trijardy xr

Generic: empagliflozin, linagliptin, metformin hydrochloride

Labeler: boehringer ingelheim pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name trijardy xr
Generic Name empagliflozin, linagliptin, metformin hydrochloride
Labeler boehringer ingelheim pharmaceuticals, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

empagliflozin 10 mg/1, linagliptin 5 mg/1, metformin hydrochloride 1000 mg/1

Manufacturer
Boehringer Ingelheim Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0597-0380
Product ID 0597-0380_ca86ce8b-9c04-47d8-94e3-ae041f251fab
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA212614
Listing Expiration 2027-12-31
Marketing Start 2020-04-23

Pharmacologic Class

Established (EPC)
sodium-glucose cotransporter 2 inhibitor [epc] dipeptidyl peptidase 4 inhibitor [epc]
Mechanism of Action
sodium-glucose transporter 2 inhibitors [moa] dipeptidyl peptidase 4 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05970380
Hyphenated Format 0597-0380

Supplemental Identifiers

RxCUI
2359279 2359285 2359288 2359290 2359351 2359353 2359356 2359358
UNII
HDC1R2M35U 3X29ZEJ4R2 786Z46389E
NUI
N0000187059 N0000187058 N0000175912 N0000175913

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name trijardy xr (source: ndc)
Generic Name empagliflozin, linagliptin, metformin hydrochloride (source: ndc)
Application Number NDA212614 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
  • 5 mg/1
  • 1000 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0380-13)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0380-68)
source: ndc

Packages (2)

0597-0380-13 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0380-13) 0597-0380-68 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0380-68)

Ingredients (3)

empagliflozin (10 mg/1) linagliptin (5 mg/1) metformin hydrochloride (1000 mg/1)

Linked Drug Pages (1)

Trijardy XR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ca86ce8b-9c04-47d8-94e3-ae041f251fab", "openfda": {"nui": ["N0000187059", "N0000187058", "N0000175912", "N0000175913"], "unii": ["HDC1R2M35U", "3X29ZEJ4R2", "786Z46389E"], "rxcui": ["2359279", "2359285", "2359288", "2359290", "2359351", "2359353", "2359356", "2359358"], "spl_set_id": ["71873567-9594-452a-bb92-34a129adecac"], "pharm_class_epc": ["Sodium-Glucose Cotransporter 2 Inhibitor [EPC]", "Dipeptidyl Peptidase 4 Inhibitor [EPC]"], "pharm_class_moa": ["Sodium-Glucose Transporter 2 Inhibitors [MoA]", "Dipeptidyl Peptidase 4 Inhibitors [MoA]"], "manufacturer_name": ["Boehringer Ingelheim Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0380-13)", "package_ndc": "0597-0380-13", "marketing_start_date": "20200423"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0380-68)", "package_ndc": "0597-0380-68", "marketing_start_date": "20200423"}], "brand_name": "Trijardy XR", "product_id": "0597-0380_ca86ce8b-9c04-47d8-94e3-ae041f251fab", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["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]"], "product_ndc": "0597-0380", "generic_name": "empagliflozin, linagliptin, metformin hydrochloride", "labeler_name": "Boehringer Ingelheim Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Trijardy XR", "active_ingredients": [{"name": "EMPAGLIFLOZIN", "strength": "10 mg/1"}, {"name": "LINAGLIPTIN", "strength": "5 mg/1"}, {"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "NDA212614", "marketing_category": "NDA", "marketing_start_date": "20200423", "listing_expiration_date": "20271231"}