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 8 of 19 · 379 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Glipizide and Metformin HydrochlorideGLIPIZIDE AND METFORMIN HYDROCHLORIDEA-S Medication Solutions4a2d814b-93a1-4487-b789-dbafe9f0ffd32026-03-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEdirect rxc33e24e9-0441-6b94-e053-2a95a90a9c682026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
glyburide-metformin hydrochlorideGLYBURIDE-METFORMIN HYDROCHLORIDEA-S Medication Solutionsf43c087a-7135-4a79-8463-fe5e9319da912026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutions75b25738-31e6-4b58-9d2b-f4a1ab4ab0902026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin Hydrochloride Oral SolutionMETFORMIN HYDROCHLORIDEBionpharma Inc.,3ab005d4-bc99-4fdb-e063-6394a90a51242026-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
JardianceEMPAGLIFLOZINCardinal Health 107, LLC5777b8a8-ada6-4950-8548-43a1de11f0752026-02-17Warnings, Adverse reactionsExact identifier
unii: HDC1R2M35U
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEMethod Pharmaceuticals, LLC.4aa880a4-7ec0-9155-e063-6394a90a8f3e2026-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEA-S Medication Solutionsd87dade1-55fe-4e77-91b9-b642022a2b8a2026-02-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutions239834b0-121a-4903-b3ee-90bb4db4753b2026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutions5f2023d2-05ae-489d-9e18-fb75057496bc2026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions1d7556eb-82b4-4085-b0b1-dc061b216feb2026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
JardianceEMPAGLIFLOZINBoehringer Ingelheim Pharmaceuticals, Inc.faf3dd6a-9cd0-39c2-0d2e-232cb3f675652026-01-30Warnings, Adverse reactionsExact identifier
unii: HDC1R2M35U
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEQuallent Pharmaceuticals Health LLC6864ff5a-7512-4a4f-ad26-b2b9c58434142026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions8c248958-6c01-455e-89f5-959facb272ed2026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions192970d3-826a-4b69-a525-9742794dc19c2026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Incdfac4d9c-2f20-417c-a1be-4f1c2738f3512026-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
glyburide-metformin hydrochlorideGLYBURIDE-METFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.a0ff8ee6-0da8-40f8-b5b0-a7b334e1a15f2026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC273d86b0-9d30-48c9-8918-c5e1ececa9512026-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
GlyxambiEMPAGLIFLOZIN AND LINAGLIPTINBoehringer Ingelheim Pharmaceuticals, Inc.ddbab689-f76c-488c-9613-4168d41dd7302026-01-20Warnings, Adverse reactionsExact identifier
unii: HDC1R2M35U
unii: 3X29ZEJ4R2
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.64650d2c-2bec-4470-b250-29d01caa1ebe2026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E

Reported adverse events (FAERS/openFDA)#

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