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 2 of 10 · 183 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
ndc (package): 67046-2046-3
ndc (product): 67046-2046
rxcui: 349490
spl id: 55f3b9a3-78a6-1b71-e063-6394a90a4d8c
spl set id: 55f3a705-9412-0f88-e063-6294a90a2b53
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
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYTarget Corporation36602b7a-99c0-f6a4-e063-6294a90a87582026-06-29WarningsExact identifier
unii: 1K09F3G675
AripiprazoleARIPIPRAZOLEBryant Ranch Prepack69af5199-f872-4298-8d09-035e2127d3d42026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349545
unii: 82VFR53I78
CalaSootheCALAMINE, MENTHOL, AND ZINC OXIDEDynarex Corporation54f12005-acfe-4821-e063-6394a90ac3042026-06-24WarningsExact identifier
unii: 1K09F3G675
Calamine, Pramoxind HClCALAMINE, PRAMOXIND HCLH E B4a7a0b09-d9bc-e752-e063-6394a90a9f2c2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Calamine, Zinc OxideCALAMINE, ZINC OXIDEH E B4a79259e-64ac-d187-e063-6294a90a78db2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
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
CalamineCALAMINE AND ZINC OXIDEPharma Nobis, LLCfbcfa541-beda-06de-e053-6294a90a92982026-05-26WarningsExact identifier
unii: 1K09F3G675
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
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYCVS Pharmacydb6f518d-3a0e-43f8-8d19-7382d9b7ff1c2026-05-11WarningsExact identifier
unii: 1K09F3G675
AripiprazoleARIPIPRAZOLECoupler LLC512874e6-6d00-2623-e063-6394a90aa4bc2026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349490
unii: 82VFR53I78
CalamineFERRIC OXIDE REDRetail Business Services, LLC7291e175-a9b6-4c47-93ce-227ce11e45992026-04-30Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
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

Reported adverse events (FAERS/openFDA)#

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