FDA.reportPublic FDA data

NDC 59368-378-01 - Glyxambi

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
59368-378
Requested NDC
59368-378-01
Package NDCs from labels
59368-378-01
Manufacturer
Praxis, LLC
Effective date
2023-01-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Glyxambi - Praxis, LLCPraxis, LLC2023-01-01HUMAN PRESCRIPTION DRUG LABEL

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JardianceEMPAGLIFLOZINRedpharm Drug59ed43d9-b4e0-72a2-e063-6394a90a327d2026-08-26Warnings, Adverse reactionsExact identifier
unii: HDC1R2M35U
SynjardyEMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEBoehringer Ingelheim Pharmaceuticals, Inc.0fdd0255-0055-65f3-b2c0-db8fbb87beae2026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: HDC1R2M35U
Trijardy XREMPAGLIFLOZIN, LINAGLIPTIN, METFORMIN HYDROCHLORIDEBoehringer Ingelheim Pharmaceuticals, Inc.71873567-9594-452a-bb92-34a129adecac2026-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: HDC1R2M35U
unii: 3X29ZEJ4R2
JentaduetoLINAGLIPTIN AND METFORMIN HYDROCHLORIDEBoehringer Ingelheim Pharmaceuticals, Inc.f6dd9b86-0d18-95d4-2bc7-05591bfdd5972026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3X29ZEJ4R2
Jentadueto XRLINAGLIPTIN AND METFORMIN HYDROCHLORIDEBoehringer Ingelheim Pharmaceuticals, Inc.3d02a4d4-d312-80b4-05c4-691b8f0aa7aa2026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3X29ZEJ4R2
Synjardy XREMPAGLIFLOZIN, METFORMIN HYDROCHLORIDEBoehringer Ingelheim Pharmaceuticals, Inc.8006ba29-ee3a-f852-a9bb-c8ec9b41cf662026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: HDC1R2M35U
JardianceEMPAGLIFLOZINAphena Pharma Solutions - Tennessee, LLC334f1b3d-5670-6685-e063-6294a90a7e472026-06-17Warnings, Adverse reactionsExact identifier
unii: HDC1R2M35U
JardianceEMPAGLIFLOZINCardinal Health 107, LLC5777b8a8-ada6-4950-8548-43a1de11f0752026-02-17Warnings, Adverse reactionsExact identifier
unii: HDC1R2M35U
JardianceEMPAGLIFLOZINBoehringer Ingelheim Pharmaceuticals, Inc.faf3dd6a-9cd0-39c2-0d2e-232cb3f675652026-01-30Warnings, Adverse reactionsExact identifier
unii: HDC1R2M35U
GlyxambiEMPAGLIFLOZIN AND LINAGLIPTINBoehringer Ingelheim Pharmaceuticals, Inc.ddbab689-f76c-488c-9613-4168d41dd7302026-01-20Warnings, Adverse reactionsExact identifier
unii: HDC1R2M35U
unii: 3X29ZEJ4R2
Linagliptin and metformin hydrochlorideLINAGLIPTIN AND METFORMIN HYDROCHLORIDENovadoz Pharmaceuticals LLC5cff87ef-97f9-4e3c-9e06-fd257f3cb3fb2025-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3X29ZEJ4R2
JardianceEMPAGLIFLOZINAphena Pharma Solutions - Tennessee, LLC8b6261f6-4bdc-462e-8af1-4064664c62f32025-10-27Warnings, Adverse reactionsExact identifier
unii: HDC1R2M35U
TradjentaLINAGLIPTINCardinal Health 107, LLCdfe327e8-f6ab-41e5-bdef-d520118cd83a2025-08-27Warnings, Adverse reactionsExact identifier
unii: 3X29ZEJ4R2
TradjentaLINAGLIPTINBoehringer Ingelheim Pharmaceuticals, Inc.c797ea5c-cab7-494b-9044-27eba0cfe40f2025-03-21Warnings, Adverse reactionsExact identifier
unii: 3X29ZEJ4R2
TradjentaLINAGLIPTINA-S Medication Solutionsb1da67d4-51e0-41b7-9fe1-7f38c0d1baa12024-01-22Warnings, Adverse reactionsExact identifier
unii: 3X29ZEJ4R2
JardianceEMPAGLIFLOZINA-S Medication Solutionsa77214ca-572e-485e-aae9-f7950187e5fb2023-08-08Warnings, Adverse reactionsExact identifier
unii: HDC1R2M35U
JARDIANCEEMPAGLIFLOZINA-S Medication Solutions942a82a4-cbbd-4e44-9965-8d03f767912b2023-07-24Warnings, Adverse reactionsExact identifier
unii: HDC1R2M35U
JARDIANCEEMPAGLIFLOZINA-S Medication Solutions1782b947-4a72-4feb-a488-1469d9af82bd2023-05-03Warnings, Adverse reactionsExact identifier
unii: HDC1R2M35U
JARDIANCEEMPAGLIFLOZINA-S Medication Solutionsf2b41c77-0abb-40ee-8578-86a748d0e19e2023-05-03Warnings, Adverse reactionsExact identifier
unii: HDC1R2M35U
36d5e2d3-aad4-8ea3-e063-6294a90aebc836d5d11a-69bb-c05b-e063-6394a90ac06e2023-01-01Exact identifier
spl id: 36d5e2d3-aad4-8ea3-e063-6294a90aebc8
spl set id: 36d5d11a-69bb-c05b-e063-6394a90ac06e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.