NDC 68084-250-11 - 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
68084-250
Requested NDC
68084-250-11
Package NDCs from labels
68084-250-11, 68084-250-21
Manufacturer
American Health Packaging
Effective date
2025-06-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Haloperidol - American Health PackagingAmerican Health Packaging2025-06-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-250-11Haloperidol1 in 1 BLISTER PACKTABLET111
68084-250-21Haloperidol30 in 1 BOX, UNIT-DOSETABLET3011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-250HALOPERIDOL TABLET [AMERICAN HEALTH PACKAGING]10Current NDC, Legacy NDC, 2 package rows20240723_0ac0cc44-3924-447d-9051-f84c44312380.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-250-11EA - Each68084-2506bcabb55-6169-4073-87c3-b2e1d3caa6d012014-02-04
68084-250-21EA - Each68084-250b03276a2-9cd3-4dfb-a9ec-bb26dc5e847c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HALOPERIDOLACTIVE INGREDIENTJ6292F8L3DHALOPERIDOL TABLET [AMERICAN HEALTH PACKAGING]2
HALOPERIDOLACTIVE MOIETYJ6292F8L3DHALOPERIDOL TABLET [AMERICAN HEALTH PACKAGING]2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPHALOPERIDOL TABLET [AMERICAN HEALTH PACKAGING]2
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LHALOPERIDOL TABLET [AMERICAN HEALTH PACKAGING]2
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KHALOPERIDOL TABLET [AMERICAN HEALTH PACKAGING]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHALOPERIDOL TABLET [AMERICAN HEALTH PACKAGING]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHALOPERIDOL TABLET [AMERICAN HEALTH PACKAGING]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HALOPERIDOL TABLET [AMERICAN HEALTH PACKAGING]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XHALOPERIDOL TABLET [AMERICAN HEALTH PACKAGING]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HALOPERIDOL TABLET [AMERICAN HEALTH PACKAGING]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHALOPERIDOL TABLET [AMERICAN HEALTH PACKAGING]2

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 · 85 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: 314034
rxcui: 310670
rxcui: 310672
rxcui: 310671
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
rxcui: 314034
rxcui: 310670
rxcui: 310671
unii: J6292F8L3D
HaloperidolHALOPERIDOLCardinal Health 107, LLCeaabdc53-366f-4dc2-b9c7-0d70f1bbb6f92026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077580
rxcui: 310672
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
rxcui: 310671
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
rxcui: 310671
unii: J6292F8L3D
HaloperidolHALOPERIDOLPD-Rx Pharmaceuticals, Inc.533b0b4c-cbd6-4ec0-a333-8b04b5b43a1d2026-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314035
rxcui: 314034
rxcui: 310670
rxcui: 310672
rxcui: 310671
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
rxcui: 310671
unii: J6292F8L3D
HALOPERIDOLHALOPERIDOLBryant Ranch Prepackf6f6f2ed-33a5-4139-b2f1-ce446814e5972026-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310670
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.