FDA.reportPublic FDA data

NDC 50090-6409-01 - Aripiprazole

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
50090-6409
Requested NDC
50090-6409-01
Package NDCs from labels
50090-6409-0, 50090-6409-1, 50090-6409-01
Manufacturer
A-S Medication Solutions
Effective date
2024-06-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Aripiprazole - A-S Medication SolutionsA-S Medication Solutions2024-06-05Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6409-0Aripiprazole90 in 1 BOTTLETABLET905
50090-6409-1Aripiprazole30 in 1 BOTTLETABLET305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6409ARIPIPRAZOLE TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, 2 package rows20240606_13339e7f-a8b4-430d-b623-47372de98348.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6409-1EA - Each50090-6409f248e6a6-3892-46fa-8c77-77f8b09bb46e12023-05-05

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 8 of 10 · 183 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AripiprazoleARIPIPRAZOLE ORALLY DISINTEGRATINGScieGen Pharmaceuticals Inc4bcfd5a7-bec7-4426-9314-17daaf715cad2024-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349545
rxcui: 349490
unii: 82VFR53I78
aripiprazoleARIPIPRAZOLEBryant Ranch Prepacke7b6a156-8001-441c-bfd3-bf8987a339e82024-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349553
unii: 82VFR53I78
aripiprazoleARIPIPRAZOLEBryant Ranch Prepackb62837db-1949-4dba-9e2f-714a9f136f5a2024-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349545
unii: 82VFR53I78
aripiprazoleARIPIPRAZOLEBryant Ranch Prepackd130836c-5f1c-4779-ac6c-6350752dc0152024-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349490
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLENCS HealthCare of KY, LLC dba Vangard Labsd8183eaf-0093-4720-b8ed-20e5706975112024-10-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 602964
rxcui: 349545
unii: 82VFR53I78
CaladrylFERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDEBausch Health US, LLC67d4fd42-9fed-4238-9f5a-c9403abbcf202024-10-17WarningsExact identifier
unii: 1K09F3G675
AripiprazoleARIPIPRAZOLEA-S Medication Solutionsbf3cf835-4c4e-47cb-be9c-bcb7c2e11cbe2024-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349553
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEAurobindo Pharma Limitedfcabd777-dcb7-452c-821c-575a5991c90a2024-10-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEVistaPharm, LLC06529caf-698f-41da-81ec-d0ba5ab200d72024-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
CalamineCALAMINE AND ZINC OXIDEStrategic Sourcing Services, LLC22173332-9d09-768c-e063-6394a90a94e12024-09-14WarningsExact identifier
unii: 1K09F3G675
AripiprazoleARIPIPRAZOLEBryant Ranch Prepackee33be35-abc8-453f-98e9-7974026b7eb02024-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 602964
unii: 82VFR53I78
CalamineFERRIC OXIDE REDNuCare Pharmaceuticals,Inc.66e98554-e158-a519-e053-2a91aa0a67832024-06-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
AripiprazoleARIPIPRAZOLEA-S Medication Solutionsc8a94428-b6d2-428b-a3a5-7b983d572fab2024-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349553
unii: 82VFR53I78
aripiprazoleARIPIPRAZOLEA-S Medication Solutionsab3973f3-3db8-4db2-8258-1b21af7b63802024-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 402131
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEA-S Medication Solutions13339e7f-a8b4-430d-b623-47372de983482024-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA206174
ndc (package): 50090-6409-1
ndc (package): 50090-6409-0
ndc (product): 50090-6409
ndc11 (package): 50090640901
rxcui: 349545
spl id: e0dea83a-2ca1-4a83-89d3-c7cf6e5c3123
spl set id: 13339e7f-a8b4-430d-b623-47372de98348
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEA-S Medication Solutions3ab6af7c-3169-46bf-bd3f-697c81bbcede2024-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 402131
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEA-S Medication Solutions89c2cddc-2ae3-4505-adf9-018542c713bf2024-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349553
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEBryant Ranch Prepack3c0109f6-0549-4f91-a259-d9d6d7329b912024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 402131
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEBryant Ranch Prepack6b0c3767-d397-4c7f-b229-083620d9ae6b2024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 602964
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLE ORALNorthStar RxLLC4a0a2f6c-d7bb-48d1-b5ca-066f27f78e412024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78

Reported adverse events (FAERS/openFDA)#

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