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  5. NDC Package Code: 80739-812-12 Krazati

NDC Package 80739-812-12 Krazati

Adagrasib 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:
80739-812-12
Package Description:
1 BOTTLE in 1 CARTON / 120 TABLET, COATED in 1 BOTTLE
Product Code:
80739-812
Proprietary Name:
Krazati
Non-Proprietary Name:
Adagrasib
Substance Name:
Adagrasib
Usage Information:
KRAZATI 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 objective 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 a clinical benefit in a confirmatory trial(s).
11-Digit NDC Billing Format:
80739081212
NDC to RxNorm Crosswalk:
  • RxCUI: 2625917 - adagrasib 200 MG Oral Tablet
  • RxCUI: 2625923 - KRAZATI 200 MG Oral Tablet
  • RxCUI: 2625923 - adagrasib 200 MG Oral Tablet [Krazati]
  • RxCUI: 2625923 - Krazati 200 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Mirati Therapeutics, 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):
  • ADAGRASIB 200 mg/1
    • Sample Package:
    No
    FDA Application Number:
    NDA216340
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    12-12-2022
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    80739-812-181 BOTTLE in 1 CARTON / 180 TABLET, COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 80739-812-12?

    The NDC Packaged Code 80739-812-12 is assigned to a package of 1 bottle in 1 carton / 120 tablet, coated in 1 bottle of Krazati, a human prescription drug labeled by Mirati Therapeutics, Inc. The product's dosage form is tablet, coated and is administered via oral form.

    Is NDC 80739-812 included in the NDC Directory?

    Yes, Krazati with product code 80739-812 is active and included in the NDC Directory. The product was first marketed by Mirati Therapeutics, Inc on December 12, 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 11-digit format for NDC 80739-812-12?

    The 11-digit format is 80739081212. 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
    5-3-280739-812-125-4-280739-0812-12