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 44 of 46 · 911 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Blues - Mood - Emotions	ANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARG. NIT., ARSENICUM ALB., BERBER. AQUI., CAPSICUM , CINCHONA, DIGITALIS, GELSEMIUM, HYPERICUM, IGNATIA, IODIUM, KALI BROM., KALI CARB., MAG. PHOS., NAT. CARB., NAT. MUR., PHOSPHORUS, SALIX NIGRA, SANGUINARIA, SEPIA, STRAMONIUM, ECHINACEA, GINKGO	Newton Laboratories, Inc.	798ab5a2-7464-8e9d-e053-2a91aa0acc98	2020-11-24	Warnings	Exact identifier unii: S7V92P67HO
Bowel - Digestive Care	BISMUTHUM METALLICUM, ANTIMON.CRUD., ARG. NIT., ARSENICUM ALB., BAPTISIA, BRYONIA, CHAMOMILLA, CINCHONA, IRIS VERSICOLOR, KALI BIC., LACHESIS, LYCOPODIUM, MAG. CARB., NUX VOM., PHOSPHORUS, PODOPH. PELT., PULSATILLA, RAPHANUS, RHUS TOXICODENDRON, TABACUM, VERBASCUM, ZINGIBER, ECHINACEA, JUGLANS REGIA.	Newton Laboratories, Inc.	907fafa5-2f75-f11d-e053-2a95a90a1fb8	2020-11-24	Warnings	Exact identifier unii: S7V92P67HO
Cold Hands - Feet	HISTAMINUM HYDROCHLORICUM,THYROIDINUM, ACONITUM NAP., ARSENICUM ALB., BRYONIA, CACTUS, CALC. FLUOR., CEANOTHUS, CINCHONA, CONVALLARIA, DIGITALIS, GELSEMIUM, GLONOINUM, HYDROCOYLE, KALI CARB., LACHESIS, NAJA, NAT CARB., NAT MUR., NUX VOM., PHOSPHORUS, PULLSATILLA, RHUS TOXICODENDRON, STROPHANTHUS HISPIDUS, SULPHUR, ECHINACEA	Newton Laboratories, Inc.	7a2b4f28-2128-a8b2-e053-2a91aa0a2402	2020-11-24	Warnings	Exact identifier unii: S7V92P67HO
Post - Vaccination	INFLUENZINUM, 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, HYPERICUM	Newton Laboratories, Inc.	9042b7ad-15ed-0e81-e053-2a95a90afe28	2020-11-23	Warnings	Exact identifier unii: S7V92P67HO
Post-Vaccination	INFLUENZINUM, 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, HYPERICUM	Newton Laboratories, Inc.	90bb15e5-3d9d-e2e2-e053-2995a90a85ac	2020-11-23	Warnings	Exact identifier unii: S7V92P67HO
GUNA ALLERGY	ADRENALINUM - ALLIUM CEPA - AMMONIUM CARBONICUM - APIS MELLIFICA - ARGENTUM NITRICUM - ARSENICUM ALBUM - CUPRUM ACETICUM - GALPHIMIA GLAUCA - GLANDULA SUPRARENALIS SUIS - HISTAMINUM HYDROCHLORICUM - LUFFA OPERCULATA - MATRICARIA CHAMOMILLA - MUCOSA NASALIS SUIS - NATRUM MURIATICUM - SABADILLA - SCILLA MARITIMA -	Guna spa	ae6bd80d-2c70-1a3f-e053-2a95a90a2652	2020-10-23	Warnings	Exact identifier unii: S7V92P67HO
Supreme	ABROTANUM, ANACARDIUM ORIENTALE, ARSENICUM ALBUM, BARYTA MURIATICA, HELLEBORUS NIGER, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NICOTINAMIDUM, SECALE CORNUTUM, THYMUS (BOVINE), THYROIDINUM (BOVINE), CALCAREA CARBONICA, CALCAREA PHOSPHORICA, HYPOTHALAMUS SUIS, PITUITARUM POSTERIUM (BOVINE), SILICEA	BOUARI GROUP, LLC dba WEIGHT LOSS COMPANY, THE	72c4679b-aa97-4888-9178-581d0f99c0b6	2020-09-11	Warnings	Exact identifier unii: S7V92P67HO
Bach Original Flower Remedies	WATER	Nelson Bach USA Limited	09c76050-42c5-4403-865c-a1f6f668d9c0	2020-06-15	Warnings	Exact identifier unii: 059QF0KO0R
BronCare	ECHINACEA, LAPPA, RUMEX CRISP., ANTIMON. TART., ARSENICUM ALB., BRYONIA, CAMPHORA, CHELIDONIUM MAJ., CINCHONA, DROSERA, EUCALYPTUS, HEPAR SULPH. CALC., HISTAMINUM HYDROCHLORICUM, IPECAC., KALI BIC., KALI CARB., KALI IOD., LYCOPODIUM, MYRRHA, NAT. SULPHURICUM, NUX VOM., PHOS., PULSATILLA, SAINGUINARIA, SPONGIA, STANNUM MET., TUSSILAGO FAR., VERBASCUM, INFLUENZINUM	Newton Laboratories, Inc.	a5281807-675f-07f7-e053-2995a90a3a8a	2020-05-18	Warnings	Exact identifier unii: S7V92P67HO
Hay Fever	APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, ALFALFA, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, AMMONIUM CARBONICUM, ARALIA RACEMOSA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, BELLIS PERENNIS, BERBERIS VULGARIS, BRYONIA, CALLUNA VULGARIS, FLOS, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CISTUS CANADENSIS, DROSERA, DULCAMARA, EUPATORIUM PERFOLIATUM, EUPHRASIA OFFICINALIS, FAGUS SYLVATICA, FRAXINUS AMERICANA, GELSEMIUM SEMPERVIRENS	Newton Laboratories, Inc.	a6045b91-d361-2731-e053-2a95a90a9772	2020-05-18	Warnings	Exact identifier unii: S7V92P67HO
Sterile Water	WATER	Baxter Healthcare Company	8bcf5572-49e1-4302-9522-56f57904cb4a	2019-12-29	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Kids Relief	ARSENICUM ALBUM, KALI PHOSPHORICUM, MERCURIS SOLUBILIS, NATRUM SULPHURICUM, HEPAR SULPHURIS CALCAREUM, ARUM TRIPHYLLUM	Homeolab International (Canada) inc	18a6f6d4-cdfd-4bf7-8cb2-831033c1d965	2019-10-23	Warnings	Exact identifier unii: S7V92P67HO
Mercurius Combination 9233	MERCURIUS COMBINATION	Professional Complementary Health Formulas	42e1d05d-c0ab-48f3-94d2-1a1d3e1d2944	2019-08-15	Warnings	Exact identifier unii: S7V92P67HO
Kids Relief	PULSATILLA, ALLIUM CEPA, ARSENICUM ALBUM, NUX VOMICA, EUPHRASIA OFFINALIS, SABADILLA, ARALIA RACEMOSA, CUPRUM METALLICUM	Homeolab International (Canada) inc	7978fb75-fac9-480d-830c-c8c09ff29be1	2019-07-25	Warnings	Exact identifier unii: S7V92P67HO
Kids Relief	PULSATILLA, ALLIUM CEPA, ARSENICUM ALBUM, NUX VOMICA, EUPHRASIA OFFINALIS, SABADILLA, STICTA PULMONARIA, ARAILA RACEMOSA, CUPRUM METALLICUM	Homeolab International (Canada) inc	ba120c26-1e84-48b9-b38a-df5aa75ea6ce	2019-07-16	Warnings	Exact identifier unii: S7V92P67HO
Kids Relief	FERRUM PHOSPHORICUM, CAPSICUM ANNUUM, PYROGENIUM, ARSENICUM ALBUM	Homeolab International (Canada) inc	ebf8c279-35a4-4daf-bc27-b1fdbcd0a25c	2019-07-16	Warnings	Exact identifier unii: S7V92P67HO
Eczema Relief	ANTIMONY TRISULFIDE, APIS MELLIFERA, ARSENIC TRIOXIDE, ATROPA BELLADONNA, GRAPHITE, ARCTIUM LAPPA FRUIT, KEROSENE, SOLIDAGO CANADENSIS WHOLE, VIOLA TRICOLOR	Homeocare Laboratories	1bfea3be-5909-4aa3-9ec3-05b4db2dd69b	2018-12-31	Warnings	Exact identifier unii: S7V92P67HO
Gastrozen	COFFEA TOSTA, GLYCYRRHIZA, PHYTOLACCA, TARAXACUM, HYDRASTIS, ARSENICUM ALB, GELSEMIUM, MERC SOLUB, NITRICUM AC, NUX VOM, PETROLEUM, PHOSPHORICUM AC, PHOSPHORUS, BROMIUM, CADMIUM SULPHURICUM, CINCHONA, CONIUM, HYDROGEN, IODIUM, LACHESIS, PULSATILLA, SILICEA, SULPHURICUM AC	Natural Creations, Inc	98dd756f-6774-47c3-bdfb-deff82fb801d	2018-12-21	Warnings	Exact identifier unii: S7V92P67HO
H.M.D.	ALLIUM SAT, AVENA, BERBER VULG, LAPPA, PHYTOLACCA, SOLIDAGO, ALUMINA, ARG NIT, BARYTA CARB, BERYLLIUM, CADMIUM MET, CURPRUM MET, FLUORICUM ACIDUM, INDIUM, IODIUM, LITHIUM CARB, MERC SOLUB, NICCOLUM CARB, NITROGENUM OXYGENATUM, PLUMB MET, SELENIUM, STRONTIUM CARB, TITANIUM, ARSENICUM ALB, NAT MUR, NUX VOM	Zorex International	8c53091a-904d-4756-93e4-17143c5b48e9	2018-12-21	Warnings	Exact identifier unii: S7V92P67HO
Imucode	ASTRAGALUS, HYDRASTIS, ADRENALINUM, THYROIDINUM, PITUITARUM POSTERIUM, ARSENICUM ALB, BAPTISIA, BARYTA CARB, BARYTA MUR, BROMIUM, CANDIDA ALB, CEANOTHUS, CHININUM SULPH, CONIUM, HEPAR SULPH CALC, IGNATIA, INDIUM, IODIUM, MERC SOLUB, PHYTOLACCA, SULPHUR	Natural Creations, Inc	be30901c-0673-4af0-8128-83ed59ff04b1	2018-12-21	Warnings	Exact identifier unii: S7V92P67HO

Reported adverse events (FAERS/openFDA)#

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