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 8 of 36 · 711 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BIS II ToothPRECIPITATED CALCIUM CARBONATE, TOCOPHEROL ACETATE, ALUMINIUM CHLOROHYDROXY ALLANTOINATE, DIBASIC CALCIUM PHOSPHATE HYDRATEJewoo Medical CO.,LTD49f94296-3e74-1828-e063-6394a90a97d52026-02-03WarningsExact identifier
unii: O7TSZ97GEP
BIS II ToothPRECIPITATED CALCIUM CARBONATE, TOCOPHEROL ACETATE, ALUMINIUM CHLOROHYDROXY ALLANTOINATE, DIBASIC CALCIUM PHOSPHATE HYDRATEJewoo Medical CO.,LTD49f942e6-ceef-5505-e063-6394a90a113f2026-02-03WarningsExact identifier
unii: O7TSZ97GEP
Mold, Yeast and DustACREMONIUM STRICTUM, ADRENALINUM, ALLIUM CEPA, ALTERNARIA ALTERNATA, ARSENICUM IODATUM, ASPERGILLUS FUMIGATUS, ASPERGILLUS NIGER, AUREOBASIDIUM PULLULANS, CANDIDA ALBICANS, CLADOSPORIUM HERBARUM, COCKROACH, DERMATOPHAGOIDES FARINAE, EPICOCCUM PURPURASCENS, FUSARIUM SOLANI, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM CLAVATUM, MUCOR CIRCINELLOIDES, NATRUM SULPHURICUM, RHIZOPUS STOLONIFER, SACCHAROMYCES CEREVISIAE, SILICEANaturalCaree0f53f47-acd9-43e2-a7a2-2a500bc9dc1b2026-02-03WarningsExact identifier
unii: ETJ7Z6XBU4
BioMicroneedle PDRN CreamSILICON DIOXIDEGuangzhou Shengyanghui Industrial Trading Co., Ltd48e2edae-94ea-c42e-e063-6394a90a907b2026-01-21WarningsExact identifier
unii: ETJ7Z6XBU4
Inflammation IECHINACEA (ANGUSTIFOLIA), NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, FERRUM PHOSPHORICUM, NITRICUM ACIDUM, OLEANDER, SILICEABioActive Nutritional, Inc.3cb12181-ae7e-45c7-a1b1-e1952f36f8c32026-01-21WarningsExact identifier
unii: ETJ7Z6XBU4
HaloperidolHALOPERIDOLREMEDYREPACK INC.1e396020-899d-4f51-b71a-4982c503ca4f2026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077580
rxcui: 310672
unii: J6292F8L3D
HaloperidolHALOPERIDOLREMEDYREPACK INC.58fa9328-b1c7-407c-b215-9887db90cb942026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077580
rxcui: 310672
unii: J6292F8L3D
DENTI BUONGIORNO PLAQUE CARE LEMON MINT TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, TETRASODIUM PYROPHOSPHATEATOSAFE CO., Ltd487c5036-0eb0-ada9-e063-6394a90aa02e2026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO PLAQUE CARE LEMON MINT TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, TETRASODIUM PYROPHOSPHATEDONG IL PHARMS CO.,LTD487cd5b9-28f3-392d-e063-6394a90a9ba12026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO GUM CARE COOL MINT TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEATOSAFE CO., Ltd487cf27a-d761-6353-e063-6394a90af0292026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO FRESH BREATH HERB MINT TOOTHSILICA, SODIUM MONOFLUOROPHOSPHATEATOSAFE CO., Ltd487d52d1-8853-bc90-e063-6394a90ab91d2026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO GUM CARE COOL MINT TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEDONG IL PHARMS CO.,LTD487d689d-ebdd-43c3-e063-6294a90af0e22026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO FRESH BREATH HERB MINT TOOTHSILICA, SODIUM MONOFLUOROPHOSPHATEDONG IL PHARMS CO.,LTD487da363-1d01-8cdc-e063-6294a90ac24d2026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
Berberis QuartzBERBERIS QUARTZUriel Pharmacy Inc.5da48d70-1140-495d-b672-0e55c04196e12026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
Constipation ReliefALUMINUM OXIDE, BRYONIA ALBA ROOT, SODIUM CHLORIDE, GRAPHITE, SILICON DIOXIDEHomeocare Laboratories62374240-cd14-44e2-9405-5f8996faf0472026-01-12WarningsExact identifier
unii: LMI26O6933
unii: ETJ7Z6XBU4
Menopause ReliefBARIUM CARBONATE, ATROPA BELLADONNA, BLACK COHOSH, NITROGLYCERIN, LACHESIS MUTA VENOM, SILICON DIOXIDEHomeocare Laboratories99b182d5-4102-4b25-85d3-f4be077d753f2026-01-12WarningsExact identifier
unii: ETJ7Z6XBU4
Amber AmethystAMBER AMETHYSTUriel Pharmacy, Inc4837e805-a777-c1fa-e063-6294a90ae9c42026-01-12WarningsExact identifier
unii: ETJ7Z6XBU4
ECHINACEAECHINACEA ANGUSTIFOLIA, HAMAMMELIS VIRGINIANA, CALCAREA PHOSPHORICA, HYDRASTIS CANADANESIS, SENEGA OFFICINALIS, SILICEA, CONIUM, AURUM MURIATICUM NATRONATUM, CALCAREA CARBONICA, FUCUS VESICULOSUS, LACHESIS MUTUSMarco Pharma International LLC.7efadb70-99e4-428b-a8ef-a2797327c6fa2026-01-12WarningsExact identifier
unii: ETJ7Z6XBU4
RET Stomach 7001RET STOMACHProfessional Complementary Health Formulas086427e0-599e-4405-a996-d949023f9d902026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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