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  5. NDC Package Code: 57962-007-12 Imbruvica

NDC Package 57962-007-12 Imbruvica

Ibrutinib Suspension 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:
57962-007-12
Package Description:
1 BOTTLE, GLASS in 1 CARTON / 108 mL in 1 BOTTLE, GLASS
Product Code:
57962-007
Proprietary Name:
Imbruvica
Non-Proprietary Name:
Ibrutinib
Substance Name:
Ibrutinib
Usage Information:
This medication is used to treat certain cancers (such as mantle cell or marginal zone lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldenstrom's macroglobulinemia). Ibrutinib belongs to a class of drugs known as kinase inhibitors. It works by slowing or stopping the growth of cancer cells. Ibrutinib is also used to treat a certain problem that may occur after a stem cell transplant (chronic graft versus host disease). It works by weakening your body's defense system (immune system).
11-Digit NDC Billing Format:
57962000712
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1442986 - ibrutinib 140 MG Oral Capsule
  • RxCUI: 1442992 - Imbruvica 140 MG Oral Capsule
  • RxCUI: 1442992 - ibrutinib 140 MG Oral Capsule [Imbruvica]
  • RxCUI: 1994360 - ibrutinib 70 MG Oral Capsule
  • RxCUI: 1994362 - Imbruvica 70 MG Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Pharmacyclics Llc
    Dosage Form:
    Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • IBRUTINIB 70 mg/mL
    • Pharmacologic Class(es):
  • Kinase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Protein Kinase Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA217003
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    08-24-2022
    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 57962-007-12?

    The NDC Packaged Code 57962-007-12 is assigned to a package of 1 bottle, glass in 1 carton / 108 ml in 1 bottle, glass of Imbruvica, a human prescription drug labeled by Pharmacyclics Llc. The product's dosage form is suspension and is administered via oral form.

    Is NDC 57962-007 included in the NDC Directory?

    Yes, Imbruvica with product code 57962-007 is active and included in the NDC Directory. The product was first marketed by Pharmacyclics Llc on August 24, 2022 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 57962-007-12?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 57962-007-12?

    The 11-digit format is 57962000712. 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
    5-3-257962-007-125-4-257962-0007-12