FDA.reportPublic FDA data

NDC 68382-997-01 - 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
68382-997
Requested NDC
68382-997-01
Package NDCs from labels
68382-997-01, 68382-997-10
Manufacturer
Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited
Effective date
2025-02-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Arsenic trioxide - Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences LimitedZydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited2025-02-21HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-997-01Arsenic trioxide10 mL in 1 VIALINJECTION, SOLUTION108
68382-997-10Arsenic trioxide10 in 1 CARTONINJECTION, SOLUTION108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-997ARSENIC TRIOXIDE INJECTION, SOLUTION [ZYDUS PHARMACEUTICALS USA INC.]8Current NDC, Legacy NDC, 2 package rows20250226_e9d27f88-de82-4379-b143-4b94b3dd8bbe.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-997-01ML - Milliliter68382-997d50beb4f-4d42-4eeb-ba39-4e2af418071412019-01-24
68382-997-10ML - Milliliter68382-997dc9941f9-5d66-4b48-be75-0f0dfce819af12019-01-24

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
unii: S7V92P67HO
Arsenic trioxideARSENIC TRIOXIDEZydus Lifesciences Limited25e8295c-b5d9-4322-a093-d907ab1d1d352022-11-05Exact identifier
application number: ANDA206228
rxcui: 829926
unii: S7V92P67HO
Arsenic trioxideARSENIC TRIOXIDEZydus Lifesciences Limited2ad7bb19-6152-4158-a179-2388e86a981f2022-11-05Exact identifier
application number: ANDA206228
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
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.