FDA.reportPublic FDA data

NDC 50090-6452-00 - JARDIANCE

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
50090-6452
Requested NDC
50090-6452-00
Package NDCs from labels
50090-6452-0, 50090-6452-00
Manufacturer
A-S Medication Solutions
Effective date
2023-05-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
JARDIANCE - A-S Medication SolutionsA-S Medication Solutions2023-05-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6452-0JARDIANCE90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6452JARDIANCE (EMPAGLIFLOZIN) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20230504_1782b947-4a72-4feb-a488-1469d9af82bd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6452-0EA - Each50090-6452b34d114a-6fcb-44e3-89fe-d8bb92df101b12023-06-06

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 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JardianceEMPAGLIFLOZINRedpharm Drug59ed43d9-b4e0-72a2-e063-6394a90a327d2026-08-26Warnings, Adverse reactionsExact identifier
application number: NDA204629
rxcui: 1545666
rxcui: 1545668
unii: HDC1R2M35U
SynjardyEMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEBoehringer Ingelheim Pharmaceuticals, Inc.0fdd0255-0055-65f3-b2c0-db8fbb87beae2026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: HDC1R2M35U
Trijardy XREMPAGLIFLOZIN, LINAGLIPTIN, METFORMIN HYDROCHLORIDEBoehringer Ingelheim Pharmaceuticals, Inc.71873567-9594-452a-bb92-34a129adecac2026-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: HDC1R2M35U
Synjardy XREMPAGLIFLOZIN, METFORMIN HYDROCHLORIDEBoehringer Ingelheim Pharmaceuticals, Inc.8006ba29-ee3a-f852-a9bb-c8ec9b41cf662026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: HDC1R2M35U
JardianceEMPAGLIFLOZINAphena Pharma Solutions - Tennessee, LLC334f1b3d-5670-6685-e063-6294a90a7e472026-06-17Warnings, Adverse reactionsExact identifier
application number: NDA204629
rxcui: 1545664
rxcui: 1545658
unii: HDC1R2M35U
JardianceEMPAGLIFLOZINCardinal Health 107, LLC5777b8a8-ada6-4950-8548-43a1de11f0752026-02-17Warnings, Adverse reactionsExact identifier
application number: NDA204629
rxcui: 1545666
rxcui: 1545668
rxcui: 1545664
rxcui: 1545658
unii: HDC1R2M35U
JardianceEMPAGLIFLOZINBoehringer Ingelheim Pharmaceuticals, Inc.faf3dd6a-9cd0-39c2-0d2e-232cb3f675652026-01-30Warnings, Adverse reactionsExact identifier
application number: NDA204629
ndc (product): 0597-0152
rxcui: 1545666
rxcui: 1545668
rxcui: 1545664
rxcui: 1545658
spl id: 09daa78d-f417-436c-a29e-029c015ca6d6
spl set id: faf3dd6a-9cd0-39c2-0d2e-232cb3f67565
unii: HDC1R2M35U
GlyxambiEMPAGLIFLOZIN AND LINAGLIPTINBoehringer Ingelheim Pharmaceuticals, Inc.ddbab689-f76c-488c-9613-4168d41dd7302026-01-20Warnings, Adverse reactionsExact identifier
unii: HDC1R2M35U
JardianceEMPAGLIFLOZINAphena Pharma Solutions - Tennessee, LLC8b6261f6-4bdc-462e-8af1-4064664c62f32025-10-27Warnings, Adverse reactionsExact identifier
application number: NDA204629
rxcui: 1545666
rxcui: 1545668
unii: HDC1R2M35U
JardianceEMPAGLIFLOZINA-S Medication Solutionsa77214ca-572e-485e-aae9-f7950187e5fb2023-08-08Warnings, Adverse reactionsExact identifier
application number: NDA204629
rxcui: 1545666
rxcui: 1545668
unii: HDC1R2M35U
JARDIANCEEMPAGLIFLOZINA-S Medication Solutions942a82a4-cbbd-4e44-9965-8d03f767912b2023-07-24Warnings, Adverse reactionsExact identifier
application number: NDA204629
rxcui: 1545664
rxcui: 1545658
unii: HDC1R2M35U
JARDIANCEEMPAGLIFLOZINA-S Medication Solutions1782b947-4a72-4feb-a488-1469d9af82bd2023-05-03Warnings, Adverse reactionsExact identifier
application number: NDA204629
ndc (package): 50090-6452-0
ndc (product): 50090-6452
ndc11 (package): 50090645200
rxcui: 1545664
rxcui: 1545658
spl id: 46a68ec5-d52b-46dd-920f-38eff4165301
spl set id: 1782b947-4a72-4feb-a488-1469d9af82bd
unii: HDC1R2M35U
JARDIANCEEMPAGLIFLOZINA-S Medication Solutionsf2b41c77-0abb-40ee-8578-86a748d0e19e2023-05-03Warnings, Adverse reactionsExact identifier
application number: NDA204629
rxcui: 1545666
rxcui: 1545668
unii: HDC1R2M35U

Reported adverse events (FAERS/openFDA)#

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