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 32 of 46 · 911 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eye WashWATERJiangxi Zhenmei Biological Technology Co.,Ltdc68795b8-bf68-0d01-e053-2a95a90abebb2023-12-04WarningsExact identifier
unii: 059QF0KO0R
EndoparGLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, OOPHORINUM (SUIS), ORCHITINUM (BOVINE), PINEAL GLAND, THYROIDINUM, ARSENICUM ALBUM, BARYTA CARBONICA, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PULSATILLA (PRATENSIS)Energique, Inc.06375c3e-cc05-4450-9117-1d3dc72636eb2023-11-21WarningsExact identifier
unii: S7V92P67HO
MetaloginALLIUM SATIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, PHYTOLACCA DECANDRA, L-METHIONINE, THYROIDINUM (SUIS), SELENIUM DIOXIDE, LYCOPODIUM CLAVATUM, NUX VOMICA, LANTHANUM OXIDE, NIOBIUM METALLICUM, TANTALUM METALLICUM, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BORON, BROMIUM, CADMIUM METALLICUM, CERIUM METALLICUMBioActive Nutritional, Inc.2bd32205-a9d5-418a-90fd-0c3be29c04e92023-11-17WarningsExact identifier
unii: S7V92P67HO
RenotoxTRITICUM AESTIVUM, ASPARAGUS OFFICINALIS, BERBERIS VULGARIS, ECHINACEA (ANGUSTIFOLIA), KALI MURIATICUM, PETROSELINUM SATIVUM, SABAL SERRULATA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, UVA-URSI, BAROSMA (BETULINA), EUPATORIUM PURPUREUM, KIDNEY (SUIS), BRYONIA (ALBA), MERCURIUS CORROSIVUS, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BORON, BROMIUM, CADMIUM METALLICUM, CERIUM METALLICUM,BioActive Nutritional, Inc.b501f7bc-fa3a-494e-bf95-6779a3169a492023-11-17WarningsExact identifier
unii: S7V92P67HO
ARSENIC TRIOXIDEARSENIC TRIOXIDESintetica US LLCd921f52f-2f38-4300-ae40-31f00b3a500a2023-11-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA217413
ndc (package): 83090-009-10
ndc (package): 83090-009-01
ndc (package): 83090-009-05
ndc (package): 83090-010-10
ndc (package): 83090-010-05
ndc (package): 83090-010-01
ndc (product): 83090-010
ndc (product): 83090-009
ndc11 (package): 83090000905
rxcui: 829926
rxcui: 1992545
spl id: d95da146-99a2-491f-be7e-28e5fd86928f
spl set id: d921f52f-2f38-4300-ae40-31f00b3a500a
unii: S7V92P67HO
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643994f-4e13-4572-e053-2991aa0a5b782023-11-14Exact identifier
unii: QTT17582CB
Muriaticum acidumHYDROCHLORIC ACIDBoiron6907bbfe-caa5-2ce4-e053-2991aa0ade8d2023-11-14Exact identifier
unii: QTT17582CB
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643c518-13b2-658a-e053-2a91aa0ac5ed2023-11-14Exact identifier
unii: QTT17582CB
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643e30e-1f47-09f1-e053-2991aa0ac2de2023-11-14Exact identifier
unii: QTT17582CB
CV TOXCOCHLEARIA ARMORACIA, ECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, PROPOLIS, GLANDULA SUPRARENALIS BOVINE, THYMUS (SUIS), ARANEA DIADEMA, IPECACUANHA, LYCOPODIUM CLAVATUM, MURIATICUM ACIDUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, RHUS TOX, SILICEA, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, MORBILLINUM, POLIOMYELITIS NOSODE, HEPATITIS B NOSODE, COXSACKIE B1 NOSODE, CYTOMEGALOVIRUS NOSODE, COXSACKIE B4 NOSODE, EPSTEIN BARR VIRUS NOSODEBioActive Nutritional, Inc.8ef2fb5c-1b24-46a1-8d21-a78ce0a34a872023-11-07WarningsExact identifier
unii: QTT17582CB
InflammationANTHRACINUM, PYROGENIUM, ACONITUM NAP., ALOE, APIS MEL., ARNICA, ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, FERRUM PHOSPHORICUM, GAULTHERIA PROCUMBENS, HEPAR SULPH. CALC., IODIUM, LACHESIS, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, VERATRUM VIRIDE, VERBASCUM, ECHINACEANewton Laboratories, Inc.9c1edd83-5269-1363-e053-2a95a90a24dc2023-11-03WarningsExact identifier
unii: S7V92P67HO
AnxietyACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, BELLADONNA, CALCAREA CARBONICA, CARCINOSIN, CAUSTICUM, GELSEMIUM SEMPERVIRENS, LACHESIS MUTUS, LITHIUM CARBONICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NITRICUM ACIDUM, PHOSPHORUS, RHUS TOXEnergique, Inc.2fd7051b-d274-4028-8348-b175a22f045c2023-11-03WarningsExact identifier
unii: S7V92P67HO
ANTI AGE VEINACONITUM NAPELLUS - APIS MELLIFERA - ARNICA MONTANA - ARSENIC TRIOXIDE - ATROPA BELLADONNA - CALCIUM FLUORIDE - CENTELLA ASIATICA - CINCHONA OFFICINALIS BARK - CRANBERRY - HORSE CHESTNUT - IRON - LACHESIS MUTA VENOM - MERCURY - PINEAPPLE - PULSATILLA VULGARIS - SUS SCROFA ARTERY - SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE - SUS SCROFA VEIN - VISCUM ALBUM FRUIT - WITCH HAZEL -Guna spafbb27858-9e40-40c6-8c42-9fb04890097e2023-11-02WarningsExact identifier
unii: S7V92P67HO
Menstrual - PMSANGELICA SINENSIS RADIX, ARSENICUM ALB., BRYONIA, CAULOPHYLLUM, CIMICIFUGA, CINCHONA, DIOSCOREA, FOLLICULINUM, GELSEMIUM, LACHESIS, LILIUM, LYCOPODIUM, MILLEFOLIUM, NUX VOM., PULSATILLA, SABINA, SECALE, SEPIA,THLASPI, VIBURNUM OP., ZINGIBER, ECHINACEA, VALERIANANewton Laboratories, Inc.9c4a13c3-87ff-e833-e053-2995a90a8aba2023-11-02WarningsExact identifier
unii: S7V92P67HO
Food Poisoning DetoxECHINACEA PURPUREA, GLYCYRRHIZA GLABRA, HYDRASTIS CANADENSIS, PODOPHYLLUM PELTATUM, ACONITUM NAPELLUS, COLOCYNTHIS, ARSENICUM ALBUM, COLIBACILLINUM CUM NATRUM MURIATICUM, SALMONELLA TYPHI NOSODE, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS VIRIDANS, MERCURIUS CORROSIVUS, MERCURIUS SOLUBILIS, ACONITUM LYCOCTONUM, CAMPYLOBACTER JEJUNI, CLOSTRIDIUM PERFRINGENS, LISTERIA MONOCYTOGENESNutritional Specialties, Inc.9af75f01-ef40-4166-a02f-e08d49f3003e2023-11-01WarningsExact identifier
unii: S7V92P67HO
Thymus SarcodeECHINACEA PURPUREA, MYRISTICA SEBIFERA, BELLADONNA, CALCAREA SULPHURICA, THYMUS (OVINE), ARSENICUM ALBUM, SILICEA, SULPHUR IODATUM, CALCAREA FLUORICA, HEPAR SULPHURIS CALCAREUM, LACHESIS MUTUSNutritional Specialties, Inc.2dfda48f-5795-4b98-8bb2-bf65273e89202023-11-01WarningsExact identifier
unii: S7V92P67HO
Ahh SleepCOFFEA CRUDAMicro Balance Health Products08ea860f-0183-8ce8-e063-6394a90a582b2023-10-30WarningsExact identifier
unii: QTT17582CB
PollutoxSULPHURICUM ACIDUM, BERBERIS VULGARIS, ARSENICUM ALBUM, BENZINUM, CADMIUM SULPHURATUM, HYDROFLUORICUM ACIDUM, MELATONIN, NITROGENUM OXYGENATUM, NUX VOMICA, PETROLEUM, PLUMBUM METALLICUM, STANNUM METALLICUM, TOLUENE, ACETONE, CARBON DIOXIDE, CHLORINUM, MERCURIUS SOLUBILIS, URANIUM NITRICUM, OZONEDeseret Biologicals, Inc.14a1f0a6-1b22-449c-b4dd-f8feb72155542023-10-26WarningsExact identifier
unii: S7V92P67HO
Shallow Breathing FormulaARALIA QUINQUEFOLIA, ACONITUM NAPELLUS, ANTIMONIUM TARTARICUM, IPECACUANHA, BLATTA ORIENTALIS, ARSENICUM ALBUM, CUPRUM METALLICUMNutritional Specialties, Inc.a470ffff-c479-4867-aa3f-f009032b26d72023-10-12WarningsExact identifier
unii: S7V92P67HO
Lymphastat BBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, FERRUM PHOSPHORICUM, LACHESIS MUTUS, MERCURIUS CORROSIVUS, PHOSPHORUS, COLIBACILLINUM CUM NATRUM MURIATICUM, PYROGENIUMEnergique, Inc.28df9ed4-28fa-4582-945b-18b31e73740a2023-10-10WarningsExact identifier
unii: S7V92P67HO

Reported adverse events (FAERS/openFDA)#

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