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 16 of 19 · 370 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetforminMETFORMIN ER 500 MGAphena Pharma Solutions - Tennessee, LLC5c10eaa2-d6ba-446a-8f16-f5a8ca7223d72024-06-10Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC1a047fc0-196e-79af-e063-6394a90a1e0d2024-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEBryant Ranch Prepack8f2951ab-20c3-4216-b250-4c6a62d322032024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions1c046303-993c-4111-ac9a-40a0d97ca6a22024-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions1a7f7ef3-a94b-4ff6-a9f2-f5de4a99c7f62024-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsafb183f6-a13c-4f00-82d5-9fe336173d342024-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepackd5dbf0d9-9673-4aae-9e28-da9b90bac0382024-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsc2783b59-7b20-4d4c-a3ca-03ed60dcf2c32024-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions2be73d5e-7682-4ad3-831b-8c1ea73e38de2024-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LP928ef685-80cb-42a9-a155-3c21c9b1dd672024-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.1182bf60-3578-a0ed-e063-6394a90aa50f2024-02-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepack9c33414b-5dbb-4ce9-910b-9480d45e50ee2024-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepackf9e78e0f-6a0a-4db3-bc09-5500748f9c842024-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
TradjentaLINAGLIPTINA-S Medication Solutionsb1da67d4-51e0-41b7-9fe1-7f38c0d1baa12024-01-22Warnings, Adverse reactionsExact identifier
unii: 3X29ZEJ4R2
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions3c607f04-d36f-4cf8-9cc9-7f2af08b40982024-01-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutions7cc82387-8bb0-4bee-9967-cb13eab1d8012024-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCb090b18b-b53c-4c92-892f-d11551cfedc32023-12-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC38687872-ca68-4965-b317-637c25ba041e2023-11-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
alogliptin and metformin hydrochlorideALOGLIPTIN AND METFORMIN HYDROCHLORIDEA-S Medication Solutions9112d6b9-4771-4194-886d-7db887470bcc2023-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEA-S Medication Solutionsd0bc43a4-301f-4002-9b58-bd81dddf27902023-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E

Reported adverse events (FAERS/openFDA)#

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