FDA.reportPublic FDA data

NDC 83090-009-05 - ARSENIC TRIOXIDE

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
83090-009
Requested NDC
83090-009-05
Package NDCs from labels
83090-009-05, 83090-009-01, 83090-009-10
Manufacturer
Sintetica US LLC | MSN Laboratories Private Limited
Effective date
2023-11-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ARSENIC TRIOXIDE - Sintetica US LLC | MSN Laboratories Private LimitedSintetica US LLC | MSN Laboratories Private Limited2023-11-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83090-009-01ARSENIC TRIOXIDE1 in 1 CARTONINJECTION, SOLUTION11
83090-009-05ARSENIC TRIOXIDE10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION101
83090-009-10ARSENIC TRIOXIDE10 in 1 CARTONINJECTION, SOLUTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83090-009ARSENIC TRIOXIDE INJECTION, SOLUTION [SINTETICA US LLC]1Current NDC, 3 package rows20240119_d921f52f-2f38-4300-ae40-31f00b3a500a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83090-009-01ML - Milliliter83090-00902b1acac-b37f-4523-ae89-dfc322bc5ff512024-04-05
83090-009-10ML - Milliliter83090-0094685f803-083b-467d-8607-44a7fdf6accc12024-04-05

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 38 of 46 · 911 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cough HPARSENICUM ALBUM, BRYONIA ALBA, CUPRUM ACENTICUM, DROSERA ROTUNDIFOLIA, IPECACUANHA, KALI CARBONICUM, PHOSPHORUS, PULSATILLA, SPONGIA TOSTANatural Creations, Inc62ae8d8f-67c8-4347-b910-a173d8283b182022-11-23WarningsExact identifier
unii: S7V92P67HO
Adrenal SupportHUMULUS LUPULUS, ADRENALINUM, CORTISONE ACETICUM, SELENIUM METALLICUM, THYROIDINUM (SUIS), ARSENICUM ALBUM, CALCAREA CARBONICA, CONVALLARIA MAJALIS, CROTALUS HORRIDUS, FERRUM METALLICUM, NUX VOMICA, PHOSPHORUS, SEPIA, PHOSPHORICUM ACIDUMDeseret Biologicals, Inc.e7e01040-df38-4628-96d0-4df3420546a42022-11-09WarningsExact identifier
unii: S7V92P67HO
PYROGENIUM PLEXARSENICUM ALBUM, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, KALI IODATUM, PYROGENIUMSeroyal USA270f98ff-2f0e-6926-e054-00144ff8d46c2022-11-09WarningsExact identifier
unii: S7V92P67HO
Arsenic TrioxideARSENIC TRIOXIDESagent Pharmaceuticals7fe0fe9f-e87b-44ab-b92c-9b3d239420632022-11-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 829926
rxcui: 1992545
unii: S7V92P67HO
Arsenic trioxideARSENIC TRIOXIDEZydus Lifesciences Limited25e8295c-b5d9-4322-a093-d907ab1d1d352022-11-05Exact identifier
rxcui: 829926
unii: S7V92P67HO
Arsenic trioxideARSENIC TRIOXIDEZydus Lifesciences Limited2ad7bb19-6152-4158-a179-2388e86a981f2022-11-05Exact identifier
rxcui: 1992545
unii: S7V92P67HO
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SCIATIC AIDEARSENIC TRIOXIDE, CHAMOMILE, CITRULLUS COLOCYNTHIS FRUIT PULP, SULFURSchwabe North America, Inc6b239879-dd7b-41bf-8d14-b6d6030d6e932022-07-26WarningsExact identifier
unii: S7V92P67HO
SCIATICAIDEARSENIC TRIOXIDE, CHAMOMILE, CITRULLUS COLOCYNTHIS FRUIT PULP, SULFURSchwabe Mexico S.A. de C.V.e2c234a3-bbaf-4d84-b3ef-ad9c4f7c473f2022-07-26WarningsExact identifier
unii: S7V92P67HO
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Adrenal SupportARALIA QUINQUEFOLIA, HUMULUS LUPULUS, ADRENALINUM, CORTISONE ACETICUM, SELENIUM METALLICUM, THYROIDINUM (SUIS), ARSENICUM ALBUM, CALCAREA CARBONICA, CONVALLARIA MAJALIS, CROTALUS HORRIDUS, FERRUM METALLICUM, NUX VOMICA, PHOSPHORUS, SEPIA, PHOSPHORICUM ACIDUMDeseret Biologicals, Inc.37a7f63c-4241-492b-af7c-7e5bbe0a08892022-06-21WarningsExact identifier
unii: S7V92P67HO
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Stomach SaverABIES NIG, ANTIMON CRUD, ARG NIT, ARSENICUM ALB, CARBO VEG, CINCHONA, LYCOPODIUM, NAT PHOS, NUX MOSCH, NUX VOM, PODOPH PELT, ROBINIASilver Star Brandse0048c51-74e3-a7ff-e053-2995a90a1d412022-05-27WarningsExact identifier
unii: S7V92P67HO
Arsenic TrioxideARSENIC TRIOXIDESandoz Inca9008658-c2dd-49f4-b1c4-26e232c819572022-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1992545
unii: S7V92P67HO
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: S7V92P67HO
UNDA 15ALLIUM CEPA, AURUM METALLICUM, EUCALYPTUS GLOBULUS, INULA HELENIUM, TRIGONELLA FOENUM-GRAECUMSeroyal USA16ee1833-db7c-46fe-e054-00144ff88e882022-04-28WarningsExact identifier
unii: S7V92P67HO
Ear CareECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUMNewton Laboratories, Inc.da807eb3-34a3-61b9-e053-2995a90a0e212022-03-18WarningsExact identifier
unii: S7V92P67HO

Reported adverse events (FAERS/openFDA)#

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