NDC 68084-249-11 - 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
68084-249
Requested NDC
68084-249-11
Package NDCs from labels
68084-249-11, 68084-249-01
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
HALOPERIDOL TABLETS, USP 8224901/0317 Rx onlyREMEDYREPACK INC.2019-10-20HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-249-01Haloperidol100 in 1 BOX, UNIT-DOSETABLET10011
68084-249-11Haloperidol1 in 1 BLISTER PACKTABLET111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-249HALOPERIDOL 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
68084-249-01EA - Each68084-24924b1899c-01b2-41ce-b19e-ee70fb98c4a612012-07-24
68084-249-11EA - Each68084-249bc325c60-cb8d-4238-95fe-c9c14b4b016c12012-07-24

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 4 of 5 · 86 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HaloperidolHALOPERIDOLPAI Holdings, LLC dba PAI Pharmab488c106-f1ee-4b7b-8516-01162fb929f72025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J6292F8L3D
HaloperidolHALOPERIDOLMylan Pharmaceuticals Inc.c559b0b0-4087-d12a-e718-c18ccb6811e62025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314035
rxcui: 314034
rxcui: 310670
rxcui: 310672
rxcui: 310671
rxcui: 197754
unii: J6292F8L3D
HaloperidolHALOPERIDOLBryant Ranch Prepacke8977803-08a2-4ad0-87d5-63d81c98a5362024-12-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314034
unii: J6292F8L3D
HaloperidolHALOPERIDOLZydus Lifesciences Limited509d0eb2-b930-4836-9669-dbebf0ac40762024-11-30Exact identifier
application number: ANDA077580
rxcui: 314035
rxcui: 314034
rxcui: 310670
rxcui: 310672
rxcui: 310671
rxcui: 197754
unii: J6292F8L3D
HaloperidolHALOPERIDOLLifestar Pharma LLC00bb61c8-db35-4c04-9ef7-47d447d2496b2024-11-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314035
rxcui: 314034
rxcui: 310670
rxcui: 310672
rxcui: 310671
rxcui: 197754
unii: J6292F8L3D
HaloperidolHALOPERIDOLAurobindo Pharma Limitedbf21633e-f37b-4017-a143-538eb005de2d2024-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314035
rxcui: 314034
rxcui: 310670
rxcui: 310672
rxcui: 310671
rxcui: 197754
unii: J6292F8L3D
HaloperidolHALOPERIDOLZydus Pharmaceuticals USA Inc.54502f78-7244-454a-9171-4e73127f14562024-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077580
ndc (product): 68382-080
ndc (product): 68382-081
rxcui: 314035
rxcui: 314034
rxcui: 310670
rxcui: 310672
rxcui: 310671
rxcui: 197754
spl id: 8d46c061-97af-4b2c-a788-bb08031d2c6f
spl set id: 54502f78-7244-454a-9171-4e73127f1456
unii: J6292F8L3D
HaloperidolHALOPERIDOLMarlex Pharmaceuticals, Inc.e7a61604-741f-2d3b-e053-2995a90a62fc2024-10-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314035
rxcui: 314034
rxcui: 310670
rxcui: 310672
rxcui: 310671
rxcui: 197754
unii: J6292F8L3D
HaloperidolHALOPERIDOLBryant Ranch Prepackd9d0e530-02cd-4631-b3c8-cf6de521fd5b2024-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310672
unii: J6292F8L3D
HaloperidolHALOPERIDOLBryant Ranch Prepackdf340d75-7387-4084-9d76-167283ee74622024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314035
unii: J6292F8L3D
HaloperidolHALOPERIDOLBryant Ranch Prepackd896823a-fb08-4777-a1f1-cef85fc8d96c2024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197754
unii: J6292F8L3D
HaloperidolHALOPERIDOLBryant Ranch Prepackf1c56d0d-87d3-40ef-9578-0d99fbae12fe2024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314034
unii: J6292F8L3D
HaloperidolHALOPERIDOLBryant Ranch Prepack88031df0-90bd-4444-9503-1b4612e3856b2024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310670
unii: J6292F8L3D
HaloperidolHALOPERIDOLBryant Ranch Prepackb9e8f5f2-6d59-4a2c-8ccf-88bb58753f602024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314035
unii: J6292F8L3D
HaloperidolHALOPERIDOLBryant Ranch Prepacka8e9d675-135c-4b5d-91d0-1ef0d295535c2024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310672
unii: J6292F8L3D
HaloperidolHALOPERIDOLBryant Ranch Prepackf20769bc-98a3-419a-ba36-2e9737050cd92024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310672
unii: J6292F8L3D
HaloperidolHALOPERIDOLBryant Ranch Prepack33dca652-c60c-44e0-9303-ea55a431fdcd2024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310671
unii: J6292F8L3D
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
HaloperidolHALOPERIDOLBryant Ranch Prepackc3b35c6c-e339-439a-b75f-dd645e08a9592024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310670
unii: J6292F8L3D
HaloperidolHALOPERIDOLBryant Ranch Prepack1171bd60-7105-4b70-a24c-f2bc8c52a8c02024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310671
unii: J6292F8L3D

Reported adverse events (FAERS/openFDA)#

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