FDA.reportPublic FDA data

NDC 68382-409-30 - 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
68382-409
Requested NDC
68382-409-30
Package NDCs from labels
68382-409-01, 68382-409-10, 68382-409-30, 68382-409-77
Manufacturer
Safecor Health, LLC
Effective date
2026-06-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Haloperidol - Safecor Health, LLCSafecor Health, LLC2026-06-11HUMAN PRESCRIPTION DRUG LABEL
Haloperidol - Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences LimitedZydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited2024-11-14HUMAN PRESCRIPTION DRUG LABEL
Haloperidol - Coupler LLCCoupler LLC2024-11-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-409-01Haloperidol100 in 1 BOTTLETABLET10015
68382-409-10Haloperidol1000 in 1 BOTTLETABLET100015
68382-409-30Haloperidol10 in 1 BLISTER PACKTABLET1015
68382-409-77Haloperidol10 in 1 CARTONTABLET1015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-409HALOPERIDOL TABLET [ZYDUS PHARMACEUTICALS USA INC.]15Current NDC, 4 package rows20241120_54502f78-7244-454a-9171-4e73127f1456.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-409-01EA - Each68382-409bf12aacf-0422-4dc8-9bb8-d7b9fb06206412023-04-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HALOPERIDOLACTIVE INGREDIENTJ6292F8L3DHALOPERIDOL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
HALOPERIDOLACTIVE MOIETYJ6292F8L3DHALOPERIDOL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LHALOPERIDOL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KHALOPERIDOL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHALOPERIDOL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPHALOPERIDOL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHALOPERIDOL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HALOPERIDOL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
POVIDONE K30INACTIVE INGREDIENTU725QWY32XHALOPERIDOL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HALOPERIDOL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHALOPERIDOL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5

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 5 of 36 · 711 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
HALOPERIDOLHALOPERIDOLBryant Ranch Prepack42549018-8f15-40b4-ac0a-8b06a2178e462026-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314034
unii: J6292F8L3D
HALOPERIDOLHALOPERIDOLBryant Ranch Prepack7212f03f-caa0-43bc-aac5-9d8b3c3048972026-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310672
unii: J6292F8L3D
HaloperidolHALOPERIDOLNCS HealthCare of KY, LLC dba Vangard Labs8743da03-67f1-4cb0-8159-45141cb5466e2026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314035
rxcui: 310672
unii: J6292F8L3D
HaloperidolHALOPERIDOLREMEDYREPACK INC.a3afd19a-c340-4fad-8ddd-d712425153452026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314035
unii: J6292F8L3D
HaloperidolHALOPERIDOLREMEDYREPACK INC.22598f07-501b-471a-b512-449d95e2301c2026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310672
unii: J6292F8L3D
DentastatALLIUM SATIVUM, BERBERIS VULGARIS, FUCUS VESICULOSUS, PHYTOLACCA DECANDRA, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, IODIUM, MERCURIUS SOLUBILIS, NICCOLUM METALLICUM, PALLADIUM METALLICUM, PHOSPHORUS, SILICEA, TITANIUM METALLICUM, ZINCUM METALLICUM, PLATINUM METALLICUM, PYROGENIUMEnergique, Inc.7f6d360b-9fee-4374-a47c-847806d54fa02026-04-13WarningsExact identifier
unii: ETJ7Z6XBU4
Animal Hair and DanderADRENALINUM, ALLIUM CEPA, ARSENICUM IODATUM, CAT (DANDER), DOG (DANDER), EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, SABADILLA, SHEEP WOOL, SILICEANaturalCaref0067255-9310-43a0-b415-c03a0f554bcc2026-04-10WarningsExact identifier
unii: ETJ7Z6XBU4
Quantum ResonanceALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUMDeseret Biologicals, Inc.f94a10bd-1c40-42c7-b458-b580706145492026-04-10WarningsExact identifier
unii: ETJ7Z6XBU4
Quantum ResonanceALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUMDeseret Biologicals, Inc.1467111a-bef6-473d-b7f2-3309a9bb72ce2026-04-10WarningsExact identifier
unii: ETJ7Z6XBU4
HaloperidolHALOPERIDOLAiPing Pharmaceutical, Incbacc68ed-717b-477a-afa4-c45c182c617b2026-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314035
rxcui: 314034
rxcui: 310670
rxcui: 310672
rxcui: 310671
rxcui: 197754
unii: J6292F8L3D
H-Focus FormulaAGNUS CASTUS, AVENA SATIVA, BARYTA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, SILICEA, ZINCUM METALLICUMHealing Natural Oils LLC4ee42911-3064-7f55-e063-6294a90abcc72026-04-07WarningsExact identifier
unii: ETJ7Z6XBU4
H-Mood FormulaAGRIMONIA EUPATORIA, FLOS, ANACARDIUM ORIENTALE, AURUM METALLICUM, AVENA SATIVA, BORAGO OFFICINALIS, CAPSICUM ANNUUM, CARPINUS BETULUS, FLOS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, HYPERICUM PERFORATUM, KALI BROMATUM, LARIX DECIDUA, FLOS, NATRUM CARBONICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PULSATILLA, SILICEA, SINAPSIS ARVENSIS, FLOS, TABACUMHealing Natural Oils LLC4ee5c82e-9edf-c36e-e063-6394a90a237f2026-04-07WarningsExact identifier
unii: ETJ7Z6XBU4
Sinus DefenseLAC VACCINUM, SILICEA, ASPERGILLUS NIGER, BABESIA MICROTI, BORRELIA BURGDORFERI, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, CHLAMYDIA TRACHOMATIS, COLIBACILLINUM CUM NATRUM MURIATICUM, CYTOMEGALOVIRUS NOSODE, EHRLICHIA NOSODE, HERPES SIMPLEX I AND II NOSODE, HUMAN PAPILLOMA NOSODE, KLEBSIELLA PNEUMONIAE, MUCOR RACEMOSUS, MYCOBACTERIUM PARATUBERCULOSIS, PNEUMOCCOCCINUM, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS VIRIDANS, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODEMicro Balance Health Products LLC9c2f51c5-aa41-414e-a966-32e02e9e79a22026-04-02WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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