Synjardy NDC 0597-0180

NDC codes

FDA NDC Directory

Product NDC (as listed)0597-0180Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00597-0180Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0597-0180-18	00597018018	180 TABLET in 1 BOTTLE (0597-0180-18)Marketed from Sep 12, 2015
0597-0180-60	00597018060	60 TABLET in 1 BOTTLE (0597-0180-60)Marketed from Sep 12, 2015

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Synjardy
Generic name (nonproprietary): empagliflozin and metformin hydrochloride
Active ingredients: Empagliflozin — 12.5 mg/1Metformin hydrochloride — 500 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Boehringer Ingelheim Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 206111
Marketing start: Aug 26, 2015
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
Identifiers: Product ID 0597-0180_74e3dfbf-03de-4d8f-b900-955d45db5ab6SPL ID 74e3dfbf-03de-4d8f-b900-955d45db5ab6SPL set ID 0fdd0255-0055-65f3-b2c0-db8fbb87beaeRxCUI 1664315, 1664321, 1664323, 1664325, 1664326, 1664328, 1665367, 1665369UNII 786Z46389E, HDC1R2M35U
Pharmacologic class: Biguanide; Sodium-Glucose Cotransporter 2 Inhibitor

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400597018018 followed by a unit qualifier and the quantity

Package 00597-0180-18. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Aug 25, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

SYNJARDY SYNJARDY is a combination of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor and metformin hydrochloride (HCl) immediate-release, a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. SYNJARDY XR SYNJARDY XR is a combination of empagliflozin, a SGLT2 inhibitor and metformin HCl extended-release, a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus . Empagliflozin Empagliflozin, when used as a component of SYNJARDY or SYNJARDY XR, is indicated in adults with type 2 diabetes m…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 206111

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 206111
Product	Strength	Form · route	Labeler	Product NDC
Synjardyempagliflozin and metformin hydrochloride	Empagliflozin 5 mg/1; Metformin hydrochloride 500 mg/1	TabletOral	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0159
Synjardyempagliflozin and metformin hydrochloride	Empagliflozin 12.5 mg/1; Metformin hydrochloride 1000 mg/1	TabletOral	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0168
Synjardyempagliflozin and metformin hydrochloride	Empagliflozin 5 mg/1; Metformin hydrochloride 1000 mg/1	TabletOral	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0175