Kombiglyze
NDC Package 0003-4222-91

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.

Kombiglyze is saxagliptin/metformin is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Marketed by E.r. Squibb & Sons, L.l.c., this product is identified by NDC 0003-4222 and is authorized under FDA application NDA200678.

Identification & Billing

NDC Package Code
0003-4222-91
Package Description
1 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
0003-4222
11-Digit Billing Format
00003422291

Clinical Specifications

Proprietary Name
Kombiglyze XR
Dosage Form
-
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.

Regulatory & Marketing

Labeler Name
E.r. Squibb & Sons, L.l.c.
FDA Application #
NDA200678
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-05-2010
End Marketing Date
05-31-2017
Listing Expiration
05-31-2017
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 (0003-4222). Click a package code to view its specific billing and regulatory data.

0003-4222-16
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
0003-4222-31
500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
0003-4222-90
2 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED, EXTENDED RELEASE 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 0003-4222-91 identifies a specific commercial package of 1 blister pack in 1 carton / 6 tablet, film coated, extended release in 1 blister pack of Kombiglyze XR, labeled by E.r. Squibb & Sons, L.l.c.. 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 E.r. Squibb & Sons, L.l.c. on November 05, 2010. The current certification is valid through May 31, 2017.

What are the primary indications for this medication?

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.

How is this E.r. Squibb & Sons, L.l.c. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00003422291. 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)
0003-4222-91
11-Digit CMS (5-4-2)
00003-4222-91

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