Qtern
NDC Package 0310-6780-30

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

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Qtern is a medication a combination of 2 drugs: dapagliflozin and saxagliptin. Marketed by Astrazeneca Pharmaceuticals Lp, this product is identified by NDC 0310-6780 and is authorized under FDA application NDA209091.

Identification & Billing

NDC Package Code
0310-6780-30
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
0310-6780
11-Digit Billing Format
00310678030
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA

Clinical Specifications

Proprietary Name
Qtern
Dosage Form
-
Usage Information
This medication is a combination of 2 drugs: dapagliflozin and saxagliptin. It is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Dapagliflozin works by increasing the removal of sugar by your kidneys. Saxagliptin works by increasing levels of natural substances called incretins. Incretins help to control blood sugar by increasing insulin release, especially after a meal. They also decrease the amount of sugar your liver makes.

Regulatory & Marketing

Labeler Name
Astrazeneca Pharmaceuticals Lp
FDA Application #
NDA209091
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-04-2017
End Marketing Date
12-31-2025
Listing Expiration
12-31-2025
Exclude Flag
D
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 (0310-6780). Click a package code to view its specific billing and regulatory data.

0310-6780-95
7 TABLET, FILM COATED in 1 BLISTER PACK

* 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 0310-6780-30 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Qtern, labeled by Astrazeneca Pharmaceuticals Lp. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Astrazeneca Pharmaceuticals Lp on December 04, 2017. The current certification is valid through December 31, 2025.

What are the primary indications for this medication?

This medication is a combination of 2 drugs: dapagliflozin and saxagliptin. It is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Dapagliflozin works by increasing the removal of sugar by your kidneys. Saxagliptin works by increasing levels of natural substances called incretins. Incretins help to control blood sugar by increasing insulin release, especially after a meal. They also decrease the amount of sugar your liver makes.

How is this Astrazeneca Pharmaceuticals Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00310678030. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
0310-6780-30
11-Digit CMS (5-4-2)
00310-6780-30

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