NDC Package 0310-6780-95 Qtern

Dapagliflozin And Saxagliptin Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

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:
0310-6780-95
Package Description:
7 TABLET, FILM COATED in 1 BLISTER PACK
Product Code:
Proprietary Name:
Qtern
Non-Proprietary Name:
Dapagliflozin And Saxagliptin
Substance Name:
Dapagliflozin; Saxagliptin Hydrochloride
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.
11-Digit NDC Billing Format:
00310678095
NDC to RxNorm Crosswalk:
  • RxCUI: 1925498 - dapagliflozin 10 MG / sAXagliptin 5 MG Oral Tablet
  • RxCUI: 1925498 - dapagliflozin 10 MG / saxagliptin 5 MG Oral Tablet
  • RxCUI: 1925498 - dapagliflozin 10 MG (as dapagliflozin propanediol 12.3 MG) / saxagliptin 5 MG (as saxagliptin HCl 5.95 MG) Oral Tablet
  • RxCUI: 1925504 - QTERN 10 MG / 5 MG Oral Tablet
  • RxCUI: 1925504 - dapagliflozin 10 MG / saxagliptin 5 MG Oral Tablet [Qtern]
Product Type:
Human Prescription Drug
Labeler Name:
Astrazeneca Pharmaceuticals Lp
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.
Sample Package:
No
FDA Application Number:
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
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.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
0310-6780-3030 TABLET, FILM COATED in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0310-6780-95?

The NDC Packaged Code 0310-6780-95 is assigned to a package of 7 tablet, film coated in 1 blister pack of Qtern, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. The product's dosage form is tablet, film coated and is administered via oral form.

Is NDC 0310-6780 included in the NDC Directory?

Yes, Qtern with product code 0310-6780 is active and included in the NDC Directory. The product was first marketed by Astrazeneca Pharmaceuticals Lp on December 04, 2017.

What is the 11-digit format for NDC 0310-6780-95?

The 11-digit format is 00310678095. 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
4-4-20310-6780-955-4-200310-6780-95