Home NDC 0597-0180 Synjardy
Product NDC 0597-0180
11-digit product format 005970180
Labeler code 0597
Product ID 0597-0180_06cb5e7a-ca7a-474a-a968-b3ddc7af1c43
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name empagliflozin and metformin hydrochloride
Dosage form TABLET
Route ORAL
Labeler Boehringer Ingelheim Pharmaceuticals, Inc.
Application NDA206111
Marketing category NDA
Marketing start 2015-08-26
Substance EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Active strength 12.5; 500 mg/1; mg/1
Pharmacologic classes Biguanide [EPC], Biguanides [CS], 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 N206111-001 SYNJARDY EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET / ORAL RLD 2015-08-26 N206111-002 SYNJARDY EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;1GM TABLET / ORAL RLD 2015-08-26 N206111-003 SYNJARDY EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 12.5MG;500MG TABLET / ORAL RLD 2015-08-26 N206111-004 SYNJARDY EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 12.5MG;1GM TABLET / ORAL RLD, RS 2015-08-26
Orange Book patents# Current patent rows page 1 of 2 · 120 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 8 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 N206111-001 SYNJARDY 5MG;500MG TABLET / ORAL RLD 2015-08-26 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-002 SYNJARDY 5MG;1GM TABLET / ORAL RLD 2015-08-26 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-003 SYNJARDY 12.5MG;500MG TABLET / ORAL RLD 2015-08-26 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-004 SYNJARDY 12.5MG;1GM TABLET / ORAL RLD, RS 2015-08-26 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 120 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 N206111-001 7713938 2027-04-15 Drug substance, Drug product 2015-09-30 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 7713938*PED 2027-10-15 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 7579449 2028-08-01 Drug substance 2015-09-30 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 7579449*PED 2029-02-01 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 12115179 2030-02-11 U-4023 2024-11-12 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 12115179*PED 2030-08-11 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 10610489 2030-09-30 Drug product 2020-05-01 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 10610489*PED 2031-03-30 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 12527810 2033-04-22 U-4403 2026-02-10 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 12527810*PED 2033-10-22 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 10258637 2034-04-03 U-2290 2019-04-30 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 11090323 2034-04-03 U-3193 2021-08-20 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 11666590 2034-04-03 U-4154 2025-03-28 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 11813275 2034-04-03 U-3759 2023-12-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 11833166 2034-04-03 U-3776 2024-01-03 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 11833166 2034-04-03 U-3777 2024-01-03 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 12263153 2034-04-03 U-4154 2025-04-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 12427162 2034-04-03 U-4287 2025-10-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 12433906 2034-04-03 U-4304 2025-10-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 12433906 2034-04-03 U-4293 2025-10-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 12433906 2034-04-03 U-4294 2025-10-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 12433906 2034-04-03 U-4295 2025-10-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 12433906 2034-04-03 U-4296 2025-10-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 9949997 2034-05-17 U-3532 2023-03-01 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 9949997 2034-05-17 U-3533 2023-03-01 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 10258637*PED 2034-10-03 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 11090323*PED 2034-10-03 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 11813275*PED 2034-10-03 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 11833166*PED 2034-10-03 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 12433906*PED 2034-10-03 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-001 9949997*PED 2034-11-17 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-002 7713938 2027-04-15 Drug substance, Drug product 2015-09-30 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-002 7713938*PED 2027-10-15 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-002 7579449 2028-08-01 Drug substance 2015-09-30 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-002 7579449*PED 2029-02-01 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-002 12115179 2030-02-11 U-4023 2024-11-12 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-002 12115179*PED 2030-08-11 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-002 10610489 2030-09-30 Drug product 2020-05-01 a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-002 10610489*PED 2031-03-30 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N206111-002 12527810 2033-04-22 U-4403 2026-02-10 a50c72e98297…
Observed Orange Book exclusivity history# 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 Synjardy EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE Boehringer Ingelheim Pharmaceuticals, Inc. 0fdd0255-0055-65f3-b2c0-db8fbb87beae 2026-01-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 206111 application number: NDA206111 ndc (product): 0597-0180
Additional Listing Data#
Finished product Yes
Brand name base Synjardy
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EMPAGLIFLOZIN 12.5 mg/1 METFORMIN HYDROCHLORIDE 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination HDC1R2M35U Internal UNII lookup 786Z46389E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1664315 Internal RxNorm lookup 1664321 Internal RxNorm lookup 1664323 Internal RxNorm lookup 1664325 Internal RxNorm lookup 1664326 Internal RxNorm lookup 1664328 Internal RxNorm lookup 1665367 Internal RxNorm lookup 1665369 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0597-0180 SYNJARDY (EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 20 Current NDC, Legacy NDC, 4 package rows 20250327_0fdd0255-0055-65f3-b2c0-db8fbb87beae.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 0597-0180-18 00597018018 180 TABLET in 1 BOTTLE (0597-0180-18) 180 tablet 2015-09-12 0000-00-00 No No Current 0597-0180-60 00597018060 60 TABLET in 1 BOTTLE (0597-0180-60) 60 tablet 2015-09-12 0000-00-00 No No Current 0597-0180-66 00597018066 1 BOTTLE in 1 CARTON (0597-0180-66) > 14 TABLET in 1 BOTTLE 1 bottle 2015-09-12 0000-00-00 No No Current