for package 78206-162-01?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 78206-162-01?

    The 11-digit format is 78206016201. 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
    5-3-278206-162-015-4-278206-0162-01