NDC Package 0003-4223-90 Kombiglyze XR

View Billable Units, 11-Digit Format, RxNorm

Package Information

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

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:
0003-4223-90
Package Description:
1 BLISTER PACK in 1 CARTON / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Product Code:
Proprietary Name:
Kombiglyze XR
Usage Information:
Saxagliptin/metformin 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 product contains 2 medications: saxagliptin and metformin. 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. Metformin lowers blood sugar by helping to restore your body's proper response to the insulin. It also decreases the amount of sugar that your liver makes and that your stomach/intestines absorb.
11-Digit NDC Billing Format:
00003422390
Labeler Name:
E.r. Squibb & Sons, L.l.c.
Sample Package:
No
FDA Application Number:
NDA200678
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
11-05-2010
End Marketing Date:
03-31-2017
Listing Expiration Date:
03-31-2017
Exclude Flag:
D
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
0003-4223-1130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
0003-4223-2190 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
0003-4223-31500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0003-4223-90?

The NDC Packaged Code 0003-4223-90 is assigned to a package of 1 blister pack in 1 carton / 7 tablet, film coated, extended release in 1 blister pack of Kombiglyze XR, labeled by E.r. Squibb & Sons, L.l.c.. The product's dosage form is and is administered via form.

Is NDC 0003-4223 included in the NDC Directory?

No, Kombiglyze XR with product code 0003-4223 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by E.r. Squibb & Sons, L.l.c. on November 05, 2010 and its listing in the NDC Directory is set to expire on March 31, 2017 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 0003-4223-90?

The 11-digit format is 00003422390. 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
4-4-20003-4223-905-4-200003-4223-90