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 19 of 19 · 370 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepack9632456f-57c2-444b-9f43-d9ca862681fe2021-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEACI Healthcare USA, Inc.e18b60f9-721e-4db6-9f61-d3437e18faf22020-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEEpic Pharma, LLC8c1848f9-c113-4552-b6ef-715e72630ad92019-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LP6f6118c1-cecc-4d7b-9965-7b114a1ad56b2019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Glipizide and Metformin HClGLIPIZIDE AND METFORMIN HCLProficient Rx LPbe4d2552-c964-4d09-ba7a-0d94320f968c2019-10-01Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEPuraCap Laboratories LLC dba Blu Pharmaceuticals5c2581e3-2b30-4da5-8bed-228173ca20d22019-01-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
RiometMETFORMIN HYDROCHLORIDESun Pharmaceutical Industries, Inc.05d4df4b-dfe8-4828-b423-a3d4f2c4114a2018-12-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAmneal Pharmaceuticals LLCc01a79e0-f2b7-4d99-857e-bda7f24fe3192018-08-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEMetcure Pharmaceuticals, Inc.5df6adc9-79fd-66ef-e053-2991aa0a75ce2018-01-22Boxed warning, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HClMETFORMIN HCLAscend Laboratories, LLC2d98aea3-35ba-447a-b88f-a5a20b612b2f2017-02-07Warnings, Adverse reactionsExact identifier
unii: 786Z46389E

Reported adverse events (FAERS/openFDA)#

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