Xigduo Tablet, Film Coated, Extended Release
NDC Package 0310-6280-95

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

Xigduo (dapagliflozin and metformin hydrochloride) tablets is a medication a combination of 2 drugs: dapagliflozin and metformin. This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Astrazeneca Pharmaceuticals Lp, this product is identified by NDC 0310-6280 and is authorized under FDA application NDA205649.

Identification & Billing

NDC Package Code
0310-6280-95
Package Description
1 BLISTER PACK in 1 CARTON / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
0310-6280
11-Digit Billing Format
00310628095
RxNorm Crosswalk
  • RxCUI: 1593058 - dapagliflozin 10 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1593058 - 24 HR dapagliflozin 10 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet
  • RxCUI: 1593058 - dapagliflozin (as dapagliflozin propanediol) 10 MG / metformin hydrochloride 1000 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 1593068 - dapagliflozin 10 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1593068 - 24 HR dapagliflozin 10 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Xigduo XR
Non-Proprietary Name
Dapagliflozin And Metformin Hydrochloride
Substance Name
Dapagliflozin Propanediol; Metformin Hydrochloride
Dosage Form
Tablet, Film Coated, Extended Release - 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; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
This medication is a combination of 2 drugs: dapagliflozin and metformin. 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. This medication is also used in people with type 2 diabetes and heart disease to lower the risk of going to the hospital for heart failure. This medication works by helping to restore your body's proper response to the insulin you naturally produce. It also increases the removal of sugar by your kidneys, decreases how much sugar is made in your liver, and decreases how much sugar your body takes in through your stomach and intestines.

Regulatory & Marketing

Labeler Name
Astrazeneca Pharmaceuticals Lp
Product Type
Human Prescription Drug
FDA Application #
NDA205649
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-29-2014
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
Yes

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 (0310-6280). Click a package code to view its specific billing and regulatory data.

0310-6280-30
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

* 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 0310-6280-95 identifies a specific commercial package of 1 blister pack in 1 carton / 7 tablet, film coated, extended release in 1 blister pack of Xigduo XR, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. This tablet, film coated, extended release is formulated for oral use and contains dapagliflozin propanediol; metformin 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 Astrazeneca Pharmaceuticals Lp on October 29, 2014. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is a combination of 2 drugs: dapagliflozin and metformin. 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. This medication is also used in people with type 2 diabetes and heart disease to lower the risk of going to the hospital for heart failure. This medication works by helping to restore your body's proper response to the insulin you naturally produce. It also increases the removal of sugar by your kidneys, decreases how much sugar is made in your liver, and decreases how much sugar your body takes in through your stomach and intestines.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00310628095. 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)
0310-6280-95
11-Digit CMS (5-4-2)
00310-6280-95

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