Home NDC 0597-0385 Trijardy XR
Product NDC 0597-0385
11-digit product format 005970385
Labeler code 0597
Product ID 0597-0385_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 12.5; 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N212614-001 TRIJARDY XR EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE 5MG;2.5MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD 2020-01-27 N212614-002 TRIJARDY XR EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE 10MG;5MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD 2020-01-27 N212614-003 TRIJARDY XR EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE 12.5MG;2.5MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD 2020-01-27 N212614-004 TRIJARDY XR EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE 25MG;5MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD, RS 2020-01-27
Orange Book patents# Current patent rows page 1 of 2 · 111 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N212614-001 TRIJARDY XR 5MG;2.5MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD 2020-01-27 a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-002 TRIJARDY XR 10MG;5MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD 2020-01-27 a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-003 TRIJARDY XR 12.5MG;2.5MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD 2020-01-27 a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-004 TRIJARDY XR 25MG;5MG;1GM TABLET, EXTENDED RELEASE / ORAL RLD, RS 2020-01-27 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 111 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N212614-001 8883805 2025-11-26 Drug product 2020-02-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-001 8883805*PED 2026-05-26 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-001 7713938 2027-04-15 Drug substance, Drug product 2020-02-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-001 7713938*PED 2027-10-15 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-001 7579449 2028-08-01 Drug substance 2020-02-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-001 7579449*PED 2029-02-01 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-001 10022379 2029-04-02 U-2732 Drug product 2020-02-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-001 9415016 2029-04-02 Drug product 2020-02-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-001 8551957 2029-10-14 U-2730 Drug product 2020-02-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-001 12115179 2030-02-11 U-4023 2024-11-12 a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-001 8551957*PED 2030-04-14 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-001 9155705 2030-05-21 Drug product 2020-02-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-001 10406172 2030-06-15 U-2733 Drug product 2020-02-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-001 12115179*PED 2030-08-11 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-001 10596120 2032-03-07 U-2790 Drug product 2020-04-21 a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-001 10596120 2032-03-07 U-2776 Drug product 2020-04-21 a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-001 11564886 2032-03-07 U-3531 Drug product 2023-03-01 a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-001 10258637 2034-04-03 U-2731 2020-02-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-001 11090323 2034-04-03 U-3192 2021-08-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-001 11833166 2034-04-03 U-3776 2024-01-03 a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-001 11833166 2034-04-03 U-3777 2024-01-03 a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-001 9949998 2034-06-11 U-2731 2020-02-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-001 10258637*PED 2034-10-03 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-001 11090323*PED 2034-10-03 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-001 11833166*PED 2034-10-03 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-001 9949998*PED 2034-12-11 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-001 12364700 2037-06-08 U-4224 2025-07-31 a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-001 12364700*PED 2037-12-08 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-002 8883805 2025-11-26 Drug product 2020-02-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-002 8883805*PED 2026-05-26 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-002 7713938 2027-04-15 Drug substance, Drug product 2020-02-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-002 7713938*PED 2027-10-15 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-002 7579449 2028-08-01 Drug substance 2020-02-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-002 7579449*PED 2029-02-01 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-002 10022379 2029-04-02 U-2732 Drug product 2020-02-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-002 9415016 2029-04-02 Drug product 2020-02-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-002 8551957 2029-10-14 U-2730 Drug product 2020-02-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-002 12115179 2030-02-11 U-4023 2024-11-12 a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-002 8551957*PED 2030-04-14 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N212614-002 9155705 2030-05-21 Drug product 2020-02-18 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Trijardy XR EMPAGLIFLOZIN, LINAGLIPTIN, METFORMIN HYDROCHLORIDE Boehringer Ingelheim Pharmaceuticals, Inc. 71873567-9594-452a-bb92-34a129adecac 2026-01-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 212614 application number: NDA212614 ndc (product): 0597-0385
Additional Listing Data#
Finished product Yes
Brand name base Trijardy XR
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EMPAGLIFLOZIN 12.5 mg/1 LINAGLIPTIN 2.5 mg/1 METFORMIN HYDROCHLORIDE 1000 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 786Z46389E Internal UNII lookup HDC1R2M35U Internal UNII lookup 3X29ZEJ4R2 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2359279 Internal RxNorm lookup 2359285 Internal RxNorm lookup 2359288 Internal RxNorm lookup 2359290 Internal RxNorm lookup 2359351 Internal RxNorm lookup 2359353 Internal RxNorm lookup 2359356 Internal RxNorm lookup 2359358 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0597-0385-77 Trijardy XR 60 in 1 BOTTLE TABLET, EXTENDED RELEASE 60 10 0597-0385-86 Trijardy XR 180 in 1 BOTTLE TABLET, EXTENDED RELEASE 180 10 0597-0385-88 Trijardy XR 1 in 1 CARTON TABLET, EXTENDED RELEASE 1 10 0597-0385-88 Trijardy XR 14 in 1 BOTTLE TABLET, EXTENDED RELEASE 14 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0597-0385 TRIJARDY XR (EMPAGLIFLOZIN, LINAGLIPTIN, METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 7 Current NDC, Legacy NDC, 4 package rows 20240628_71873567-9594-452a-bb92-34a129adecac.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0597-0385-77 00597038577 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0385-77) 2020-04-23 0000-00-00 No No Current 0597-0385-86 00597038586 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0385-86) 2020-04-23 0000-00-00 No No Current 0597-0385-88 00597038588 1 BOTTLE in 1 CARTON (0597-0385-88) > 14 TABLET, EXTENDED RELEASE in 1 BOTTLE 1 bottle 2020-04-23 0000-00-00 No No Current