Synjardy Tablet, Extended Release
NDC Package 0597-0290-74
Package Information
Synjardy (empagliflozin, metformin hydrochloride) tablets is a medication a combination of 2 drugs: empagliflozin and metformin. This formulation utilizes a tablet, extended release delivery system. Marketed by Boehringer Ingelheim Pharmaceuticals, Inc., this product is identified by NDC 0597-0290 and is authorized under FDA application NDA208658.
Identification & Billing
- 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]
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 0597 - Boehringer Ingelheim Pharmaceuticals, Inc.
- 0597-0290 - Synjardy
- 0597-0290-74 - 60 TABLET, EXTENDED RELEASE in 1 BOTTLE
- 0597-0290 - Synjardy
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 (0597-0290). Click a package code to view its specific billing and regulatory data.
* 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 0597-0290-74 identifies a specific commercial package of 60 tablet, extended release in 1 bottle of Synjardy XR, a human prescription drug labeled by Boehringer Ingelheim Pharmaceuticals, Inc.. This tablet, extended release 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 December 10, 2016. 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: 00597029074. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 total billable units per package. 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:
Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.
