FDA.reportPublic FDA data

NDC 50090-4383-00 - Tradjenta

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
50090-4383
Requested NDC
50090-4383-00
Package NDCs from labels
50090-4383-0, 50090-4383-00
Manufacturer
A-S Medication Solutions
Effective date
2024-01-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tradjenta - A-S Medication SolutionsA-S Medication Solutions2024-01-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4383-0Tradjenta90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4383TRADJENTA (LINAGLIPTIN) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 1 package rows20240123_b1da67d4-51e0-41b7-9fe1-7f38c0d1baa1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4383-0EA - Each50090-438328e8e96a-401d-4c26-b44b-81dea898832712022-07-06

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 1 of 1 ยท 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trijardy XREMPAGLIFLOZIN, LINAGLIPTIN, METFORMIN HYDROCHLORIDEBoehringer Ingelheim Pharmaceuticals, Inc.71873567-9594-452a-bb92-34a129adecac2026-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3X29ZEJ4R2
JentaduetoLINAGLIPTIN AND METFORMIN HYDROCHLORIDEBoehringer Ingelheim Pharmaceuticals, Inc.f6dd9b86-0d18-95d4-2bc7-05591bfdd5972026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3X29ZEJ4R2
Jentadueto XRLINAGLIPTIN AND METFORMIN HYDROCHLORIDEBoehringer Ingelheim Pharmaceuticals, Inc.3d02a4d4-d312-80b4-05c4-691b8f0aa7aa2026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3X29ZEJ4R2
GlyxambiEMPAGLIFLOZIN AND LINAGLIPTINBoehringer Ingelheim Pharmaceuticals, Inc.ddbab689-f76c-488c-9613-4168d41dd7302026-01-20Warnings, Adverse reactionsExact identifier
unii: 3X29ZEJ4R2
Linagliptin and metformin hydrochlorideLINAGLIPTIN AND METFORMIN HYDROCHLORIDENovadoz Pharmaceuticals LLC5cff87ef-97f9-4e3c-9e06-fd257f3cb3fb2025-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3X29ZEJ4R2
TradjentaLINAGLIPTINCardinal Health 107, LLCdfe327e8-f6ab-41e5-bdef-d520118cd83a2025-08-27Warnings, Adverse reactionsExact identifier
application number: NDA201280
rxcui: 1100702
rxcui: 1100706
unii: 3X29ZEJ4R2
TradjentaLINAGLIPTINBoehringer Ingelheim Pharmaceuticals, Inc.c797ea5c-cab7-494b-9044-27eba0cfe40f2025-03-21Warnings, Adverse reactionsExact identifier
application number: NDA201280
ndc (product): 0597-0140
rxcui: 1100702
rxcui: 1100706
spl id: 80d5d700-e711-462e-b291-3684a78d00b8
spl set id: c797ea5c-cab7-494b-9044-27eba0cfe40f
unii: 3X29ZEJ4R2
TradjentaLINAGLIPTINA-S Medication Solutionsb1da67d4-51e0-41b7-9fe1-7f38c0d1baa12024-01-22Warnings, Adverse reactionsExact identifier
application number: NDA201280
ndc (package): 50090-4383-0
ndc (product): 50090-4383
ndc11 (package): 50090438300
rxcui: 1100702
rxcui: 1100706
spl id: 706b12b0-f37f-4e9c-9776-038d78f4b9de
spl set id: b1da67d4-51e0-41b7-9fe1-7f38c0d1baa1
unii: 3X29ZEJ4R2

Reported adverse events (FAERS/openFDA)#

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