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  5. NDC Package Code: 0310-6145-30 Kombiglyze XR

NDC Package 0310-6145-30 Kombiglyze XR

Saxagliptin And Metformin Hydrochloride Tablet, Film Coated, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

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:
0310-6145-30
Package Description:
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code:
0310-6145
Proprietary Name:
Kombiglyze XR
Non-Proprietary Name:
Saxagliptin And Metformin Hydrochloride
Substance Name:
Metformin Hydrochloride; Saxagliptin Hydrochloride
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:
00310614530
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1043563 - sAXagliptin 2.5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1043563 - 24 HR metformin hydrochloride 1000 MG / saxagliptin 2.5 MG Extended Release Oral Tablet
  • RxCUI: 1043563 - metformin hydrochloride 1000 MG / saxagliptin (as saxagliptin hydrochloride) 2.5 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 1043567 - kombiglyze XR 2.5 MG / 1000 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1043567 - 24 HR metformin hydrochloride 1000 MG / saxagliptin 2.5 MG Extended Release Oral Tablet [Kombiglyze]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Astrazeneca Pharmaceuticals Lp
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • METFORMIN HYDROCHLORIDE 1000 mg/1
  • SAXAGLIPTIN HYDROCHLORIDE 5 mg/1
    • Pharmacologic Class(es):
  • Biguanide - [EPC] (Established Pharmacologic Class)
  • Biguanides - [CS]
  • Dipeptidyl Peptidase 4 Inhibitor - [EPC] (Established Pharmacologic Class)
  • Dipeptidyl Peptidase 4 Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA200678
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    12-04-2014
    Listing Expiration Date:
    12-31-2024
    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.

    Frequently Asked Questions

    What is NDC 0310-6145-30?

    The NDC Packaged Code 0310-6145-30 is assigned to a package of 30 tablet, film coated, extended release in 1 bottle, plastic of Kombiglyze XR, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. The product's dosage form is tablet, film coated, extended release and is administered via oral form.

    Is NDC 0310-6145 included in the NDC Directory?

    Yes, Kombiglyze XR with product code 0310-6145 is active and included in the NDC Directory. The product was first marketed by Astrazeneca Pharmaceuticals Lp on December 04, 2014 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0310-6145-30?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 30.

    What is the 11-digit format for NDC 0310-6145-30?

    The 11-digit format is 00310614530. 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
    4-4-20310-6145-305-4-200310-6145-30