FDA.reportPublic FDA data

NDC 70518-2897-01 - 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
70518-2897
Requested NDC
70518-2897-01
Package NDCs from labels
70518-2897-0, 70518-2897-1, 70518-2897-2, 70518-2897-3, 70518-2897-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-03-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Aripiprazole - REMEDYREPACK INC.REMEDYREPACK INC.2026-03-19HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2022-02-08These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002
2022-02-08These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002
2022-02-08These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002
2022-02-08These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002
2022-01-28These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002
2022-01-28These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002
2022-01-28These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002
2022-01-28These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2897-0Aripiprazole30 in 1 BLISTER PACKTABLET3012
70518-2897-1Aripiprazole30 in 1 BOTTLE, PLASTICTABLET3012
70518-2897-2Aripiprazole180 in 1 BOTTLE, PLASTICTABLET18012
70518-2897-3Aripiprazole30 in 1 BLISTER PACKTABLET3012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2897ARIPIPRAZOLE TABLET [REMEDYREPACK INC.]8Current NDC, Legacy NDC, 4 package rows20250507_433cdc7d-465a-4ad4-bd84-cabd37e15f51.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2897-0EA - Each70518-2897c0f67b6c-95df-4fe0-8293-dc33f5eb17ba12026-01-08

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 7 · 123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AripiprazoleARIPIPRAZOLEPreferred Pharmaceuticals, Inc.4894031e-639e-49d8-927a-76d684bf66552025-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207105
rxcui: 602964
unii: 82VFR53I78
aripiprazoleARIPIPRAZOLEPreferred Pharmaceuticals Inc.faa3032b-d9a1-45dd-88be-abb432223f132025-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349553
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEPrefferred Pharmaceuticals Inc.fbb3ac69-8dba-42df-8d6d-ef3d79241edb2025-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207105
rxcui: 349545
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLENuCare Pharmaceuticals, Inc.27874fe2-3fd6-002d-e063-6294a90a4cd72024-11-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207105
rxcui: 602964
unii: 82VFR53I78
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
AripiprazoleARIPIPRAZOLEA-S Medication Solutionsbf3cf835-4c4e-47cb-be9c-bcb7c2e11cbe2024-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207105
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
AripiprazoleARIPIPRAZOLEBryant Ranch Prepackee33be35-abc8-453f-98e9-7974026b7eb02024-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207105
rxcui: 602964
unii: 82VFR53I78
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
rxcui: 349545
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEA-S Medication Solutions3ab6af7c-3169-46bf-bd3f-697c81bbcede2024-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207105
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

Reported adverse events (FAERS/openFDA)#

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