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  5. NDC Package Code: 71274-170-60 Joenja

NDC Package 71274-170-60 Joenja

Leniolisib 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:
71274-170-60
Package Description:
1 BOTTLE, PLASTIC in 1 CARTON / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code:
71274-170
Proprietary Name:
Joenja
Non-Proprietary Name:
Leniolisib
Substance Name:
Leniolisib Phosphate
Usage Information:
JOENJA is indicated for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older.
11-Digit NDC Billing Format:
71274017060
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: 2633015 - leniolisib 70 MG Oral Tablet
  • RxCUI: 2633015 - leniolisib 70 MG (equivalent to leniolisib phosphate 85.26 MG) Oral Tablet
  • RxCUI: 2633021 - Joenja 70 MG Oral Tablet
  • RxCUI: 2633021 - leniolisib 70 MG Oral Tablet [Joenja]
  • RxCUI: 2633021 - Joenja 70 MG (equivalent to leniolisib phosphate 85.26 MG) Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Pharming Healthcare 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):
  • LENIOLISIB PHOSPHATE 70 mg/1
    • Pharmacologic Class(es):
  • Breast Cancer Resistance Protein Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 1A2 Inhibitors - [MoA] (Mechanism of Action)
  • Kinase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Organic Anion Transporting Polypeptide 1B1 Inhibitors - [MoA] (Mechanism of Action)
  • Organic Anion Transporting Polypeptide 1B3 Inhibitors - [MoA] (Mechanism of Action)
  • Phosphoinositide 3-Kinase delta Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA217759
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    03-29-2023
    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 71274-170-60?

    The NDC Packaged Code 71274-170-60 is assigned to a package of 1 bottle, plastic in 1 carton / 60 tablet, film coated in 1 bottle, plastic of Joenja, a human prescription drug labeled by Pharming Healthcare Inc.. The product's dosage form is tablet, film coated and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 71274-170 included in the NDC Directory?

    Yes, Joenja with product code 71274-170 is active and included in the NDC Directory. The product was first marketed by Pharming Healthcare Inc. on March 29, 2023 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 NDC billing unit for package 71274-170-60?

    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 71274-170-60?

    The 11-digit format is 71274017060. 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
    5-3-271274-170-605-4-271274-0170-60