FDA.reportPublic FDA data

NDC 67877-431-33 - 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
67877-431
Requested NDC
67877-431-33
Package NDCs from labels
67877-431-03, 67877-431-01, 67877-431-05, 67877-431-33, 67877-431-38, 67877-431-32
Manufacturer
Coupler LLC
Effective date
2026-05-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Aripiprazole - Coupler LLCCoupler LLC2026-05-26HUMAN PRESCRIPTION DRUG LABEL
Aripiprazole - REMEDYREPACK INC.REMEDYREPACK INC.2026-03-19HUMAN PRESCRIPTION DRUG LABEL
Aripiprazole - Bryant Ranch PrepackBryant Ranch Prepack2026-01-27HUMAN PRESCRIPTION DRUG LABEL
Aripiprazole - Ascend Laboratories, LLC | Alkem Laboratories LimitedAscend Laboratories, LLC | Alkem Laboratories Limited2025-10-01Human Prescription Drug Label
Aripiprazole - Preferred Pharmaceuticals Inc.Preferred Pharmaceuticals Inc.2025-01-03HUMAN PRESCRIPTION DRUG LABEL
Aripiprazole - A-S Medication SolutionsA-S Medication Solutions2024-06-05Human Prescription Drug Label
Aripiprazole - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2022-12-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-431-01Aripiprazole100 in 1 BOTTLETABLET10026
67877-431-03Aripiprazole30 in 1 BOTTLETABLET3026
67877-431-05Aripiprazole500 in 1 BOTTLETABLET50026
67877-431-32Aripiprazole1 in 1 CARTONTABLET126
67877-431-32Aripiprazole7 in 1 BLISTER PACKTABLET726
67877-431-33Aripiprazole10 in 1 BLISTER PACKTABLET1026
67877-431-38Aripiprazole10 in 1 CARTONTABLET1026

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-431ARIPIPRAZOLE TABLET [ASCEND LABORATORIES, LLC]24Current NDC, Legacy NDC, 7 package rows20240229_c7040fef-96a7-4429-9a8e-ec3ab17a8019.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-431-01EA - Each67877-431096b70ff-92f8-4a6e-896c-00827f91400812019-08-06
67877-431-03EA - Each67877-43172f7b692-5b2e-4eda-900a-93a5969faf8d12019-08-06
67877-431-05EA - Each67877-43149a1aca9-7aea-40aa-9fac-7113564970d512020-07-13

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 10 · 190 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
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
aripiprazoleARIPIPRAZOLEApotex Corp.14910dae-da81-3d73-d0a4-e98d13917c692026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
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
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
unii: 1K09F3G675
AripiprazoleARIPIPRAZOLE ORALLY DISINTEGRATINGDr. Reddy's Laboratories Inc394ea4a4-3991-4f98-b38f-56e9335d66b32026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
unii: 1K09F3G675
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.99747897-22fe-4bee-9942-6349c0c8f6b02026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 402131
unii: 82VFR53I78
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
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

Reported adverse events (FAERS/openFDA)#

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