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  5. NDC Package Code: 0597-0295-78 Synjardy XR

NDC Package 0597-0295-78 Synjardy XR

Empagliflozin,Metformin Hydrochloride Tablet, 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:
0597-0295-78
Package Description:
90 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code:
0597-0295
Proprietary Name:
Synjardy XR
Non-Proprietary Name:
Empagliflozin, Metformin Hydrochloride
Substance Name:
Empagliflozin; Metformin Hydrochloride
Usage Information:
This medication is a combination of 2 drugs: empagliflozin and metformin. 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. This medication works by helping to restore your body's proper response to the insulin you naturally produce. It also increases the removal of sugar by your kidneys, decreases how much sugar is made in your liver, and decreases how much sugar your body takes in through your stomach and intestines.
11-Digit NDC Billing Format:
00597029578
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: 1862685 - empagliflozin 10 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1862685 - 24 HR empagliflozin 10 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet
  • RxCUI: 1862685 - empagliflozin 10 MG / metformin HCl 1000 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1862688 - Synjardy XR 10 MG / 1000 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1862688 - 24 HR empagliflozin 10 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Synjardy]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Boehringer Ingelheim Pharmaceuticals, Inc.
    Dosage Form:
    Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • EMPAGLIFLOZIN 25 mg/1
  • METFORMIN HYDROCHLORIDE 1000 mg/1
    • Pharmacologic Class(es):
  • Biguanide - [EPC] (Established Pharmacologic Class)
  • Biguanides - [CS]
  • Sodium-Glucose Cotransporter 2 Inhibitor - [EPC] (Established Pharmacologic Class)
  • Sodium-Glucose Transporter 2 Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA208658
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    12-10-2016
    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
    0597-0295-611 BOTTLE in 1 CARTON / 7 TABLET, EXTENDED RELEASE in 1 BOTTLE
    0597-0295-8830 TABLET, EXTENDED RELEASE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0597-0295-78?

    The NDC Packaged Code 0597-0295-78 is assigned to a package of 90 tablet, extended release in 1 bottle of Synjardy XR, a human prescription drug labeled by Boehringer Ingelheim Pharmaceuticals, Inc.. The product's dosage form is tablet, extended release and is administered via oral form.

    Is NDC 0597-0295 included in the NDC Directory?

    Yes, Synjardy XR with product code 0597-0295 is active and included in the NDC Directory. The product was first marketed by Boehringer Ingelheim Pharmaceuticals, Inc. on December 10, 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 0597-0295-78?

    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 0597-0295-78?

    The 11-digit format is 00597029578. 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
    4-4-20597-0295-785-4-200597-0295-78