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  5. NDC Package Code: 0078-1161-47 Mekinist

NDC Package 0078-1161-47 Mekinist

Trametinib Powder, For Solution 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:
0078-1161-47
Package Description:
90 mL in 1 BOTTLE
Product Code:
0078-1161
Proprietary Name:
Mekinist
Non-Proprietary Name:
Trametinib
Substance Name:
Trametinib Dimethyl Sulfoxide
Usage Information:
Trametinib may be used alone or in combination with another medication (dabrafenib) to treat a type of skin cancer (melanoma). It is also used with dabrafenib to treat thyroid cancer and a type of lung cancer (non-small cell lung cancer-NSCLC). Trametinib works by slowing the growth of cancer cells.
11-Digit NDC Billing Format:
00078116147
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
90 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 1425104 - trametinib 0.5 MG Oral Tablet
  • RxCUI: 1425104 - trametinib 0.5 MG (as trametinib dimethyl sulfoxide 0.5635 MG) Oral Tablet
  • RxCUI: 1425110 - Mekinist 0.5 MG Oral Tablet
  • RxCUI: 1425110 - trametinib 0.5 MG Oral Tablet [Mekinist]
  • RxCUI: 1425110 - Mekinist 0.5 MG (as trametinib dimethyl sulfoxide 0.5635 MG) Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Novartis Pharmaceuticals Corporation
    Dosage Form:
    Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • TRAMETINIB DIMETHYL SULFOXIDE .05 mg/mL
    • Pharmacologic Class(es):
  • Kinase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Protein Kinase Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA217513
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    03-16-2023
    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.

    Frequently Asked Questions

    What is NDC 0078-1161-47?

    The NDC Packaged Code 0078-1161-47 is assigned to a package of 90 ml in 1 bottle of Mekinist, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. The product's dosage form is powder, for solution and is administered via oral form.This product is billed per "ML" milliliter and contains an estimated amount of 90 billable units per package.

    Is NDC 0078-1161 included in the NDC Directory?

    Yes, Mekinist with product code 0078-1161 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, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0078-1161-47?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 90.

    What is the 11-digit format for NDC 0078-1161-47?

    The 11-digit format is 00078116147. 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
    4-4-20078-1161-475-4-200078-1161-47