NDC 0597-0385

Trijardy XR

Empagliflozin, Linagliptin, Metformin Hydrochloride

Trijardy XR is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.. The primary component is Empagliflozin; Linagliptin; Metformin Hydrochloride.

• Product ID: 0597-0385_432f5f3c-a9e4-4ec2-9b10-6848d2dc509e
• NDC: 0597-0385
• Product Type: Human Prescription Drug
• Proprietary Name: Trijardy XR
• Generic Name: Empagliflozin, Linagliptin, Metformin Hydrochloride
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2020-04-23
• Marketing Category: NDA / NDA
• Application Number: NDA212614
• Labeler Name: Boehringer Ingelheim Pharmaceuticals, Inc.
• Substance Name: EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
• Active Ingredient Strength: 13 mg/1; mg/1; mg/1
• Pharm Classes: Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0597-0385-77

60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0385-77)

• Marketing Start Date: 2020-04-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0597-0385-77 [00597038577]

Trijardy XR TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA212614
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2020-04-23

NDC 0597-0385-86 [00597038586]

Trijardy XR TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA212614
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2020-04-23

NDC 0597-0385-88 [00597038588]

Trijardy XR TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA212614
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-04-23

Drug Details

Active Ingredients

Ingredient	Strength
EMPAGLIFLOZIN	12.5 mg/1

OpenFDA Data

• SPL SET ID: 71873567-9594-452a-bb92-34a129adecac
• Manufacturer:
  • Boehringer Ingelheim Pharmaceuticals, Inc.
• UNII:
  • HDC1R2M35U
  • 3X29ZEJ4R2
  • 786Z46389E
• RxNorm Concept Unique ID - RxCUI:
  • 2359290
  • 2359285
  • 2359353
  • 2359279
  • 2359288
  • 2359351
  • 2359356
  • 2359358

Pharmacological Class

• Sodium-Glucose Cotransporter 2 Inhibitor [EPC]
• Sodium-Glucose Transporter 2 Inhibitors [MoA]
• Dipeptidyl Peptidase 4 Inhibitors [MoA]
• Dipeptidyl Peptidase 4 Inhibitor [EPC]
• Biguanide [EPC]
• Biguanides [CS]

NDC Crossover Matching brand name "Trijardy XR" or generic name "Empagliflozin, Linagliptin, Metformin Hydrochloride"

NDC	Brand Name	Generic Name
0597-0380	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride
0597-0385	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride
0597-0390	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride
0597-0395	Trijardy XR	empagliflozin, linagliptin, metformin hydrochloride