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 46 of 46 · 911 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Heavy Metal Detox T014ALLIUM SATIVUM, AVENA SATIVA, BERBERIS VULGARIS, LAPPA MAJOR, PHYTOLACCA DECANDRA, SOLIDAGO VIRGAUREA, LYCOPODIUM CLAVATUM, NUX VOMICA, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BORON, BROMIUM, CADMIUM METALLICUM, CERIUM METALLICUM, CESIUM CHLORIDE, CHROMIUM, COBALTUM METALLICUM, CUPRUM METALLICUM, DYSPROSIUM METALLICUM, ERBIUM METALLICUM, EUROPIUM METALLICUM, FERRUM METALLICUMGuangzhou Renuma Medical Systems Co., Ltd41ce8009-71f2-418c-a38d-0cfaccfb74b42017-10-26WarningsExact identifier
unii: S7V92P67HO
Respiro-Pro T016AMMONIUM MURIATICUM, ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BRYONIA (ALBA), CALCAREA CARBONICA, LOBELIA INFLATA, NATRUM SULPHURICUM, PHOSPHORUS, SPONGIA TOSTAGuangzhou Renuma Medical Systems Co., Ltd24f5b6f1-a35a-402d-a100-1fb51a5e5a742017-10-26WarningsExact identifier
unii: S7V92P67HO
Sleep Well T012ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALISGuangzhou Renuma Medical Systems Co., Ltd2dc9026a-b847-403b-a92e-5d629e4b3c682017-10-24WarningsExact identifier
unii: S7V92P67HO
Neuro-Pro T007GABA, L-DOPA, NOREPINEPHRINE, SEROTONIN, ADRENOCORTICOTROPHIN, ANACARDIUM ORIENTALE, ARSENICUM ALBUM, BARYTA CARBONICA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, HYOSCYAMUS NIGER, LYCOPODIUM CLAVATUM, STRAMONIUMGuangzhou Renuma Medical Systems Co., Ltd7e02ab0c-9bc2-4ffe-926c-5b388a07f7b22017-10-18WarningsExact identifier
unii: S7V92P67HO
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
NeuroforceECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, ARNICA MONTANA, SYMPHYTUM OFFICINALE, AGARICUS MUSCARIUS, ARSENICUM ALBUM, GELSEMIUM SEMPERVIRENS, PLUMBUM METALLICUM, RHUS TOXBioActive Nutritional, Inc.328e1e3d-c411-413c-9a44-d0e41b7a9be42017-07-28WarningsExact identifier
unii: S7V92P67HO
Anti HiveAMMONIUM CARBONICUM, APIS MELLIFICA, ARGENTUM METALLICUM, ARSENICUM ALBUM, DULCAMARA, MEZEREUM, RHUS TOX, URTICA URENSBioActive Nutritional, Inc.e3f87bf5-91a3-4674-ae8f-1f84c8ef579b2017-03-30WarningsExact identifier
unii: S7V92P67HO
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
Food AdditivesBERBERIS VULGARIS, CHELIDONIUM MAJUS, TRIFOLIUM PRATENSE, GLYCYRRHIZA GLABRA, LAPPA MAJOR, PHYTOLACCA DECANDRA, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, XANTHOXYLUM FRAXINEUM, ARSENICUM ALBUM, BELLADONNA, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUMBioActive Nutritional, Inc.bf27d457-12e1-4ab6-b132-1b65cde0ed932016-09-28WarningsExact identifier
unii: S7V92P67HO
CerebroforceCAPSICUM ANNUUM, GINKGO BILOBA, GELSEMIUM SEMPERVIRENS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, ARSENICUM ALBUMBioActive Nutritional, Incf998ed3f-56a5-4497-be5b-9a819fe8be692016-07-13WarningsExact identifier
unii: S7V92P67HO
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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