Synjardy Tablet
NDC Package 0597-0175-66

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

Synjardy (empagliflozin and metformin hydrochloride) tablets is a medication a combination of 2 drugs: empagliflozin and metformin. This formulation utilizes a tablet delivery system. Marketed by Boehringer Ingelheim Pharmaceuticals, Inc., this product is identified by NDC 0597-0175 and is authorized under FDA application NDA206111.

Identification & Billing

NDC Package Code
0597-0175-66
Package Description
1 BOTTLE in 1 CARTON / 14 TABLET in 1 BOTTLE
Product Code
0597-0175
11-Digit Billing Format
00597017566
RxNorm Crosswalk
  • RxCUI: 1664315 - empagliflozin 5 MG / metFORMIN HCl 500 MG Oral Tablet
  • RxCUI: 1664315 - empagliflozin 5 MG / metformin hydrochloride 500 MG Oral Tablet
  • RxCUI: 1664321 - Synjardy 5 MG / 500 MG Oral Tablet
  • RxCUI: 1664321 - empagliflozin 5 MG / metformin hydrochloride 500 MG Oral Tablet [Synjardy]
  • RxCUI: 1664321 - Synjardy (empagliflozin 5 MG / metformin hydrochloride 500 MG) Oral Tablet

Clinical Specifications

Proprietary Name
Synjardy
Non-Proprietary Name
Empagliflozin And Metformin Hydrochloride
Substance Name
Empagliflozin; Metformin Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Boehringer Ingelheim Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA206111
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-26-2015
Listing Expiration
12-31-2027
Exclude Flag
N
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 (0597-0175). Click a package code to view its specific billing and regulatory data.

0597-0175-18
180 TABLET in 1 BOTTLE
0597-0175-60
60 TABLET in 1 BOTTLE

* 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 0597-0175-66 identifies a specific commercial package of 1 bottle in 1 carton / 14 tablet in 1 bottle of Synjardy, a human prescription drug labeled by Boehringer Ingelheim Pharmaceuticals, Inc.. This tablet is formulated for oral use and contains empagliflozin; metformin hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Boehringer Ingelheim Pharmaceuticals, Inc. on August 26, 2015. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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.

How is this Boehringer Ingelheim Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00597017566. 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)
0597-0175-66
11-Digit CMS (5-4-2)
00597-0175-66

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