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 13 of 19 · 379 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetforminMETFORMINCoupler LLC33ecddbe-860a-6ca8-e063-6294a90aac642025-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.103080cb-6381-44f6-8a31-1fc81e7c890f2025-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.33155746-c2ef-12f4-e063-6294a90a039c2025-04-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDETAGI Pharma, Inc.dd0ee2bf-f658-42dc-976d-49af0b1f32b52025-04-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDECoupler, LLC32ff33ed-89ed-c391-e063-6294a90ae4142025-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEBryant Ranch Prepackd7c1ff9e-4faa-4f65-9c87-e8108499791f2025-03-28WarningsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEBryant Ranch Prepack3e55944a-ed5b-4892-804f-abbe15b0d70c2025-03-28WarningsExact identifier
unii: 786Z46389E
TradjentaLINAGLIPTINBoehringer Ingelheim Pharmaceuticals, Inc.c797ea5c-cab7-494b-9044-27eba0cfe40f2025-03-21Warnings, Adverse reactionsExact identifier
unii: 3X29ZEJ4R2
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepackde4a660b-172b-4c72-9e38-5634fd03cfa72025-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Pioglitazone Hydrochloride and Metformin HydrochloridePIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDERising Pharma Holdings, Inc.8d252dab-e868-42d3-95ea-69423d909e842025-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HClMETFORMIN HCLTIME CAP LABORATORIES, INC542cec22-eeae-4704-9bb6-4176640e5ea82025-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDECoupler LLC2d7d9364-e71d-4ef6-e063-6394a90af8412025-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepack4db5551b-04f6-4921-9dee-68acb41f7f712025-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.0865f83f-0f34-0690-e063-6294a90abf042025-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.0b3d5420-d60c-8385-e063-6394a90abb6c2025-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HClMETFORMIN HCLNuCare Pharmaceuticals,Inc.0b3d7c79-9a5a-a82e-e063-6394a90a3caa2025-02-03Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEProficient Rx LPf1530d4f-21d9-4a4f-a814-07b180828ecd2025-02-01WarningsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LP7cb47c3e-6657-4c11-8aa2-ae172e5a85292025-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDELifsa Drugs, LLCa2385bcd-0943-4411-8658-c22b503603852025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDERedPharm Drug, Inc.fc61bafa-a506-14ae-e053-6394a90a9c7d2025-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E

Reported adverse events (FAERS/openFDA)#

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