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 40 of 46 · 911 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arsenicum AlbumARSENICUM ALBUMOHM PHARMA INC.3c9024e9-388d-442a-93b4-8126225665622021-12-29WarningsExact identifier
unii: S7V92P67HO
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GUNA STOMACH PLUSANTIMONIUM CRUDUM - ARGENTUM NITRICUM - ARSENICUM ALBUM - IPECACUANHA - NUX VOMICA - ORIGANUM MAJORANA - CUPRUM METALLICUM - TARAXACUM OFFICINALE - NATRUM PHOSPHORICUM -Guna spaba495fce-b7ad-af83-e053-2a95a90a388a2021-12-15WarningsExact identifier
unii: S7V92P67HO
GUNA HAY FEVER RELIEFSTRYCHNOS NUX VOMICA SEED - HISTAMINE DIHYDROCHLORIDE - MANGANESE - SCHOENOCAULON OFFICINALE SEED - APIS MELLIFERA - ARSENIC TRIOXIDE - SILVER NITRATE - ONION - EUPHRASIA STRICTA - GALPHIMIA GLAUCA FLOWERING TOP - SULFUR -Guna spab8db4fc6-f235-6f2b-e053-2a95a90a186f2021-12-15WarningsExact identifier
unii: S7V92P67HO
ARSENICUM ALBUMARSENICUM ALBUMRxhomeo Private Limited d.b.a. Rxhomeo, Ince4f05f24-6214-42f4-a76c-7d6c31ce06502021-08-23WarningsExact identifier
unii: S7V92P67HO
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Arsenic TrioxideARSENIC TRIOXIDEAmneal Pharmaceuticals LLC5845022e-8c01-451b-ae49-a28e58c5f8452021-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 829926
unii: S7V92P67HO
FungisodeARSENICUM ALBUM, BERBERIS VULGARIS, CALCAREA CARBONICA, CANDIDA ALBICANS, CARBO VEGETABILIS, CHELIDONIUM MAJUS, ECHINACEA PURPUREA, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MURIATICUM ACIDUM, NITRICUM ACIDUM, OXALICUM ACIDUM, SEPIA OFFICINALIS, SULPHURSeroyal USA55c5dfc4-3757-6ac2-e054-00144ff88e882021-07-22WarningsExact identifier
unii: S7V92P67HO
unii: QTT17582CB
Sleep AidADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH)Pro Weight Loss Inc.d0af311a-e975-4236-8c0e-0418efa7e45f2021-07-16WarningsExact identifier
unii: S7V92P67HO
Unda 3EQUISETUM ARVENSE STEM, CHAMOMILLA, CONDURANGO BARK, VIOLA TRICOLOR, BOLDO LEAF, ALUMINIUM METALLICUM, STANNUM METALLICUMSeroyal USA1583cf73-c22c-0fa8-e054-00144ff8d46c2021-07-15WarningsExact identifier
unii: S7V92P67HO
HemorrhoidsELAPS CORALLINUS, AESCULUS HIPP., ALOE, ARSENICUM ALB., BRYONIA, CALC. FLUOR., CAPSICUM, COLLINSONIA, CROTALUS HORRIDUS, HAMAMELIS, HYDROFLUORICUM ACIDUM, HYPERICUM, LACHESIS, LYCOPODIUM, MILLEFOLIUM, NAJA, NUX VOM., PAEONIA, PLANTAGO, QUERCUS GLANDIUM SPIRITUS, RATANHIA, VIPERA BERUS, ECHINACEA, SOLIDAGO, URTICA UR.Newton Laboratories, Inc.c6f30a27-ae7f-2574-e053-2995a90a91022021-07-12WarningsExact identifier
unii: S7V92P67HO
Post - VaccinationINFLUENZINUM, MORBILLINUM, PERTUSSINUM, ACONITUM NAP., ALUMINA, ANTIMON. TART., ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CINCHONA, CROTALUS HORRIDUS, GELSEMIUM, KALI BIC., LACHESIS, LEDUM, MERC. VIV., MEZEREUM, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SILICEA, SULPHUR, THUJA OCC., VACCINIUM, APIS MEL., ECHINACEA, HYPERICUMNewton Laboratories, Inc.c67b3a39-ef78-5e81-e053-2a95a90a47862021-07-06WarningsExact identifier
unii: S7V92P67HO
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Arsenicum OxydatumARSENICUM OXYDATUMHahnemann Laboratories, Inc.be792c50-2d62-45ca-e053-2a95a90abd1b2021-03-26Exact identifier
unii: S7V92P67HO
Arsenicum AlbumARSENICUM ALBUMHahnemann Laboratories, Inc.be399781-affe-1cb0-e053-2995a90ad25e2021-03-23Exact identifier
unii: S7V92P67HO
HemorrhoidsELAPS CORALLINUS, AESCULUS HIPP., ALOE, ARSENICUM ALB., BRYONIA, CALC. FLUOR., CAPSICUM, COLLINSONIA, CROTALUS HORRIDUS, HAMAMELIS, HYDROFLUORICUM ACIDUM, HYPERICUM, LACHESIS, LYCOPODIUM, MILLEFOLIUM, NAJA, NUX VOM., PAEONIA, PLANTAGO, QUERCUS GLANDIUM SPIRITUS, RATANHIA, VIPERA BERUS, ECHINACEA, SOLIDAGO, URTICA UR.Newton Laboratories, Inc.c69eaaf5-b8d4-708b-e053-2a95a90ae6d12021-03-15WarningsExact identifier
unii: S7V92P67HO
HemorrhoidsELAPS CORALLINUS, AESCULUS HIPP., ALOE, ARSENICUM ALB., BRYONIA, CALC. FLUOR., CAPSICUM, COLLINSONIA, CROTALUS HORRIDUS, HAMAMELIS, HYDROFLUORICUM ACIDUM, HYPERICUM, LACHESIS, LYCOPODIUM, MILLEFOLIUM, NAJA, NUX VOM., PAEONIA, PLANTAGO, QUERCUS GLANDIUM SPIRITUS, RATANHIA, VIPERA BERUS, ECHINACEA, SOLIDAGO, URTICA UR.Newton Laboratories, Inc.c69f4926-c5c9-63a0-e053-2a95a90a2ca62021-03-15WarningsExact identifier
unii: S7V92P67HO
Candid- YADRENALINUM, CANDIDA ALBICANS, THYROIDINUM, TORULA CEREVISIAE, TRITICUM, USTILAGO MAIDIS, ANTIMON. CRUD, ARSENICUM ALB., BAPTISIA, BERBER. AQUI., BRYONIA, CALC. PHOS., CINCHONA, HELONIAS DIOICA, HYDRASTIS, IODIUM, IRIS VERSICOLOR, KALI CARB., LACHESIS, LYCOPODIUM, MERC. VIV., NAT.CARB., NAT. PHOS, NITRICUM AC., PHOSPHORUS, PODOPH. PELT, PULSATILLA, SEPIA, ECHINACEA, GINKGO, JUGLANS REGIA, LAPPA, THUJA OCC.Newton Laboratories, Inc.c68c9c20-3a07-16df-e053-2a95a90a0cbc2021-02-01WarningsExact identifier
unii: S7V92P67HO
Candid-YADRENALINUM, CANDIDA ALBICANS, THYROIDINUM, TORULA CEREVISIAE, TRITICUM, USTILAGO MAIDIS, ANTIMON. CRUD, ARSENICUM ALB., BAPTISIA, BERBER. AQUI., BRYONIA, CALC. PHOS., CINCHONA, HELONIAS DIOICA, HYDRASTIS, IODIUM, IRIS VERSICOLOR, KALI CARB., LACHESIS, LYCOPODIUM, MERC. VIV., NAT.CARB., NAT. PHOS, NITRICUM AC., PHOSPHORUS, PODOPH. PELT, PULSATILLA, SEPIA, ECHINACEA, GINKGO, JUGLANS REGIA, LAPPA, THUJA OCC.Newton Laboratories, Inc.c68ea9c3-f95c-dbcd-e053-2995a90a9aeb2021-02-01WarningsExact identifier
unii: S7V92P67HO

Reported adverse events (FAERS/openFDA)#

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