NDC 0597-0380

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 ID0597-0380_432f5f3c-a9e4-4ec2-9b10-6848d2dc509e
NDC0597-0380
Product TypeHuman Prescription Drug
Proprietary NameTrijardy XR
Generic NameEmpagliflozin, Linagliptin, Metformin Hydrochloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2020-04-23
Marketing CategoryNDA / NDA
Application NumberNDA212614
Labeler NameBoehringer Ingelheim Pharmaceuticals, Inc.
Substance NameEMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Active Ingredient Strength10 mg/1; mg/1; mg/1
Pharm ClassesBiguanide [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 FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0597-0380-13

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0380-13)
Marketing Start Date2020-04-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0597-0380-68 [00597038068]

Trijardy XR TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA212614
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-04-23

NDC 0597-0380-13 [00597038013]

Trijardy XR TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA212614
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-04-23

NDC 0597-0380-22 [00597038022]

Trijardy XR TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA212614
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-23

Drug Details

Active Ingredients

IngredientStrength
EMPAGLIFLOZIN10 mg/1

OpenFDA Data

SPL SET ID:71873567-9594-452a-bb92-34a129adecac
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    0597-0380Trijardy XRempagliflozin, linagliptin, metformin hydrochloride
    0597-0385Trijardy XRempagliflozin, linagliptin, metformin hydrochloride
    0597-0390Trijardy XRempagliflozin, linagliptin, metformin hydrochloride
    0597-0395Trijardy XRempagliflozin, linagliptin, metformin hydrochloride

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