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  5. NDC Package Code: 0078-1154-21 Tafinlar

NDC Package 0078-1154-21 Tafinlar

Dabrafenib Tablet, For 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:
0078-1154-21
Package Description:
210 TABLET, FOR SUSPENSION in 1 BOTTLE
Product Code:
0078-1154
Proprietary Name:
Tafinlar
Non-Proprietary Name:
Dabrafenib
Substance Name:
Dabrafenib Mesylate
Usage Information:
Dabrafenib may be used alone or in combination with another medication (trametinib) to treat a type of skin cancer (melanoma). It is also used with trametinib to treat thyroid cancer and a type of lung cancer (non-small cell lung cancer-NSCLC). Dabrafenib works by slowing the growth of cancer cells.
11-Digit NDC Billing Format:
00078115421
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
210 EA
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Novartis Pharmaceuticals Corporation
Dosage Form:
Tablet, For Suspension - A tablet that forms a suspension when placed in a liquid (formerly referred to as a ‘dispersible tablet’).
Administration Route(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
DABRAFENIB MESYLATE 10 mg/1
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
NDA217514
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
03-16-2023
Listing Expiration Date:
12-31-2026
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 0078-1154-21?

The NDC Packaged Code 0078-1154-21 is assigned to a package of 210 tablet, for suspension in 1 bottle of Tafinlar, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. The product's dosage form is tablet, for suspension and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 210 billable units per package.

Is NDC 0078-1154 included in the NDC Directory?

Yes, Tafinlar with product code 0078-1154 is active and included in the NDC Directory. The product was first marketed by Novartis Pharmaceuticals Corporation on March 16, 2023 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0078-1154-21?

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 210.

What is the 11-digit format for NDC 0078-1154-21?

The 11-digit format is 00078115421. 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
4-4-20078-1154-215-4-200078-1154-21