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  5. NDC Package Code: 55513-488-24 Lumakras

NDC Package 55513-488-24 Lumakras

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

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
55513-488-24
Package Description:
1 BOTTLE, PLASTIC in 1 CARTON / 240 TABLET, COATED in 1 BOTTLE, PLASTIC (55513-488-40)
Product Code:
55513-488
Proprietary Name:
Lumakras
Non-Proprietary Name:
Sotorasib
Substance Name:
Sotorasib
Usage Information:
LUMAKRAS is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test [see Dosage and Administration (2.1)], who have received at least one prior systemic therapy.This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR) [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
11-Digit NDC Billing Format:
55513048824
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: 2550719 - sotorasib 120 MG Oral Tablet
  • RxCUI: 2550725 - LUMAKRAS 120 MG Oral Tablet
  • RxCUI: 2550725 - sotorasib 120 MG Oral Tablet [Lumakras]
  • RxCUI: 2550725 - Lumakras 120 MG Oral Tablet
  • RxCUI: 2628240 - sotorasib 320 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Amgen Inc
    Dosage Form:
    Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • SOTORASIB 120 mg/1
    • Sample Package:
    No
    FDA Application Number:
    NDA214665
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    05-28-2021
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    55513-488-022 BOTTLE, PLASTIC in 1 CARTON / 120 TABLET, COATED in 1 BOTTLE, PLASTIC (55513-488-01)
    55513-488-961 BOTTLE, PLASTIC in 1 CARTON / 120 TABLET, COATED in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 55513-488-24?

    The NDC Packaged Code 55513-488-24 is assigned to a package of 1 bottle, plastic in 1 carton / 240 tablet, coated in 1 bottle, plastic (55513-488-40) of Lumakras, a human prescription drug labeled by Amgen Inc. The product's dosage form is tablet, 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 55513-488 included in the NDC Directory?

    Yes, Lumakras with product code 55513-488 is active and included in the NDC Directory. The product was first marketed by Amgen Inc on May 28, 2021 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 55513-488-24?

    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 55513-488-24?

    The 11-digit format is 55513048824. 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
    5-3-255513-488-245-4-255513-0488-24