Scemblix Tablet, Film Coated
NDC Package 0078-1091-20

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

Package Information

Scemblix (asciminib) tablets is sCEMBLIX is indicated for the treatment of adult patients with:Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs).This indication is approved under accelerated approval based on major molecular response (MMR) [see Clinical Studies (14.1)]. This formulation utilizes a tablet, film coated delivery system. Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-1091 and is authorized under FDA application NDA215358.

Identification & Billing

NDC Package Code
0078-1091-20
Package Description
60 TABLET, FILM COATED in 1 BOTTLE
Product Code
0078-1091
11-Digit Billing Format
00078109120
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Scemblix
Non-Proprietary Name
Asciminib
Substance Name
Asciminib Hydrochloride
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ASCIMINIB HYDROCHLORIDE 20 mg/1
Usage Information
SCEMBLIX is indicated for the treatment of adult patients with:Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs).This indication is approved under accelerated approval based on major molecular response (MMR) [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).Ph+ CML in CP with the T315I mutation.

Regulatory & Marketing

Labeler Name
Novartis Pharmaceuticals Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA215358
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-29-2021
Listing Expiration
12-31-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0078-1091). Click a package code to view its specific billing and regulatory data.

0078-1091-94
14 TABLET, FILM COATED in 1 BOTTLE

* 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 0078-1091-20 identifies a specific commercial package of 60 tablet, film coated in 1 bottle of Scemblix, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. This tablet, film coated is formulated for oral use and contains asciminib hydrochloride 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 October 29, 2021. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078109120. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
0078-1091-20
11-Digit CMS (5-4-2)
00078-1091-20

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