FDA.reportPublic FDA data

Trijardy XR

Product NDC
0597-0395
11-digit product format
005970395
Labeler code
0597
Product ID
0597-0395_ca86ce8b-9c04-47d8-94e3-ae041f251fab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
empagliflozin, linagliptin, metformin hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Boehringer Ingelheim Pharmaceuticals, Inc.
Application
NDA212614
Marketing category
NDA
Marketing start
2020-04-23
Substance
EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Active strength
5; 2.5; 1000 mg/1; mg/1; mg/1
Pharmacologic 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
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Trijardy XR
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EMPAGLIFLOZIN5 mg/1
LINAGLIPTIN2.5 mg/1
METFORMIN HYDROCHLORIDE1000 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHDC1R2M35U, 786Z46389E, 3X29ZEJ4R2
Rxcui2359279, 2359285, 2359288, 2359290, 2359351, 2359353, 2359356, 2359358

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6a29d87d-f465-752d-5fa9-bd728c608ca2Product name420251215
f6d21fb1-2c09-48ab-8d89-eeadf5a9698eProduct name120250724
a985afd1-89a8-bfab-0231-b59db1a3a9b5Product name720250515
b15b11c6-be06-b86a-2026-0a2ad3876555Product name320250429
25bfaa4d-02a1-402c-96ec-9bf6e625484cProduct name120250307
08b60e13-e5d0-74ca-b5a8-e6df9cb1dca0Product name220240829
16dbe107-66d5-47b3-57ed-0cba6a8dfcccProduct name620240215
08b3e508-8c7e-3b95-0275-113510642fc6Product name220220309
3a90349e-ff2e-41bd-a106-b368fbc1c1f8Product name120200612
5ab9c07d-ba46-4f19-88f9-a3bc7929fb86Product name120200214
1dc427fa-8c3b-4309-981e-ea1ff01326e5Product name120190731
ca3f036c-6c06-b829-b379-1a3a4097099cProduct name920180605
e1ede89f-54c8-428f-ae84-9e8a2deb67dbProduct name120180306
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52cProduct name220170824
bea938a6-c880-985b-d27b-b59b0d8b5a77Product name320170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2fProduct name120170616
e2382c7e-9e14-4196-aeff-98e2cfaf63cbProduct name120170224
a1e505bd-ab91-46e4-b7bc-a43a10199330Product name220170214
988f737f-e7e9-4613-8558-824b1ab755f9Product name120161128
58b66776-50d5-434f-916f-958ccf131e0eProduct name120160713
3e9b6ece-066b-2ac3-28f7-5e13060e5934Product name220151109
2988466d-5fc4-4430-9cee-fc9132f02d2cProduct name120150910
85cbb42f-1a8d-f945-f85e-188e823b7f5bProduct name220150731
24acbc89-fd6a-458c-aa62-a3485b119bedProduct name120150323
e740bf83-275a-4f0c-adf4-ec60ebd882b7Product name120150105
8d7b9e2e-c1f8-4f6e-a1f3-e4ce405be5f0Product name120141205
0d79b284-47e8-e90c-f249-892b9b251003Product name120140508
25391a6f-d1ba-6bff-d36e-050dc68ef0e6Product name120140508
2de6e143-c970-2061-1b77-61c3aa8f4026Product name120140508
2dee091b-3b8c-d27a-b1ba-fcb0d32e776aProduct name120140508
ce63c1f8-ba50-8a17-9290-94522d75daffProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0597-0395-23Trijardy XR180 in 1 BOTTLETABLET, EXTENDED RELEASE18010
0597-0395-52Trijardy XR14 in 1 BOTTLETABLET, EXTENDED RELEASE1410
0597-0395-52Trijardy XR1 in 1 CARTONTABLET, EXTENDED RELEASE110
0597-0395-82Trijardy XR60 in 1 BOTTLETABLET, EXTENDED RELEASE6010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0597-0395-23EA - Each0597-03950fc04eee-f478-4e56-946e-481a290d124712020-04-20
0597-0395-82EA - Each0597-03953d1a2b9f-26b5-4b5c-9c15-59d126182cda12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0597-0395TRIJARDY XR (EMPAGLIFLOZIN, LINAGLIPTIN, METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 4 package rows20240628_71873567-9594-452a-bb92-34a129adecac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2359279empagliflozin 10 MG / linagliptin 5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral TabletPSN71873567-9594-452a-bb92-34a129adecac10
2359288empagliflozin 12.5 MG / linagliptin 2.5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral TabletPSN71873567-9594-452a-bb92-34a129adecac10
2359351empagliflozin 25 MG / linagliptin 5 MG / metFORMIN hydrochloride 1000 MG 24HR Extended Release Oral TabletPSN71873567-9594-452a-bb92-34a129adecac10
2359356empagliflozin 5 MG / linagliptin 2.5 MG / metFORMIN hydrochloride 1000 MG 24HR Extended Release Oral TabletPSN71873567-9594-452a-bb92-34a129adecac10
2359285Trijardy XR 10 MG / 5 MG / 1000 MG 24HR Extended Release Oral TabletPSN71873567-9594-452a-bb92-34a129adecac10
2359290Trijardy XR 12.5 MG / 2.5 MG / 1000 MG 24HR Extended Release Oral TabletPSN71873567-9594-452a-bb92-34a129adecac10
2359353Trijardy XR 25 MG / 5 MG / 1000 MG 24HR Extended Release Oral TabletPSN71873567-9594-452a-bb92-34a129adecac10
2359358Trijardy XR 5 MG / 2.5 MG / 1000 MG 24HR Extended Release Oral TabletPSN71873567-9594-452a-bb92-34a129adecac10
235928524 HR empagliflozin 10 MG / linagliptin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Trijardy]SBD71873567-9594-452a-bb92-34a129adecac10
235929024 HR empagliflozin 12.5 MG / linagliptin 2.5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Trijardy]SBD71873567-9594-452a-bb92-34a129adecac10
235935324 HR empagliflozin 25 MG / linagliptin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Trijardy]SBD71873567-9594-452a-bb92-34a129adecac10
235935824 HR empagliflozin 5 MG / linagliptin 2.5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Trijardy]SBD71873567-9594-452a-bb92-34a129adecac10
235927924 HR empagliflozin 10 MG / linagliptin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral TabletSCD71873567-9594-452a-bb92-34a129adecac10
235928824 HR empagliflozin 12.5 MG / linagliptin 2.5 MG / metformin hydrochloride 1000 MG Extended Release Oral TabletSCD71873567-9594-452a-bb92-34a129adecac10
235935124 HR empagliflozin 25 MG / linagliptin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral TabletSCD71873567-9594-452a-bb92-34a129adecac10
235935624 HR empagliflozin 5 MG / linagliptin 2.5 MG / metformin hydrochloride 1000 MG Extended Release Oral TabletSCD71873567-9594-452a-bb92-34a129adecac10
235927924 HR empagliflozin 10 MG / linagliptin 5 MG / metformin hydrochloride 1000 MG 24HR Extended Release Oral TabletSY71873567-9594-452a-bb92-34a129adecac10
2359288empagliflozin 12.5 MG / linagliptin 2.5 MG / metformin HCl 1000 MG 24HR Extended Release Oral TabletSY71873567-9594-452a-bb92-34a129adecac10
2359285Trijardy XR (empagliflozin 10 MG / linagliptin 5 MG / metformin HCl 1000 MG) 24HR Extended Release Oral TabletSY71873567-9594-452a-bb92-34a129adecac10
2359290Trijardy XR (empagliflozin 12.5 MG / linagliptin 2.5 MG / metformin HCl 1000 MG) 24HR Extended Release Oral TabletSY71873567-9594-452a-bb92-34a129adecac10
2359353Trijardy XR (empagliflozin 25 MG / linagliptin 5 MG / metformin HCl 1000 MG) 24HR Extended Release Oral TabletSY71873567-9594-452a-bb92-34a129adecac10
2359358Trijardy XR (empagliflozin 5 MG / linagliptin 2.5 MG / metformin hydrochloride 1000 MG) 24HR Extended Release Oral TabletSY71873567-9594-452a-bb92-34a129adecac10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0597-0395-2300597039523180 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0395-23) 2020-04-230000-00-00NoNoCurrent
0597-0395-52005970395521 BOTTLE in 1 CARTON (0597-0395-52) > 14 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2020-04-230000-00-00NoNoCurrent
0597-0395-820059703958260 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0395-82) 2020-04-230000-00-00NoNoCurrent