FDA.reportPublic FDA data

NDC 59368-389 - Trijardy XR

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
59368-389
Package NDCs from labels
59368-389-01
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
Trijardy XR - 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 11 of 19 · 379 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.c72cfd1a-dce9-43a3-88e2-3cf1d9078b522025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Glipizide and Metformin HydrochlorideGLIPIZIDE AND METFORMIN HYDROCHLORIDEAvKARE13be49d2-0ce9-a78a-e557-ded85ddc808f2025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals, Inc.403349a1-ec19-8982-e063-6294a90aa0602025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin hydrochlorideMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals, Inc.4be72741-4f6d-6689-e054-00144ff8d46c2025-09-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDECoupler LLC3eeee3b7-188a-05a0-e063-6294a90a18532025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
MetforminMETFORMINCoupler LLC3edc9b51-ddee-61f8-e063-6294a90ad3c52025-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Sitagliptin and Metformin HydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDESandoz Inca0fcdc08-0afc-4912-a126-3efea6bc8c612025-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEAscend Laboratories, LLC8c7835fa-3f68-4850-b1da-34893bafb4852025-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
TradjentaLINAGLIPTINCardinal Health 107, LLCdfe327e8-f6ab-41e5-bdef-d520118cd83a2025-08-27Warnings, Adverse reactionsExact identifier
unii: 3X29ZEJ4R2
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC3d450933-8d9d-27de-e063-6294a90ae6d92025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepackf2318509-9a49-4c99-a08b-22381f17aacd2025-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC3cbb802d-d493-255e-e063-6294a90a32f22025-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions53ba7031-be87-47a5-ade7-494c6c489cc62025-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.e1ebb146-acfd-4301-a79c-f5bb243f85752025-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.e55ee270-5eb9-4848-8529-9af2a79669c02025-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HCLMETFORMIN HCLDirect_Rx2ffeb25a-76a9-01e6-e063-6394a90ae3322025-07-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HCLMETFORMIN HCLDirect_Rx3ac4e864-4b8a-13b1-e063-6294a90ada662025-07-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC3ab4efb6-bd30-2583-e063-6294a90a415b2025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
ZITUVIMET XRSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Pharmaceuticals USA Inc.2f635b36-e86a-4e53-8eaf-589917b5f3422025-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutions72dbc087-9a84-4126-bf54-c5254a8b129c2025-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E

Reported adverse events (FAERS/openFDA)#

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