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  5. NDC Package Code: 0597-0275-81 Jentadueto Xr

NDC Package 0597-0275-81 Jentadueto Xr

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

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
0597-0275-81
Package Description:
90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code:
0597-0275
Proprietary Name:
Jentadueto Xr
Non-Proprietary Name:
Linagliptin And Metformin Hydrochloride
Substance Name:
Linagliptin; Metformin Hydrochloride
Usage Information:
Linagliptin/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: linagliptin and metformin. Linagliptin 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 works by helping to restore your body's proper response to the insulin you naturally produce. It also decreases the amount of sugar that your liver makes and that your stomach/intestines absorb.
11-Digit NDC Billing Format:
00597027581
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
90 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1796089 - linagliptin 2.5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1796089 - 24 HR linagliptin 2.5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet
  • RxCUI: 1796089 - linagliptin 2.5 MG / metformin HCl 1000 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1796091 - Jentadueto XR 2.5 MG / 1000 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1796091 - 24 HR linagliptin 2.5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Jentadueto]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Boehringer Ingelheim Pharmaceuticals, Inc.
    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):
  • LINAGLIPTIN 5 mg/1
  • METFORMIN HYDROCHLORIDE 1000 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:
    NDA208026
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    05-27-2016
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0597-0275-3330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
    0597-0275-881 BOTTLE in 1 CARTON / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0597-0275-81?

    The NDC Packaged Code 0597-0275-81 is assigned to a package of 90 tablet, film coated, extended release in 1 bottle of Jentadueto Xr, a human prescription drug labeled by Boehringer Ingelheim Pharmaceuticals, Inc.. The product's dosage form is tablet, film coated, extended release and is administered via oral form.

    Is NDC 0597-0275 included in the NDC Directory?

    Yes, Jentadueto Xr with product code 0597-0275 is active and included in the NDC Directory. The product was first marketed by Boehringer Ingelheim Pharmaceuticals, Inc. on May 27, 2016 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 0597-0275-81?

    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 90.

    What is the 11-digit format for NDC 0597-0275-81?

    The 11-digit format is 00597027581. 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
    4-4-20597-0275-815-4-200597-0275-81