What is NDC 0597-0380?

0597-0380 is the product NDC for Trijardy XR, Empagliflozin 10 mg/1 + 2 more ingredients tablet, extended release, listed with the FDA by Boehringer Ingelheim Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Trijardy XR (Empagliflozin, linagliptin, metformin hydrochloride).

What is the active ingredient?

Empagliflozin, Linagliptin, Metformin hydrochloride.

Boehringer Ingelheim Pharmaceuticals, Inc., NDC labeler code 0597. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Trijardy XR?

3 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Trijardy XR NDC 0597-0380 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0597-0380Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00597-0380Add 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
0597-0380-13	0059703801300597038013	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0380-13)Marketed from Apr 23, 2020
0597-0380-68	0059703806800597038068	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0380-68)Marketed from Apr 23, 2020

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): Trijardy XR
Generic name (nonproprietary): empagliflozin, linagliptin, metformin hydrochloride
Active ingredients: Empagliflozin — 10 mg/1Linagliptin — 5 mg/1Metformin hydrochloride — 1000 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Boehringer Ingelheim Pharmaceuticals, Inc.NDC labeler code 0597
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 212614
Marketing start: Apr 23, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)Dipeptidyl Peptidase 4 Inhibitors (Mechanism)Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
Identifiers: Product ID 0597-0380_40d8f12b-47be-4a48-be56-9cd025ac63d4SPL ID 40d8f12b-47be-4a48-be56-9cd025ac63d4SPL set ID 71873567-9594-452a-bb92-34a129adecacRxCUI 2359279, 2359285, 2359288, 2359290, 2359351, 2359353, 2359356, 2359358UNII 786Z46389E, HDC1R2M35U, 3X29ZEJ4R2
Pharmacologic class: Biguanide; Dipeptidyl Peptidase 4 Inhibitor; 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

N400597038013 followed by a unit qualifier and the quantity

Package 00597-0380-13. 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 24, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

TRIJARDY XR is a combination of empagliflozin, linagliptin, and metformin hydrochloride (HCl) indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus . Empagliflozin is indicated to reduce the risk of cardiovascular (CV) death in adults with type 2 diabetes mellitus and established CV disease [see Clinical Studies (14.2) ] . TRIJARDY XR is a combination of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitu…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0597-0380

What is NDC 0597-0380?: 0597-0380 is the product NDC for Trijardy XR, Empagliflozin 10 mg/1 + 2 more ingredients tablet, extended release, listed with the FDA by Boehringer Ingelheim Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Trijardy XR (Empagliflozin, linagliptin, metformin hydrochloride).
What is the active ingredient?: Empagliflozin, Linagliptin, Metformin hydrochloride.
Who is the labeler?: Boehringer Ingelheim Pharmaceuticals, Inc., NDC labeler code 0597. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Trijardy XR?: 3 other product NDCs are listed under this name. See all Trijardy XR NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Trijardy XR NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Trijardy XRempagliflozin, linagliptin, metformin hydrochloride	Empagliflozin 12.5 mg/1 + 2 more ingredients	Tablet, Extended releaseOral	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0385	00597-0385-7700597-0385-86
Trijardy XRempagliflozin, linagliptin, metformin hydrochloride	Empagliflozin 25 mg/1 + 2 more ingredients	Tablet, Extended releaseOral	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0390	00597-0390-1300597-0390-71
Trijardy XRempagliflozin, linagliptin, metformin hydrochloride	Empagliflozin 5 mg/1 + 2 more ingredients	Tablet, Extended releaseOral	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0395	00597-0395-2300597-0395-82

Other NDCs under NDA 212614

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

FDA NDC Directory listings under NDA 212614
Product	Strength	Form · route	Labeler	Product NDC
Trijardy XRempagliflozin, linagliptin, metformin hydrochloride	Empagliflozin 12.5 mg/1 + 2 more ingredients	Tablet, Extended releaseOral	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0385
Trijardy XRempagliflozin, linagliptin, metformin hydrochloride	Empagliflozin 25 mg/1 + 2 more ingredients	Tablet, Extended releaseOral	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0390
Trijardy XRempagliflozin, linagliptin, metformin hydrochloride	Empagliflozin 5 mg/1 + 2 more ingredients	Tablet, Extended releaseOral	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0395