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
Label	Manufacturer	Effective date	Type
Arsenic trioxide - Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2025-02-21	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68382-997-01	Arsenic trioxide	10 mL in 1 VIAL	INJECTION, SOLUTION	10		8
68382-997-10	Arsenic trioxide	10 in 1 CARTON	INJECTION, SOLUTION	10		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-997	ARSENIC TRIOXIDE INJECTION, SOLUTION [ZYDUS PHARMACEUTICALS USA INC.]	8	Current NDC, Legacy NDC, 2 package rows	20250226_e9d27f88-de82-4379-b143-4b94b3dd8bbe.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-997-01	ML - Milliliter	68382-997	d50beb4f-4d42-4eeb-ba39-4e2af4180714	1	2019-01-24
68382-997-10	ML - Milliliter	68382-997	dc9941f9-5d66-4b48-be75-0f0dfce819af	1	2019-01-24

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 45 of 46 · 911 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mold Antigen	ALTERNARIA ALTERNATA, ASPERGILLUS FUMIGATUS, ASPERGILLUS NIGER, BOLETUS SAT, BOTRYTIS CINEREA, CLADOSPORIUM METANIGRUM, FUSARIUM OXYSPORUM, HELMINTHOSPORIUM, MUCOR MUECEDO, PULLULARIA PULLULANS, RHIZOPUS NIGRICANS, USTILAGO MAYDIS, ARSENICUM ALB, CANDIDA ALB, CARBO AN, LACHESIS, LYCOPODIUM, MERC SOLUB, NITRICUM AC, PHOSPHORUS, PULSATILLA, SEPIA, SILICEA, THUJA OCC	Zorex International	ff92e909-b5a7-417f-98a4-551f1576fd1e	2018-12-21	Warnings	Exact identifier unii: S7V92P67HO
GUNA-DERMO	ALDESLEUKIN - ARSENIC TRIOXIDE - ATROPA BELLADONNA - CANAKINUMAB - ECHINACEA ANGUSTIFOLIA - GRAPHITE - MELATONIN - PLANTAGO MAJOR - SOLANUM DULCAMARA FLOWER - SULFUR -	Guna spa	8bf717eb-fe46-4066-b124-eb715ffc1542	2018-12-21	Warnings	Exact identifier unii: S7V92P67HO
GUNA-PMS	ARSENIC TRIOXIDE - ESTRADIOL - GOLDENSEAL - LACHESIS MUTA VENOM - MAGNESIUM PHOSPHATE - MATRICARIA RECUTITA - MELATONIN - PROGESTERONE - STRYCHNOS NUX-VOMICA SEED - SULFUR - SUS SCROFA OVARY - SUS SCROFA PITUITARY GLAND -	Guna spa	86f341b1-a8f7-4833-a1be-e51610b05bcd	2018-12-21	Warnings	Exact identifier unii: S7V92P67HO
Weed Grass Antigen	ALOPECURUS PRATENSIS, ANTHOXANTHUM, CYNODON, MELILOTUS OFF, PHLEUM PRATENSE, RUMEX CRISP, SECALE CEREALE, SOLIDAGO, TRITICUM VULGARE, ALLIUM CEPA, AMBROSIA, ARSENICUM ALB, NUX VOMICA, PULSATILLA	Natural Creations, Inc	8d54c1aa-7615-419c-825f-1fc534bda608	2018-12-21	Warnings	Exact identifier unii: S7V92P67HO
Nausea CP	AETHUSA CYNAPIUM, ANTIMON TART, ARSENICUM ALB, CALC CARB, CHAMOMILLA, CINCHONA, COCCUS, CUPRUM MET, FERRUM MET, IPECAC, KREOSOTUM, LYCOPODIUM, PETROLEUM, PULSATILLA, SILICEA, SULPHUR	Natural Creations, Inc	2746cde1-577b-41d6-9f22-93d8f1a2c235	2018-12-21	Warnings	Exact identifier unii: S7V92P67HO
Stress	ARALIA QUIN, PASSIFLORA, SCUTELLARIA, VALERIANA, ARSENICUM ALB, AUR MET, CALC CARB, COFFEA CRUDA, IGNATIA, KALI PHOS, LYCOPUS, PHOSPHORUS, STAPHYSAGRIA	Zorex International	d0527396-7b7f-4252-be0f-d3aa74c25e0e	2018-12-21	Warnings	Exact identifier unii: S7V92P67HO
Dust Mix Antigen	ANTIMON TART, ARSENICUM ALB, BLATTA OR, BROMIUM, CALC CARB, CIMEX, DROSERA, HEPAR SULPH CALC, ICTODES FOETIDA, LYCOPODIUM, PHOS, PULSATILLA, SILICEA TERRA, TABACUM FUMUS	Natural Creations, Inc	8dab4b4a-6fa8-4258-adc1-f8c634e2030b	2018-12-21	Warnings	Exact identifier unii: S7V92P67HO
Nasal Decongestant	CAMELLIA SINENSIS, EPHEDRA VULGARIS, BELLADONNA, ARSENICUM ALBUM, CINNABARIS, KALI BICHROMICUM, PULSATILLA, SEPIA, CALCAREA CARBONICA, MERCURIUS SOLUBILIS, SULPHUR	Natural Creations, Inc	938a25f8-e854-4537-a04d-5e2276199f5c	2018-12-21	Warnings	Exact identifier unii: S7V92P67HO
Dynamic Eyewash with Eyecup	WATER	Dynamic Safety International	7d3af0f4-0e1f-9ea5-e053-2991aa0af7a2	2018-12-17	Warnings	Exact identifier unii: 059QF0KO0R
Biological Complex III	ANTHRACINUM, ARSENICUM ALBUM, BOTULINUM, CALCAREA HYPOPHOSPHOROSA, COXIELLA BURNETII, DYSENTERY BACILLUS, FRANCISELLA TULARENSIS, GAERTNER BACILLUS, KALI SULPHURICUM, LAC CANINUM, MALARIA OFFICINALIS, MUTABILE BACILLUS, PERTUSSINUM, PESTINUM, PYROGENIUM, TYPHOID FEVER,	Deseret Biologicals, Inc.	903c680c-c7fc-4671-b809-1b81bd4c6be4	2018-10-24	Warnings	Exact identifier unii: S7V92P67HO
Nightshade Antigen	CAPSICUM ANNUUM, SOLANUM TUBEROSUM, TABACUM, LYCOPERSICUM ESCULENTUM, SOLANUM MELONGENA, ALUMINUM METALLICUM, ARSENICUM ALBUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS)	BioActive Nutritional, Inc.	47571afb-fa53-4c5b-ba35-8f0609a2bd75	2018-09-25	Warnings	Exact identifier unii: S7V92P67HO
Bio Rock Water	ROCK WATER	BioActive Nutritional, Inc.	178bd16d-0d4f-49d8-866b-8ab3a3c6889d	2018-07-30	Warnings	Exact identifier unii: 059QF0KO0R
Additox	TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM	BioActive Nutritional, Inc.	319ee2fe-58e3-495e-bf0d-df201f6fbb1c	2018-07-18	Warnings	Exact identifier unii: S7V92P67HO
Diathesis I	MANGANUM METALLICUM, GERMANIUM SESQUIOXIDE, FEL TAURI, HEPAR SUIS, GINKGO BILOBA, CYSTEINUM, MANGANESE GLUCONATE, ALPHA-KETOGLUTARICUM ACIDUM, ARSENICUM ALBUM, FUMARICUM ACIDUM, PHOSPHORUS, SODIUM OXALATE, SULPHUR	BioActive Nutritionals, Inc.	e8c3b763-7d54-48b1-8db8-a5b47ce7aeeb	2018-07-13	Warnings	Exact identifier unii: S7V92P67HO
Free Radical	TRITICUM AESTIVUM, ALFALFA, FUCUS VESICULOSUS, LAMINARIA DIGITATA, NASTURTIUM AQUATICUM, ORYZA SATIVA, RAPHANUS SATIVUS, SYMPHYTUM OFFICINALE, HORDEUM VULGARE, ASPARAGUS OFFICINALIS, MANGANESE GLUCONATE, FERRUM PHOSPHORICUM, ARNICA MONTANA, CUPRUM METALLICUM, UBIDECARENONUM, ALPHA-KETOGLUTARICUM ACIDUM, GLYOXAL TRIMER DIHYDRATE, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, BORON, BROMIUM	BioActive Nutritional, Inc.	e09f8fbb-e8c7-4c1b-994a-60f8fef79c0a	2018-05-22	Warnings	Exact identifier unii: S7V92P67HO
Diathesis II	GERMANIUM SESQUIOXIDE, CUPRUM METALLICUM, MANGANUM METALLICUM, INTESTINE (SUIS), LUNG (SUIS), CYSTEINUM, MANGANESE GLUCONATE, ALPHA-KETOGLUTARICUM ACIDUM, ARSENICUM ALBUM, CALCAREA CARBONICA, FUMARICUM ACIDUM, NATRUM OXALACETICUM, PHOSPHORUS	BioActive Nutritional, Inc.	240a5573-0603-4201-ab11-39b894b8794e	2017-12-27	Warnings	Exact identifier unii: S7V92P67HO
Homeoplex G	GENTIANA LUTEA, ARSENICUM ALBUM, CINCHONA OFFICINALIS, COLOCYNTHIS, NUX VOMICA, PHOSPHORUS, SMALL INTESTINE (SUIS)	Supplement Clinic, LLC.	4119921d-6c71-41ab-98b6-b86c820eb8bc	2017-11-01	Warnings	Exact identifier unii: S7V92P67HO
Homeoplex D	GLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,	Supplement Clinic, LLC.	cd6b48ab-3566-484d-8deb-15ef6f8e7e8f	2017-11-01	Warnings	Exact identifier unii: S7V92P67HO
Homeoplex B	ARSENICUM ALBUM, CALCAREA CARBONICA , IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA, STAPHYSAGRIA	Supplement Clinic, LLC.	e9a9c58e-1b70-4ac8-9d9c-108c628d7664	2017-10-31	Warnings	Exact identifier unii: S7V92P67HO
Spleen-Pro T018	SPLEEN (SUIS), ARSENICUM ALBUM, CARBO VEGETABILIS, CEANOTHUS AMERICANUS, CHININUM SULPHURICUM, IGNATIA AMARA, IODIUM, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, PHOSPHORUS	Guangzhou Renuma Medical Systems Co., Ltd	bc2b70bd-2a4a-46fb-b3d8-d69b61056b89	2017-10-26	Warnings	Exact identifier unii: S7V92P67HO

Reported adverse events (FAERS/openFDA)#

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