NDC Package 0078-0709-56 Tabrecta

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

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:
0078-0709-56
Package Description:
56 TABLET, FILM COATED in 1 BOTTLE
Product Code:
Proprietary Name:
Tabrecta
Non-Proprietary Name:
Capmatinib
Substance Name:
Capmatinib Hydrochloride
Usage Information:
TABRECTA is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
11-Digit NDC Billing Format:
00078070956
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
56 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 2362234 - capmatinib 150 MG Oral Tablet
  • RxCUI: 2362234 - capmatinib 150 MG (capmatinib HCl 176.55 MG) Oral Tablet
  • RxCUI: 2362240 - TABRECTA 150 MG Oral Tablet
  • RxCUI: 2362240 - capmatinib 150 MG Oral Tablet [Tabrecta]
  • RxCUI: 2362240 - Tabrecta 150 MG (as capmatinib HCl 176.55 MG) Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Novartis Pharmaceuticals Corporation
    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):
    Sample Package:
    No
    FDA Application Number:
    NDA213591
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    05-06-2020
    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
    0078-0709-9456 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0078-0709-56?

    The NDC Packaged Code 0078-0709-56 is assigned to a package of 56 tablet, film coated in 1 bottle of Tabrecta, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. 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 56 billable units per package.

    Is NDC 0078-0709 included in the NDC Directory?

    Yes, Tabrecta with product code 0078-0709 is active and included in the NDC Directory. The product was first marketed by Novartis Pharmaceuticals Corporation on May 06, 2020 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 0078-0709-56?

    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 56.

    What is the 11-digit format for NDC 0078-0709-56?

    The 11-digit format is 00078070956. 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 4-4-2 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
    4-4-20078-0709-565-4-200078-0709-56