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 6 of 19 · 370 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication Solutions4f5389d2-dbcf-4fcb-9048-05953eb1fb052026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Dapagliflozin and Metformin HydrochlorideDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEGolden State Medical Supply, Inc.54027b70-53e7-3710-e063-6394a90aa04c2026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepack4d245bc3-0add-4651-b441-86b93c5ac6812026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Glipizide and Metformin HydrochlorideGLIPIZIDE AND METFORMIN HYDROCHLORIDETeva Pharmaceuticals USA, Inc.03d9ce02-0559-494c-a53d-de9b9a64b6062026-06-11Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
glyburide and metformin hydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.2239742b-74e1-4bc2-b5a8-15c4758d6f7b2026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDECoupler LLC53e950f5-c58f-78e3-e063-6294a90a53e92026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETSQingdao BAHEAL Pharmaceutical Co. Ltd.7ea6e623-4073-4671-e053-2a91aa0a3ca32026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
glyburide and metformin hydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEZydus Lifesciences Limiteddf752bd4-e197-40a4-a01b-d48ba2c105162026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEMARKSANS PHARMA LIMITEDb8004451-7b26-425b-b5ea-cbb1b08e30e32026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEQPharma Inc5269e91f-7e93-9405-e063-6294a90a32172026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEQPharma Inc53bde438-4277-f418-e063-6394a90a5ea22026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEMylan Pharmaceuticals Inc.4f70f907-08d5-4c2e-a4be-32c6124faa7b2026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HClMETFORMIN HCLProficient Rx LPd2c927eb-12bf-4c7d-9ef5-0036b2dd8c292026-06-01Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.d1d7204a-7e8a-4f76-bf9f-3e798c2632ba2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEWestminster Pharmaceuticals, LLC836f3647-bfef-40d1-b475-c0d240241a672026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepack1e7ab8da-4ece-499c-b0fb-34e37d991c1c2026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEGolden State Medical Supply, Inc.1cb2b2be-595c-4e72-8d2c-c1edc7f856822026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HClMETFORMIN HCLNorthwind Health Company, LLC13b1e35f-d047-8ddc-e063-6394a90a24dd2026-05-14Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin hydrochlorideMETFORMIN HYDROCHLORIDEUNICHEM PHARMACEUTICALS (USA), INC.93c8deae-3103-4cbf-a5d1-fe0d37e76df82026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.a58ff524-e975-4d51-a896-e869f8ea66242026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E

Reported adverse events (FAERS/openFDA)#

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