NDC Package 0078-1098-94 Scemblix

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

Package Information
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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:

0078-1098-94

Package Description:

14 TABLET, FILM COATED in 1 BOTTLE

Product Code:

0078-1098

Proprietary Name:

Scemblix

Non-Proprietary Name:

Asciminib

Substance Name:

Asciminib Hydrochloride

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.

11-Digit NDC Billing Format:

00078109894

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):

ASCIMINIB HYDROCHLORIDE 40 mg/1

Sample Package:

Yes

FDA Application Number:

NDA215358

Marketing Category:

NDA - A product marketed under an approved New Drug Application.

Start Marketing Date:

10-29-2021

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

0078 - Novartis Pharmaceuticals Corporation
- 0078-1098 - Scemblix
  - 0078-1098-94 - 14 TABLET, FILM COATED in 1 BOTTLE

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.

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Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
0078-1098-20	60 TABLET, FILM COATED in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0078-1098-94?

The NDC Packaged Code 0078-1098-94 is assigned to a package of 14 tablet, film coated in 1 bottle of Scemblix, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. The product's dosage form is tablet, film coated and is administered via oral form.

Is NDC 0078-1098 included in the NDC Directory?

Yes, Scemblix with product code 0078-1098 is active and included in the NDC Directory. The product was first marketed by Novartis Pharmaceuticals Corporation on October 29, 2021 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 0078-1098-94?

The 11-digit format is 00078109894. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
4-4-2	0078-1098-94	5-4-2	00078-1098-94

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