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  5. NDC Package Code: 0597-0164-30 Glyxambi

NDC Package 0597-0164-30 Glyxambi

Empagliflozin And Linagliptin Tablet, Film Coated 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:
0597-0164-30
Package Description:
30 TABLET, FILM COATED in 1 BOTTLE
Product Code:
0597-0164
Proprietary Name:
Glyxambi
Non-Proprietary Name:
Empagliflozin And Linagliptin
Substance Name:
Empagliflozin; Linagliptin
Usage Information:
This medication is a combination of 2 drugs: empagliflozin and linagliptin. 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. Empagliflozin works by increasing the removal of sugar by your kidneys. 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.
11-Digit NDC Billing Format:
00597016430
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: 1602109 - empagliflozin 10 MG / linagliptin 5 MG Oral Tablet
  • RxCUI: 1602115 - Glyxambi 10 MG / 5 MG Oral Tablet
  • RxCUI: 1602115 - empagliflozin 10 MG / linagliptin 5 MG Oral Tablet [Glyxambi]
  • RxCUI: 1602115 - Glyxambi (empagliflozin 10 MG / linagliptin 5 MG) Oral Tablet
  • RxCUI: 1602118 - empagliflozin 25 MG / linagliptin 5 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Boehringer Ingelheim Pharmaceuticals, Inc.
    Dosage Form:
    Tablet, Film Coated - 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.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • EMPAGLIFLOZIN 25 mg/1
  • LINAGLIPTIN 5 mg/1
    • Pharmacologic Class(es):
  • Dipeptidyl Peptidase 4 Inhibitor - [EPC] (Established Pharmacologic Class)
  • Dipeptidyl Peptidase 4 Inhibitors - [MoA] (Mechanism of Action)
  • Sodium-Glucose Cotransporter 2 Inhibitor - [EPC] (Established Pharmacologic Class)
  • Sodium-Glucose Transporter 2 Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA206073
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    01-30-2015
    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
    0597-0164-071 BOTTLE in 1 CARTON / 7 TABLET, FILM COATED in 1 BOTTLE
    0597-0164-3930 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED in 1 BLISTER PACK
    0597-0164-9090 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0597-0164-30?

    The NDC Packaged Code 0597-0164-30 is assigned to a package of 30 tablet, film coated in 1 bottle of Glyxambi, a human prescription drug labeled by Boehringer Ingelheim Pharmaceuticals, Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 0597-0164 included in the NDC Directory?

    Yes, Glyxambi with product code 0597-0164 is active and included in the NDC Directory. The product was first marketed by Boehringer Ingelheim Pharmaceuticals, Inc. on January 30, 2015 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 0597-0164-30?

    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 0597-0164-30?

    The 11-digit format is 00597016430. 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
    4-4-20597-0164-305-4-200597-0164-30