FDA.reportPublic FDA data

NDC 59368-381-01 - Jentadueto 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
59368-381
Requested NDC
59368-381-01
Package NDCs from labels
59368-381-01
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
Jentadueto 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 14 of 18 · 360 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetforminMETFORMIN ER 750 MGBryant Ranch Prepackf1058475-1318-49a0-89ce-da06692b0e5b2024-11-25Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions565610b8-a9a0-4e5e-866d-81d9501a817d2024-11-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions2d2ebf52-3d5e-4fad-b7f7-c9280957574c2024-11-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin hydrochlorideMETFORMIN HYDROCHLORIDEOceanside Pharmaceuticals74d32a8a-c4c2-4dbb-b376-eea3f8fa64d72024-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
MetforminMETFORMIN ER 500 MGProficient Rx LP92855c8d-59be-458b-97f1-2ff11b9bf6b02024-11-01Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
MetforminMETFORMIN ER 750 MGA-S Medication Solutions9e3791fb-9a34-4982-8164-0502fa398b012024-10-22Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
MetforminMETFORMIN ER 750 MGA-S Medication Solutions953404a4-0f03-42f1-8136-43238dad11f42024-10-22Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsc2bbaa0c-5b05-4335-882f-14f1b443edd72024-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions54ca16e6-1213-4877-8ace-477c764c8e762024-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HClMETFORMIN HCLNuCare Pharmaceuticals, Inc.242256af-c587-060a-e063-6294a90a68cc2024-10-10Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin hydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC242538d7-fb79-4df6-e063-6394a90a5b962024-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAmerican Health Packagingdd54d30b-9390-4e5a-bf62-fbf18b91e4cd2024-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.0710e208-5b2c-3c72-e063-6394a90a4dac2024-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HClMETFORMIN HCLAdvanced Rx of Tennessee, LLC21b76183-af30-e06f-e063-6394a90a96532024-09-23Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs23aa0072-365c-4d13-9aa7-ae23f7e00ee42024-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Sitagliptin and Metformin HydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Pharmaceuticals USA Inc.d3a728a0-decb-4340-8ee4-c5e27c13eb192024-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEWestminster Pharmaceuticals, LLC583dac53-65e7-4710-912a-ecd89d07ad032024-08-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepacked6e6f87-ddd7-4c9d-a263-47154d3a94782024-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
MetforminMETFORMIN ER 500 MGBryant Ranch Prepack1f823d36-c7a6-4cf8-b6f1-52b7a51c8fc42024-08-26Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Sitagliptin and Metformin HydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Lifesciences Limiteda07fa1d9-7171-4f2a-ab34-f8fa410364a62024-08-24Exact identifier
unii: 786Z46389E

Reported adverse events (FAERS/openFDA)#

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