Lumakras Tablet, Coated
NDC Package 55513-488-96

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Lumakras (sotorasib) tablets is 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)]. This formulation utilizes a tablet, coated delivery system. Marketed by Amgen Inc, this product is identified by NDC 55513-488 and is authorized under FDA application NDA214665.

Identification & Billing

NDC Package Code
55513-488-96
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 120 TABLET, COATED in 1 BOTTLE, PLASTIC
Product Code
55513-488
11-Digit Billing Format
55513048896
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lumakras
Non-Proprietary Name
Sotorasib
Substance Name
Sotorasib
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SOTORASIB 120 mg/1
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).

Regulatory & Marketing

Labeler Name
Amgen Inc
Product Type
Human Prescription Drug
FDA Application #
NDA214665
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-28-2021
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
Yes

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (55513-488). Click a package code to view its specific billing and regulatory data.

55513-488-02
2 BOTTLE, PLASTIC in 1 CARTON / 120 TABLET, COATED in 1 BOTTLE, PLASTIC (55513-488-01)
55513-488-24
1 BOTTLE, PLASTIC in 1 CARTON / 240 TABLET, COATED in 1 BOTTLE, PLASTIC (55513-488-40)

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 55513-488-96 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 120 tablet, coated in 1 bottle, plastic of Lumakras, a human prescription drug labeled by Amgen Inc. This tablet, coated is formulated for oral use and contains sotorasib as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Amgen Inc on May 28, 2021. The current certification is valid through December 31, 2026.

How is this Amgen Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55513048896. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
55513-488-96
11-Digit CMS (5-4-2)
55513-0488-96

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.