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 9 of 19 · 370 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAvPAKd9bac244-1725-5bf3-e053-2a95a90ac8232026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAvPAKde09f7a1-1e9f-60f4-e053-2a95a90a93d82026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
ZITUVIMET XRSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Lifesciences Limited4bade493-499e-434a-97a0-26ca689176232026-01-05Exact identifier
unii: 786Z46389E
Metformin hydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LP3ba957ea-28ed-4a61-a318-98064ea4944d2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENorthwind Health Company, LLCab80521b-5014-cc2a-e053-2a95a90a20032026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENorthwind Health Company, LLCf31c08fc-cda1-349c-e053-2a95a90aba152026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENorthwind Health Company, LLCdae7b1c1-7ff1-883c-e053-2a95a90a1a2b2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDENorthwind Health Company, LLCadb751e0-19f6-3f41-e053-2a95a90a2df82026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENorthwind Health Company, LLCf2a27d7a-ade4-421f-e053-2a95a90a01a92026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDENorthwind Health Company, LLC07d8a69f-30d9-7511-e063-6394a90a95ca2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENorthwind Health Company, LLC0178b9dd-bafa-9e81-e063-6294a90a88b02026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENorthwind Health Company, LLCf5ef117c-27ff-c21e-e053-2995a90ae1452026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENorthwind Health Company, LLCdb113f46-6fac-9005-e053-2995a90a017a2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDENorthwind Health Company, LLC4e5a19c6-6ac6-ffc0-e063-6394a90a98272026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEMicro Labs Limitedcc070735-5e8d-4bb3-9caa-e84d29bb89432025-12-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAscend Laboratories, LLC0ff1ba75-3c86-4baf-a6b1-1bb8838398662025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.b63bfafa-db4c-4fb8-84cd-ff73a5e7d3202025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
glyburide-metformin hydrochlorideGLYBURIDE-METFORMIN HYDROCHLORIDEA-S Medication Solutionsfaa19e1b-2782-4bf1-a93f-84755f7aa53f2025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Glipizide and metformin hclGLIPIZIDE AND METFORMIN HCLChartwell RX, LLCac018f64-fd9d-4b3c-b0ac-ca305b8df6352025-12-10Boxed warning, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HClMETFORMIN HCLA-S Medication Solutionsc37b511c-1e33-4941-bd12-df0447a50ca92025-12-06Warnings, Adverse reactionsExact identifier
unii: 786Z46389E

Reported adverse events (FAERS/openFDA)#

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