Mekinist Powder, For Solution
NDC Package 0078-1161-47

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

Package Information

Mekinist (trametinib) powders is trametinib may be used alone or in combination with another medication (dabrafenib) to treat a type of skin cancer (melanoma). This formulation utilizes a powder, for solution delivery system. Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-1161 and is authorized under FDA application NDA217513.

Identification & Billing

NDC Package Code
0078-1161-47
Package Description
90 mL in 1 BOTTLE
Product Code
0078-1161
11-Digit Billing Format
00078116147
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
90 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Mekinist
Non-Proprietary Name
Trametinib
Substance Name
Trametinib Dimethyl Sulfoxide
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TRAMETINIB DIMETHYL SULFOXIDE .05 mg/mL
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Novartis Pharmaceuticals Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA217513
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-16-2023
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0078-1161-47 identifies a specific commercial package of 90 ml in 1 bottle of Mekinist, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. This product is billed per "ML" milliliter and contains an estimated amount of 90 billable units per package. This powder, for solution is formulated for oral use and contains trametinib dimethyl sulfoxide 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 Novartis Pharmaceuticals Corporation on March 16, 2023. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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.

How is this Novartis Pharmaceuticals Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078116147. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 90 total billable units per package. 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 (4-4-2)
0078-1161-47
11-Digit CMS (5-4-2)
00078-1161-47

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