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 2 of 7 · 123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AripiprazoleARIPIPRAZOLECoupler LLC52bbfc8f-fa17-839e-e063-6394a90a63162026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207105
rxcui: 402131
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEBryant Ranch Prepackc092a736-16e2-4dd0-8769-cb766a62f4d92026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 602964
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLECoupler LLC512874e6-6d00-2623-e063-6394a90aa4bc2026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349490
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLECoupler LLC50214c47-2ea3-b373-e063-6394a90aad232026-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207105
rxcui: 349545
unii: 82VFR53I78
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.6f580e75-61ab-4c7b-bb3f-f027a9603f842026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207105
rxcui: 602964
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.433cdc7d-465a-4ad4-bd84-cabd37e15f512026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207105
ndc (package): 70518-2897-3
ndc (package): 70518-2897-2
ndc (package): 70518-2897-1
ndc (package): 70518-2897-0
ndc (product): 70518-2897
ndc11 (package): 70518289701
rxcui: 402131
spl id: 4d65bd57-682e-56be-e063-6294a90a2468
spl set id: 433cdc7d-465a-4ad4-bd84-cabd37e15f51
unii: 82VFR53I78
aripiprazoleARIPIPRAZOLEMajor Pharmaceuticals969c17aa-6abc-413c-8561-f1ad8fdde3e52026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 402131
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEPreferred Pharmaceuticals, Inc.36fb0c13-dfae-46ac-bb71-0b53fe5649f42026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 402131
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEPreferred Pharmaceuticals Inc.02a4af27-c83c-4166-950c-7a1cb12d198d2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349490
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEBryant Ranch Prepackff8dc838-ca1a-49d3-8938-5ae645574a752026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207105
rxcui: 349545
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.2bc00231-c2e7-4b9d-93a1-fb796fd8d5912026-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 602964
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEBryant Ranch Prepack1e8d889e-126b-4627-a2cc-34f2d35a5d672026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207105
rxcui: 349545
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEBryant Ranch Prepack1ef9e44f-5672-47c2-97e9-286e1b84417d2026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207105
rxcui: 349490
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEBryant Ranch Prepack4bda6f17-d87c-4009-b329-99275c56106f2026-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207105
rxcui: 349553
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEBryant Ranch Prepackfb40b669-4e37-4087-8fb1-3ac1405436022026-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207105
rxcui: 402131
unii: 82VFR53I78
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
AripiprazoleARIPIPRAZOLEA-S Medication Solutions554db933-aa80-4685-bcd5-58c84571c19c2026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207105
rxcui: 349545
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLECoupler LLC47430dfa-9377-6c31-e063-6394a90a86a92025-12-31Boxed 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.