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 5 of 10 · 183 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYHY-VEE, INC415ecfe9-3145-f23e-e063-6394a90adfd82025-11-17WarningsExact identifier
unii: 1K09F3G675
Au Kah Chuen FugicalCALAMINE AND DIPHENHYDRAMINE HYDROCHLORIDZhejiang Dingtai Pharmaceutical Co., Ltd5b4add17-6c3d-4093-826a-2edb41c1d1db2025-11-10WarningsExact identifier
unii: 1K09F3G675
FARGELIN HEMORRHOIDALCALAMINE, PETROLATUM AND PHENYLEPHRINE HYDROCHLORIDEMADISON ONE ACME INC6844ad63-512d-496a-9458-011894185b0d2025-11-10WarningsExact identifier
unii: 1K09F3G675
Calamine PlusCALAMINE PLUS PRAMOXINE HCLChain Drug Marketing Association Inc1a3f8819-58cf-8923-e063-6394a90a37af2025-11-06WarningsExact identifier
unii: 1K09F3G675
Calamine Plus Pramoxine HClCALAMINE PLUS NO TOUCH SPRAYPremier Brands of America Inc.36481d67-2346-470b-e063-6294a90aae992025-11-03WarningsExact identifier
unii: 1K09F3G675
Calamine PlusCALAMINE PLUS PRAMOXINE HCLAmerisourceBergen Drug Corporationf161e151-4fab-2fbc-e053-2a95a90a54372025-10-30WarningsExact identifier
unii: 1K09F3G675
REMEDY Calazime Skin ProtectantCALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDEMedline Industries, LP1295cfcc-5b61-481b-964b-f53ffd0cb58e2025-10-30WarningsExact identifier
unii: 1K09F3G675
Calamine PlusCALAMINE PLUS PRAMOXINE HCLMeijer Distribution Inc.03c46823-0b1f-4101-e063-6294a90aaf942025-10-30WarningsExact identifier
unii: 1K09F3G675
Aveeno Anti-Itch ConcentratedZINC OXIDE, FERRIC OXIDE RED, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC07f4d4d0-9cee-46c3-bc71-2024abd31c9e2025-10-29WarningsExact identifier
unii: 1K09F3G675
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYPremier Brands of America, Inc.d3452573-f91f-f157-e053-2a95a90a1ad82025-10-27WarningsExact identifier
unii: 1K09F3G675
AripiprazoleARIPIPRAZOLEDr.Reddys Laboratories Inc178f09f0-e08e-452b-b817-717c5c49e1102025-10-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349547
rxcui: 349553
rxcui: 602964
rxcui: 349545
rxcui: 349490
rxcui: 402131
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLENuCare Pharmaceuticals, Inc.414b7fd2-6a63-af39-e063-6394a90a00b82025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349545
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEPD-Rx Pharmaceuticals, Inc.0cf6655e-d59a-4ebd-9698-195cad2adbd52025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 402131
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEAjanta Pharma USA Inc.d0f910b5-adef-4a93-9369-70f1ed5415032025-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA206174
ndc (product): 27241-053
rxcui: 349547
rxcui: 349553
rxcui: 602964
rxcui: 349545
rxcui: 349490
rxcui: 402131
spl id: 2a724a23-cf45-4d22-90f5-ebe68f9b7ab9
spl set id: d0f910b5-adef-4a93-9369-70f1ed541503
unii: 82VFR53I78
ARIPIPRAZOLEARIPIPRAZOLEAccord Healthcare, Inc.85cc7d25-414b-4b6f-a03a-48af908a16a12025-10-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349547
rxcui: 349553
rxcui: 602964
rxcui: 349545
rxcui: 349490
rxcui: 402131
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEAscend Laboratories, LLCc7040fef-96a7-4429-9a8e-ec3ab17a80192025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349547
rxcui: 349553
rxcui: 602964
rxcui: 349545
rxcui: 349490
rxcui: 402131
unii: 82VFR53I78
PowderTITANIUM DIOXIDEOxygen Development LLC08b52f29-c1a0-c673-e063-6294a90a9a7a2025-09-05WarningsExact identifier
unii: 1K09F3G675
PowderTITANIUM DIOXIDEOxygen Development LLC08b8003f-40be-3380-e063-6294a90a4f6b2025-09-05WarningsExact identifier
unii: 1K09F3G675
AripiprazoleARIPIPRAZOLEAvPAK7df4c83e-13d8-25b1-57eb-08d26ba035652025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349547
rxcui: 349553
rxcui: 602964
rxcui: 349545
rxcui: 349490
rxcui: 402131
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLENuCare Pharmaceuticals, Inc.3cf72cc6-ae43-bfd5-e063-6294a90a18b02025-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 402131
unii: 82VFR53I78

Reported adverse events (FAERS/openFDA)#

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