FDA.reportPublic FDA data

NDC 59368-381 - 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
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 18 of 19 · 370 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
36d616ed-d035-ce7c-e063-6394a90aa44a36d616e1-c256-ce92-e063-6394a90ab94b2023-01-01Exact identifier
spl id: 36d616ed-d035-ce7c-e063-6394a90aa44a
spl set id: 36d616e1-c256-ce92-e063-6394a90ab94b
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC34aa1761-d16f-4bfc-b7fa-bf1b0387e8a32022-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCd0bee456-c8cd-46a1-acb3-5313a8cddd302022-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LP474e2900-43bf-4ebe-9d29-4a7adb8a94292022-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC6b8824c0-ece0-4b15-ba71-e893d6d2bfdf2022-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HClMETFORMIN HCLProficient Rx LP53361a39-cb69-483b-a4be-3a4753bf1ba62022-06-01Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDESolco Healthcare US, LLC.1016cad7-2198-483c-893b-e25fd397a2262022-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LPd51f3618-4166-4925-8994-968a653ebc462022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LPd80aa4af-a8ce-4cae-b71c-05e1de8295512022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LP5f243894-bda3-4fa9-97e4-209dcb389dee2022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETSScieGen Pharmaceuticals, Inc.16dc4008-7b5e-4c6d-9bc8-8db96be911a12022-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LP738402d6-3700-46b2-a90c-2e8f2c354a392022-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin hydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCc789254c-be70-4d25-8c6c-b284b01eb5132022-02-22Boxed warning, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin hydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC5e5fb10b-b874-43c9-9424-9080b9e866c82022-02-22Boxed warning, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC0b843f12-a654-4751-be1f-55e6fce163c92021-12-08WarningsExact identifier
unii: 786Z46389E
Metformin HClMETFORMIN HCLBryant Ranch Prepack1f8833f9-1232-4aa7-a0d4-04a9f87dc2f02021-11-01Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC1e298db3-439e-4e91-8f9e-01c3cdc4d5522021-08-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC4d89a4ab-6cdd-4c39-92f9-a137fa27a0702021-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETSScieGen Pharmaceuticals, Inc.1452fbb1-e591-4a51-9f83-8a8a6a780b522021-06-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC439bb230-94d8-4522-ad79-5cce5fad965b2021-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E

Reported adverse events (FAERS/openFDA)#

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