FDA.reportPublic FDA data

NDC 67877-433-33 - 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
67877-433
Requested NDC
67877-433-33
Package NDCs from labels
67877-433-03, 67877-433-01, 67877-433-05, 67877-433-33, 67877-433-38, 67877-433-32
Manufacturer
REMEDYREPACK INC.
Effective date
2026-07-30
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.2026-07-30HUMAN PRESCRIPTION DRUG LABEL
Aripiprazole - Coupler LLCCoupler LLC2026-07-06HUMAN PRESCRIPTION DRUG LABEL
Aripiprazole - Bryant Ranch PrepackBryant Ranch Prepack2026-01-28HUMAN PRESCRIPTION DRUG LABEL
Aripiprazole - Ascend Laboratories, LLC | Alkem Laboratories LimitedAscend Laboratories, LLC | Alkem Laboratories Limited2025-10-01Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-433-01Aripiprazole100 in 1 BOTTLETABLET10026
67877-433-03Aripiprazole30 in 1 BOTTLETABLET3026
67877-433-05Aripiprazole500 in 1 BOTTLETABLET50026
67877-433-32Aripiprazole1 in 1 CARTONTABLET126
67877-433-32Aripiprazole7 in 1 BLISTER PACKTABLET726
67877-433-33Aripiprazole10 in 1 BLISTER PACKTABLET1026
67877-433-38Aripiprazole10 in 1 CARTONTABLET1026

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-433ARIPIPRAZOLE 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
67877-433-01EA - Each67877-433bd47d6d0-84af-4087-aca8-c184b2e501e312019-08-06
67877-433-03EA - Each67877-43362f42f38-aa2a-47ea-ba33-9f69c11ba69312019-08-06
67877-433-05EA - Each67877-4335d426b23-cd0e-49cd-a1fe-b1adda85487712020-07-13

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 3 of 10 · 183 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalamineCALAMINE 8%, ZINC OXIDE 8%Farmacias De Similares TX LLC4ecd0add-11c9-cf3b-e063-6394a90adff62026-04-06WarningsExact identifier
unii: 1K09F3G675
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
rxcui: 402131
unii: 82VFR53I78
PowderTITANIUM DIOXIDEOxygen Development LLC4d3a0a92-b0de-a1ea-e063-6294a90a85082026-03-17WarningsExact identifier
unii: 1K09F3G675
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
CalamineCALAMINE, PRAMOXINE HCLAmazon.com Services LLCaceb0b10-8c90-4a06-8c47-cd1a2b4676a32026-03-03Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDOld East Main Co.c38c77fd-abbf-4c87-a9c0-a0e21ed3f97d2026-03-02Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDChain Drug Marketing Association86ff4875-9007-4b7b-8f46-16cbd475d4bb2026-02-27Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXINE HCLChain Drug Marketing Association6c848b98-f01c-40f2-a9aa-2af76cb370c82026-02-27Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Levico PrunusLEVICO PRUNUSUriel Pharmacy Inc.63db9374-8ee2-48cf-8799-454c958698082026-02-27WarningsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDFamily Dollar Stores, Inc1a03331e-3676-451c-be22-9a547e8ae6e22026-02-24Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDPerrigo Direct, Inc256bd1d4-fd50-408f-9aee-84f218bb49712026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXIND HCLPerrigo Direct, Inc54a20ec9-ab86-4410-af94-e04393e9d4b32026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXINE HCLMeijer, Inc.6b369ef2-fd54-4931-a9eb-0fb42834c2ef2026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDTarget Corporationd4ee05c8-ae62-45df-8783-1ed57fa030ec2026-02-18Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDTopco Associates LLC2b32e720-ac71-4d60-bc06-e28a00f8a4502026-02-13Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXINE HCLTopco Associates LLC15d1ae3f-509c-4e6b-8f0c-cf92656803582026-02-13Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

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