FDA.reportPublic FDA data

NDC 65841-784-30 - buspirone hydrochloride

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
65841-784
Requested NDC
65841-784-30
Package NDCs from labels
65841-784-14, 65841-784-10, 65841-784-30, 65841-784-77, 65841-784-05
Manufacturer
Zydus Lifesciences Limited
Effective date
2025-12-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
buspirone hydrochloride - Zydus Lifesciences LimitedZydus Lifesciences Limited2025-12-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65841-784-05buspirone hydrochloride500 in 1 BOTTLETABLET5009
65841-784-10buspirone hydrochloride1000 in 1 BOTTLETABLET10009
65841-784-14buspirone hydrochloride60 in 1 BOTTLETABLET609
65841-784-30buspirone hydrochloride1 in 1 BLISTER PACKTABLET19
65841-784-77buspirone hydrochloride100 in 1 CARTONTABLET1009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-784BUSPIRONE HYDROCHLORIDE TABLET [ZYDUS LIFESCIENCES LIMITED]8Current NDC, Legacy NDC, 5 package rows20241128_1109dd63-6492-49b1-a383-3ab3a80cd6c7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HYDROCHLORIDE TABLET [CADILA HEALTHCARE LIMITED]1
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE TABLET [CADILA HEALTHCARE LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HYDROCHLORIDE TABLET [CADILA HEALTHCARE LIMITED]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HYDROCHLORIDE TABLET [CADILA HEALTHCARE LIMITED]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBUSPIRONE HYDROCHLORIDE TABLET [CADILA HEALTHCARE LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HYDROCHLORIDE TABLET [CADILA HEALTHCARE LIMITED]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HYDROCHLORIDE TABLET [CADILA HEALTHCARE LIMITED]1

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 12 of 39 · 764 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VACC HCANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BRYONIA (ALBA), ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYOSCYAMUS NIGER, INFLUENZINUM, LEDUM PALUSTRE, MERCURIUS SOLUBILIS, MEZEREUM, NICOTINAMIDUM, HUMAN CORONAVIRUS (RNA), SENEGA OFFICINALIS, SILICEA, SPIGELIA ANTHELMIA, SULPHUR, THUJA OCCIDENTALIS, ZINCUM METALLICUMDeseret Biologicals, Inc.16d782b2-1bef-45e5-8a1d-721b1ffe56312026-01-05WarningsExact identifier
unii: ETJ7Z6XBU4
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEProficient Rx LP1521109d-8386-472f-9483-f1fe9f7ed1522026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 866083
rxcui: 866090
rxcui: 866094
rxcui: 866018
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDENorthwind Health Company, LLCf318ba7b-121f-2e4f-e053-2a95a90a60c52026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 866111
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDENorthwind Health Company, LLCd9de7cf1-c38d-8b3c-e053-2995a90aa26b2026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 866083
unii: 207LT9J9OC
blood sugarCALC PHOS, CARPINUS BETULUS, FLOS, FERRUM PHOS, KALI PHOS, NAT MUR, NAT SULPH, OLEA EUROPAEA, FLOS, SILICEA, SINAPIS ARVENSIS, FLOSSiddha Flower Essences, LLC90ecd62b-c4bc-4bc4-a409-219929a49edb2025-12-31WarningsExact identifier
unii: ETJ7Z6XBU4
throat and voiceCERATOSTIGMA WILLMOTTIANUM, FLOS, FERRUM PHOS, HOTTONIA PALUSTRIS, FLOS, KALI MUR, KALI PHOS, MAG PHOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT SULPH, SILICEASiddha Flower Essences LLC375ef37c-d5de-4762-a569-7304d98825202025-12-31WarningsExact identifier
unii: ETJ7Z6XBU4
healthy hairCERTOSTIGMA WILLMOTTIANUM, FLOS, KALI SULPH, LARIX DECIDUA, FLOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT PHOS, SILICEASiddha Flower Essences LLC2b49fb7a-8d8b-4cef-8f8d-515c54451bfd2025-12-31WarningsExact identifier
unii: ETJ7Z6XBU4
sightAESCULUS HIPPOCASTANUM, BUD, BROMUS RAMOSUS, FLOS, CALC FLUORICA, CALC PHOS, CALC SULPH, CLEMATIS VITALBA, FLOS, FERRUM PHOS, MAG PHOS, NAT MUR, SILICEASiddha Flower Essences LLCe6a5a50f-873e-4aa0-ad66-ccfa70c75cde2025-12-31WarningsExact identifier
unii: ETJ7Z6XBU4
mind and memoryAESCULUS HIPPOCASTANUM FLOS, CALC PHOS, CALC SULPH, CLEMATIS VITALBA FLOS, KALI PHOS, MAG PHOS, NAT MUR, SCLERANTHUS ANNUUS FLOW, SILICEASiddha Flower Essences LLC0d35b9a2-2123-4c14-b0b8-f45f3820ee032025-12-31WarningsExact identifier
unii: ETJ7Z6XBU4
youthful skinAESCULUS HIPPOCASTANUM, BUD, AGRIMONIA EUPATORIA, FLOS, CALC FLUORICA, CALC SULPH, FERRUM PHOS, KALI SULPH, MALUS PUMILA, FLOS, NAT MUR, SILICEASiddha Flower Essences LLC6f72f1b9-d627-4110-9546-13320e62c4652025-12-31WarningsExact identifier
unii: ETJ7Z6XBU4
male balanceCENTARIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, KALI PHOS, LARIX DECIDUA, FLOS, LYCOPODIUM, NAT MUR, NAT PHOS, SILICEASiddha Flower Essences LLC61b7cfe0-1465-482b-97dd-8fbb8d420a932025-12-31WarningsExact identifier
unii: ETJ7Z6XBU4
muscles and jointsCALC FLUOR, CALC PHOS, CARPINUS BETULUS, FLOS, ILEX AQUIFOLIUM, FLOS, KALI SULPH, MAG PHOS, NAT PHOS, QUERCUS ROBUR, FLOS, SILICEASiddha Flower Essences LLC421e61e4-f9df-48e1-bff3-80148a5de5cf2025-12-31WarningsExact identifier
unii: ETJ7Z6XBU4
ONETOOTHCLINIC TOOTHSILICON DIOXIDE, TOCOPHEROL ACETATE, SODIUM PYROPHOSPHATECONE MEDICAL Co., Ltd.9a567c9e-b8ce-7bf1-e053-2995a90aff2b2025-12-30WarningsExact identifier
unii: ETJ7Z6XBU4
ONETOOTH CLINIC TOOTHSILICON DIOXIDE, TOCOPHEROL ACETATE, TETRASODIUM PYROPHOSPHATECONE MEDICAL Co., Ltd.bd50abcd-8a85-2923-e053-2995a90a109b2025-12-30WarningsExact identifier
unii: ETJ7Z6XBU4
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDENorthwind Health Company, LLCff02c7cb-f96a-4a3b-99a2-812cd78b345c2025-12-26Warnings, Adverse reactionsExact identifier
rxcui: 866018
unii: 207LT9J9OC
buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEZydus Lifesciences Limited1109dd63-6492-49b1-a383-3ab3a80cd6c72025-12-24Exact identifier
application number: ANDA078888
ndc (package): 65841-781-30
ndc (package): 65841-781-77
ndc (package): 65841-783-30
ndc (package): 65841-784-30
ndc (package): 65841-842-30
ndc (package): 65841-781-05
ndc (package): 65841-784-14
ndc (package): 65841-782-30
ndc (package): 65841-784-10
ndc (package): 65841-783-77
ndc (package): 65841-782-77
ndc (package): 65841-784-05
ndc (package): 65841-842-05
ndc (package): 65841-783-05
ndc (package): 65841-784-77
ndc (package): 65841-842-01
ndc (package): 65841-781-10
ndc (package): 65841-783-14
ndc (package): 65841-781-01
ndc (package): 65841-783-10
ndc (package): 65841-783-28
ndc (package): 65841-842-10
ndc (package): 65841-782-05
ndc (package): 65841-782-10
ndc (package): 65841-782-01
ndc (package): 65841-783-01
ndc (product): 65841-783
ndc (product): 65841-842
ndc (product): 65841-784
ndc (product): 65841-781
ndc (product): 65841-782
ndc11 (package): 65841078430
rxcui: 866083
rxcui: 866111
rxcui: 866090
rxcui: 866094
rxcui: 866018
spl id: 0ea86a43-52f7-4fad-acda-a4625f4280a2
spl set id: 1109dd63-6492-49b1-a383-3ab3a80cd6c7
unii: 207LT9J9OC
StellaLife VEGA Oral CareSPRAYStellaLife, Inc.b8ba495e-2cfe-092c-e053-2995a90a3fd32025-12-24WarningsExact identifier
unii: ETJ7Z6XBU4
StellaLife VEGA Oral Care Recovery KitKITHomeocare Laboratories, Inc.b701234a-0bd2-16d3-e053-2995a90a5b132025-12-24WarningsExact identifier
unii: ETJ7Z6XBU4
StellaLife VEGA Oral Care Peppermint Pain and Swelling ReliefARNICA, CALENDULA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, HEPAR SULPH CALC, HYPERICUM, LGNATIA, LEDUM PALUSTRE, RUTA, SILICEA, STAPHYSAGRIAStellaLife, Inc.10d42c12-713a-f461-e063-6294a90a223b2025-12-22WarningsExact identifier
unii: ETJ7Z6XBU4
StellaLife VEGA Oral Care Pain and Swelling ReliefARNICA, CALENDULA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, HEPAR SULPH CALC, HYPERICUM, LGNATIA, RUTA, STAPHYSAGRIAStellaLife, Inc.10f8dee1-d5d3-0602-e063-6294a90a6dbf2025-12-22WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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