FDA.reportPublic FDA data

NDC 55154-3566-00 - Haloperidol

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
55154-3566
Requested NDC
55154-3566-00
Package NDCs from labels
55154-3566-0, 55154-3566-00
Manufacturer
Cardinal Health 107, LLC
Effective date
2026-05-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Haloperidol - Cardinal Health 107, LLCCardinal Health 107, LLC2026-05-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-3566-0Haloperidol1 in 1 BLISTER PACKTABLET16
55154-3566-0Haloperidol10 in 1 BAGTABLET106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-3566HALOPERIDOL TABLET [CARDINAL HEALTH 107, LLC]5Current NDC, Legacy NDC, 2 package rows20250312_eaabdc53-366f-4dc2-b9c7-0d70f1bbb6f9.zip

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 5 · 82 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HaloperidolHALOPERIDOLREMEDYREPACK INC.a0751f2e-05ab-4ba9-9bae-7b791bf1a6212026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310672
unii: J6292F8L3D
HaloperidolHALOPERIDOLREMEDYREPACK INC.addb5b30-d1f8-47dd-ba4c-94d0b01ae17c2026-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314035
unii: J6292F8L3D
HaloperidolHALOPERIDOLUpsher-Smith Laboratories, LLCafb3ac3e-7459-42d3-b5ca-e0d6d27ced732026-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314035
rxcui: 310672
rxcui: 197754
unii: J6292F8L3D
HaloperidolHALOPERIDOLCoupler LLC5827f1d4-ff98-03ba-e063-6394a90a46302026-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077580
rxcui: 310672
unii: J6292F8L3D
HaloperidolHALOPERIDOLREMEDYREPACK INC.051f3c99-7d16-4185-a857-c90440e1b1c52026-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197754
unii: J6292F8L3D
HaloperidolHALOPERIDOLREMEDYREPACK INC.746f3ab9-9e6e-4ce8-9384-0c7a57de80072026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077580
rxcui: 314035
unii: J6292F8L3D
HaloperidolHALOPERIDOLUnit Dose Solutions, Inc.54ee5fa9-e346-a1d0-e063-6294a90aef832026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077580
rxcui: 310672
unii: J6292F8L3D
HaloperidolHALOPERIDOLSafecor Health, LLC9be08519-b3b5-4b9d-ae4c-bb7e68f19ede2026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077580
unii: J6292F8L3D
HaloperidolHALOPERIDOLCardinal Health 107, LLCeaabdc53-366f-4dc2-b9c7-0d70f1bbb6f92026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077580
ndc (package): 55154-3566-0
ndc (product): 55154-3566
ndc11 (package): 55154356600
rxcui: 310672
spl id: d379561b-354c-442e-b689-9ffdbd96a994
spl set id: eaabdc53-366f-4dc2-b9c7-0d70f1bbb6f9
unii: J6292F8L3D
HaloperidolHALOPERIDOLCoupler LLC50b0ea2f-0a54-7b49-e063-6394a90abcc42026-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197754
unii: J6292F8L3D
HaloperidolHALOPERIDOLCoupler LLC26aa869a-25e8-0dd5-e063-6394a90a0aba2026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077580
unii: J6292F8L3D
HaloperidolHALOPERIDOLCoupler LLC509e5424-1323-c841-e063-6294a90a27142026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077580
rxcui: 314035
unii: J6292F8L3D
HaloperidolHALOPERIDOLREMEDYREPACK INC.861c7b75-572c-48c2-adf9-1ca3fc3db19b2026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J6292F8L3D
HaloperidolHALOPERIDOLPD-Rx Pharmaceuticals, Inc.533b0b4c-cbd6-4ec0-a333-8b04b5b43a1d2026-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314035
rxcui: 310672
rxcui: 197754
unii: J6292F8L3D
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
HALOPERIDOLHALOPERIDOLBryant Ranch Prepack57d77858-758c-41ce-a47c-ca42c4e888592026-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J6292F8L3D
HALOPERIDOLHALOPERIDOLBryant Ranch Prepackf6f6f2ed-33a5-4139-b2f1-ce446814e5972026-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J6292F8L3D
HALOPERIDOLHALOPERIDOLBryant Ranch Prepack7666e56f-9eef-4343-8a76-60613c4ca57f2026-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197754
unii: J6292F8L3D
HALOPERIDOLHALOPERIDOLBryant Ranch Prepackf6fb9e4c-630b-4f82-8223-f154dd6c17a22026-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314035
unii: J6292F8L3D

Reported adverse events (FAERS/openFDA)#

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