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 5 of 39 · 764 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM Silicea Icing SugarSILICEA ICING SUGARTotal Operations Management LLC DBA:Bestmade Natural Products Micro535ba100-627f-36b4-e063-6394a90a33732026-06-03WarningsExact identifier
unii: ETJ7Z6XBU4
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEABM Private Limited5331dc40-2ac8-5fce-e063-6394a90a58752026-06-01WarningsExact identifier
unii: ETJ7Z6XBU4
DentaforceANTIMONIUM CRUDUM, BELLADONNA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, SEPIA, SILICEA, HYDROFLUORICUM ACIDUMBioActive Nutritional, Inc.82321547-e04a-42ff-aa39-6a192638e5a22026-05-18WarningsExact identifier
unii: ETJ7Z6XBU4
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack66df7f74-5dea-46d6-9ef8-9bab37baf4072026-05-14Warnings, Adverse reactionsExact identifier
rxcui: 866083
unii: 207LT9J9OC
C07 STRONG LIGAMENTS AND JOINTSARNICA MONTANA, ASCORBICUM ACIDUM, BOS TAURUS LYMPH VESSEL, INTERVERTEBRAL FIBROCARTILAGE, BOS TAURUS MESENCHYME, CALCAREA PHOSPHORICA, CARTILAGO SUIS, FORMICUM ACIDUM, LAPIS ALBUS, PINUS MONTANA LEAFY TWIG, RHAMNUS CALIFORNICA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SUS SCROFA JOINT ENVELOPE, SUS SCROFA LIGAMENT, SUS SCROFA MENISCUS, SUS SCROFA PARATHYROID GLAND, SUS SCROFA VEIN, SYMPHYTUM OFFICINALEApex Energetics Inc.bccf8c83-a6cd-e58c-e053-2a95a90a43d72026-05-13WarningsExact identifier
unii: ETJ7Z6XBU4
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack225575f1-9635-4922-8286-d479d6480bf02026-05-13Warnings, Adverse reactionsExact identifier
rxcui: 866018
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepackeee7fa99-a9a1-4299-8a3d-6c2dd90948c92026-05-13Warnings, Adverse reactionsExact identifier
rxcui: 866090
unii: 207LT9J9OC
Acne ReliefBELLADONNA, SILICEA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, KALI BROMATUM, LEDUM PALUSTRE, NATRUM MURIATICUM, SELENIUM, SULPHURNaturalCare487b1373-b78c-4510-964a-6ab0fe781ff42026-05-08WarningsExact identifier
unii: ETJ7Z6XBU4
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, SILICEA, ZINCUM METALLICUM, PLATINUM METALLICUMEnergique, Inc.12786efd-df42-4321-bfdf-88f542d387bb2026-05-06WarningsExact identifier
unii: ETJ7Z6XBU4
Age Defiance Pro7-OXO-DEHYDROEPIANDROSTERONE-3B-ACETATE, CALCAREA CARBONICA, CONIUM MACULATUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYDROFLUORICUM ACIDUM, HYPOPHYSIS SUIS, LYCOPODIUM CLAVATUM, SELENIUM METALLICUM, SEPIA, SILICEA, HUMAN GROWTH HORMONEEnergique, Inc.d528bdbe-fb75-4b13-9cbc-efa2177d74d82026-05-06WarningsExact identifier
unii: ETJ7Z6XBU4
Pollen HayfeverADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM IODATUM, MUGWORT POLLEN (ARTEMISIA VULGARIS), BELLIS PERENNIS, BRASSICA SPP, CHENOPODIUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, ALFALFA POLLEN (MEDICAGO SATIVA), PHLEUM PRATENSE, YELLOW DOCK POLLEN (RUMEX CRISPUS), SABADILLA, SILICEA, GOLDENROD POLLEN (SOLIDAGO CANADENSIS), DANDELION POLLEN (TARAXACUM OFFICINALE), RED CLOVER POLLEN (TRIFOLIUM PRATENSE), XANTHIUM STRUMARIUMNaturalCare00665933-176e-4f16-b6ee-b55217b8abb32026-05-05WarningsExact identifier
unii: ETJ7Z6XBU4
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAsclemed USA, Inc.97f2d082-0931-4e4f-a5be-7792e399e42b2026-05-04Warnings, Adverse reactionsExact identifier
rxcui: 866083
rxcui: 866090
rxcui: 866094
rxcui: 866018
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDECoupler LLC510120d3-c922-a071-e063-6294a90af6a72026-05-04Warnings, Adverse reactionsExact identifier
rxcui: 866094
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDENuCare Pharmaceuticals, Inc.50b18368-d37c-374b-e063-6394a90a81142026-04-30Warnings, Adverse reactionsExact identifier
rxcui: 866083
unii: 207LT9J9OC
Hydrate ICOFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEABioActive Nutritional, Inc.c0c8d350-0257-4484-acd8-f852350173db2026-04-30WarningsExact identifier
unii: ETJ7Z6XBU4
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDECardinal Health 107, LLC1315494d-7a51-4395-bc7c-afb4bc5482c92026-04-24Warnings, Adverse reactionsExact identifier
application number: ANDA078888
rxcui: 866018
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEREMEDYREPACK INC.5b4da3f8-a5ce-4699-92e1-37fb95e0af2d2026-04-23Warnings, Adverse reactionsExact identifier
rxcui: 866094
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDECardinal Health 107, LLC5424f933-93e1-4480-acdf-bd8667ae50e92026-04-15Warnings, Adverse reactionsExact identifier
rxcui: 866083
rxcui: 866094
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC093b701d-4a43-4871-b726-c5820fa3ab952026-04-14Warnings, Adverse reactionsExact identifier
rxcui: 866083
unii: 207LT9J9OC
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

Reported adverse events (FAERS/openFDA)#

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