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 17 of 19 · 379 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions7cc82387-8bb0-4bee-9967-cb13eab1d8012024-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCb090b18b-b53c-4c92-892f-d11551cfedc32023-12-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC38687872-ca68-4965-b317-637c25ba041e2023-11-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
alogliptin and metformin hydrochlorideALOGLIPTIN AND METFORMIN HYDROCHLORIDEA-S Medication Solutions9112d6b9-4771-4194-886d-7db887470bcc2023-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsd0bc43a4-301f-4002-9b58-bd81dddf27902023-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsa4679179-af2d-4c84-a1c8-ab0870a4585d2023-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEVGYAAN Pharmaceuticals LLC129ff158-097f-401a-8924-d9258465c1f32023-09-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsd60139c2-fd35-4ab4-af7e-7410481edc2e2023-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HClMETFORMIN HCLA-S Medication Solutions74f18a3e-0f5c-4172-b499-14f229b431c42023-09-10Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
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
JANUMET XRSITAGLIPTIN AND METFORMIN HYDROCHLORIDEA-S Medication Solutions90c0244b-afb3-4e69-b79f-486d002ca4322023-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LP1b9b6db9-1bac-4252-a03c-18dc0271f05f2023-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepack88af3365-1145-45a1-ab0f-1c794f0c13db2023-05-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HClMETFORMIN HCLBryant Ranch Prepack4bdd2faa-2125-4139-b958-196393e31b7e2023-05-24Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
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
Metformin hydrochloride ERMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC1ebaab3a-3d62-4c36-853f-c8784993eafb2023-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepack86627ff4-da1c-429d-991b-88e97f6967d62023-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepack8ce6b615-2abd-4a5b-997b-11aa1aec142d2023-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E

Reported adverse events (FAERS/openFDA)#

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