FDA.reportPublic FDA data

NDC 68788-8089-06 - 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
68788-8089
Requested NDC
68788-8089-06
Package NDCs from labels
68788-8089-2, 68788-8089-3, 68788-8089-6, 68788-8089-9, 68788-8089-1, 68788-8089-06
Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2025-01-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Aripiprazole - Preferred Pharmaceuticals Inc.Preferred Pharmaceuticals Inc.2025-01-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8089-1Aripiprazole100 in 1 BOTTLETABLET1005
68788-8089-2Aripiprazole20 in 1 BOTTLETABLET205
68788-8089-3Aripiprazole30 in 1 BOTTLETABLET305
68788-8089-6Aripiprazole60 in 1 BOTTLETABLET605
68788-8089-9Aripiprazole90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8089ARIPIPRAZOLE TABLET [PREFERRED PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 5 package rows20250205_34127431-6ad7-402f-bc22-1429c55d921c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8089-1EA - Each68788-80895e98e677-5d6e-4bea-9cfb-58d8f2ae121912021-11-09
68788-8089-2EA - Each68788-808958188d0b-ea51-4bc7-8d41-87ccf961352612021-11-09
68788-8089-3EA - Each68788-80897cc2a14f-eb8c-4226-a407-d3d856728d7f12021-11-09
68788-8089-6EA - Each68788-8089c02e68d6-81a1-42c5-89a0-9c1af205639812021-11-09
68788-8089-9EA - Each68788-8089736a2d53-09bd-49c5-8c45-ac892673d20c12021-11-09

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 1 of 7 · 126 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.b72c0cff-9f4d-42e2-b884-d06dea3e63782026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349490
unii: 82VFR53I78
aripiprazoleARIPIPRAZOLEApotex Corp.14910dae-da81-3d73-d0a4-e98d13917c692026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.1d593ada-256d-4dec-9a26-2a6a67d972052026-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207105
rxcui: 349547
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.bc3fde41-2f24-44e2-815d-15fe55bd68b32026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207105
rxcui: 349490
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.506fa28f-6f98-4632-bce8-72a9cb507c902026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207105
rxcui: 349553
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.f713c38e-cc49-4243-96b9-32d5dbbcf9cb2026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207105
rxcui: 349545
unii: 82VFR53I78
aripiprazoleARIPIPRAZOLEREMEDYREPACK INC.1ad7d167-1235-4c5c-8159-da8972240ede2026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 602964
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEAurobindo Pharma Limited7bf7d35e-46a1-4e8f-aeb5-8a93223a4abc2026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349547
rxcui: 349553
rxcui: 602964
rxcui: 349545
rxcui: 349490
rxcui: 402131
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.119e3387-39a2-4fe5-904b-c2d008425c0a2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349545
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLE ORALLY DISINTEGRATINGDr. Reddy's Laboratories Inc394ea4a4-3991-4f98-b38f-56e9335d66b32026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.99747897-22fe-4bee-9942-6349c0c8f6b02026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 402131
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEAurobindo Pharma Limited476b92f3-cf7b-4c09-ac67-6ed35e6811d52026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLE ORALATLANTIC BIOLOGICALS CORP.042b725c-1c17-4cfb-80b2-c841226d795e2026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLECoupler LLC56439ef6-a07e-34c9-e063-6294a90a77c32026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349545
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLECoupler LLC55f3a705-9412-0f88-e063-6294a90a2b532026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207105
rxcui: 349490
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLECoupler LLC55f446b0-caa2-aca8-e063-6294a90af4412026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207105
rxcui: 602964
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.a1191a90-eb83-4a59-948c-b9774d2c83a52026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 402131
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEBryant Ranch Prepack69af5199-f872-4298-8d09-035e2127d3d42026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349545
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEUnit Dose Solutions, Inc.535f4fbd-b6a7-7611-e063-6294a90a5c432026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 402131
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLECoupler LLC52cc86ba-2c4f-1aba-e063-6294a90a844e2026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349553
unii: 82VFR53I78

Reported adverse events (FAERS/openFDA)#

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