FDA.reportPublic FDA data

NDC 70518-2820-2 - 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
70518-2820
Requested NDC
70518-2820-2
Package NDCs from labels
70518-2820-0, 70518-2820-2, 70518-2820-1, 70518-2820-3, 70518-2820-4
Manufacturer
REMEDYREPACK INC.
Effective date
2026-07-29
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.2026-07-29HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
70518-2820-02022-02-04These 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
70518-2820-02022-02-04These 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
70518-2820-02022-02-04These 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
70518-2820-12022-02-04These 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
70518-2820-12022-02-04These 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
70518-2820-12022-02-04These 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
70518-2820-02022-01-28These 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
70518-2820-02022-01-28These 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
70518-2820-02022-01-28These 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
70518-2820-12022-01-28These 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
70518-2820-12022-01-28These 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
70518-2820-12022-01-28These 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
70518-2820-0Aripiprazole30 in 1 BLISTER PACKTABLET3015
70518-2820-1Aripiprazole30 in 1 BOXTABLET3015
70518-2820-2Aripiprazole1 in 1 POUCHTABLET115
70518-2820-3Aripiprazole30 in 1 BLISTER PACKTABLET3015
70518-2820-4Aripiprazole30 in 1 BOTTLE, PLASTICTABLET3015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2820ARIPIPRAZOLE TABLET [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 5 package rows20250423_f713c38e-cc49-4243-96b9-32d5dbbcf9cb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2820-0EA - Each70518-28207bf8009e-cec6-4fda-8bfb-74dc1c8408bb12023-01-09
70518-2820-1EA - Each70518-28201cc6798f-608f-4513-8a4b-3406aa3d0a5412023-01-09
70518-2820-2EA - Each70518-282015b4205d-2ea7-49da-9924-715cd3438bb612023-01-09

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 7 of 10 · 183 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AripiprazoleARIPIPRAZOLEUnichem Pharmaceuticals (USA), Inc.349b8a7b-5ada-4f5c-a269-a86806c6b5202025-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349547
rxcui: 349553
rxcui: 602964
rxcui: 349545
rxcui: 349490
rxcui: 402131
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLE ORALCamber Pharmaceuticals, Inc.da47ad78-e62c-4bf3-9b53-d8cc246bcfb62025-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEAlembic Pharmaceuticals Inc.de2dc5fd-ecb4-4445-9cfb-10e64fe3269d2025-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
CalamineFERRIC OXIDE REDPreferred Pharmaceuticals Inc.326f3d80-c1bf-4cf0-a662-58e02ed7ee672025-02-12Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
OPIPZAARIPIPRAZOLECarwin Pharmaceutical Associates, LLCb47ede68-8942-4432-af7e-57afc14b2ba42025-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.c040bd1d-45b7-49f2-93ea-aed7220b30ac2025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349547
rxcui: 349553
rxcui: 602964
rxcui: 349545
rxcui: 349490
rxcui: 402131
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLELannett Company, Inc.e7292c4c-e332-4ed4-9086-f130d223b6ae2025-01-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEDirect_Rxf823bc23-27f3-2397-e053-6294a90a365a2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 402131
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEDirect_Rxf81d9b82-5879-3c0a-e053-6294a90ac23e2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349553
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEDirect_Rxfacdb9a9-612f-e59a-e053-6394a90a1fa72025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207105
rxcui: 602964
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEDirect_Rxfcea91c3-e428-8991-e053-6394a90a099d2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207105
rxcui: 349545
unii: 82VFR53I78
Prunus IronPRUNUS IRONUriel Pharmacy Inc.091be588-b62e-4919-8e9e-3edb9792d3192025-01-22WarningsExact identifier
unii: 1K09F3G675
AripiprazoleARIPIPRAZOLEBionpharma Inc.720bc395-777d-4e5d-9571-aad5827dbf6d2025-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEViona Pharmaceuticals Inc.73c5e380-b7b1-4362-a827-71881574ff482025-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
Ferrum Silicicum UrticaFERRUM SILICICUM URTICAUriel Pharmacy Inc.09829ac4-c074-7315-e063-6394a90adf592025-01-07WarningsExact identifier
unii: 1K09F3G675
AripiprazoleARIPIPRAZOLEPreferred Pharmaceuticals Inc.34127431-6ad7-402f-bc22-1429c55d921c2025-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207105
rxcui: 402131
unii: 82VFR53I78
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

Reported adverse events (FAERS/openFDA)#

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