FDA.reportPublic FDA data

NDC 54879-027-10 - 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
54879-027
Requested NDC
54879-027-10
Package NDCs from labels
54879-027-10, 54879-027-11
Manufacturer
STI Pharma LLC
Effective date
2022-11-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Arsenic Trioxide - STI Pharma LLCSTI Pharma LLC2022-11-17HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54879-027-112025-04-21C16284748780-1ab0e2407-30bb-f274-e053-dbdaa90a6471Arsenic trioxide injection, for intravenous administration These highlights do not include all the information needed to use Arsenic Trioxide safely and effectively. See full prescribing information for Arsenic Trioxide . Initial U.S. Approval: 2000
54879-027-112024-01-30C16284748780-1ab0e2407-30bb-f274-e053-dbdaa90a6471Arsenic trioxide injection, for intravenous administration These highlights do not include all the information needed to use Arsenic Trioxide safely and effectively. See full prescribing information for Arsenic Trioxide . Initial U.S. Approval: 2000
54879-027-112020-07-22C16284748780-1ab0e2407-30bb-f274-e053-dbdaa90a6471Arsenic trioxide injection, for intravenous administration These highlights do not include all the information needed to use Arsenic Trioxide safely and effectively. See full prescribing information for Arsenic Trioxide . Initial U.S. Approval: 2000

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 20 of 45 · 890 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
D-101WORMWOOD, ARSENIC TRIOXIDE, GARLIC, AMOEBA PROTEUS, AMMONIUM PHOSPHATE, DIBASIC, ACTIVATED CHARCOAL, CINCHONA OFFICINALIS BARK, AND VERATRUM ALBUM ROOTDNA Labs, Inc.d829481b-110e-4be7-87ef-910bd248454c2025-01-13WarningsExact identifier
unii: S7V92P67HO
D-71ACONITUM NAPELLUS, ARSENIC TRIOXIDE, CITRULLUS COLOCYNTHIS FRUIT PULP, PSEUDOGNAPHALIUM OBTUSIFOLIUM, AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEDNA Labs, Inc.478668a3-bf20-4205-a81a-2f9e4565f8762025-01-13WarningsExact identifier
unii: S7V92P67HO
D-112LACHESIS MUTA VENOM, SILICON DIOXIDE, SODIUM CHLORIDE, RANUNCULUS BULBOSUS, ACONITUM NAPELLUS, ACTIVATED CHARCOAL, NITROGLYCERIN, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ANEMONE PRATENSIS, PLANTAGO MAJOR, ARSENIC TRIOXIDE, AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEDNA Labs, Inc.8d517ef2-3a1e-4393-9452-a4cd0f0a3bca2025-01-13WarningsExact identifier
unii: S7V92P67HO
D-114ALUMINUM METALLICUM, AILANTHUS, BAPTISIA TINCTORIA, FRAGARIA VESCA, YOSCYAMUS NIGER, MURIATICUM ACIDDNA Labsf6f7d369-64ef-0ed9-e053-6294a90a40fa2025-01-13WarningsExact identifier
unii: QTT17582CB
D-65ARSENIC TRIOXIDE, BERBERIS AQUIFOLIUM ROOT BARK, OYSTER SHELL CALCIUM CARBONATE, CRUDE, GRAPHITE, CENTELLA ASIATICA, AND SODIUM CHLORIDEDNA Labs, Inc.94d4b66a-f995-4516-bdcf-2152c2a624dd2025-01-13WarningsExact identifier
unii: S7V92P67HO
D134BLACK COHOSH, BRYONIA ALBA WHOLE, TOXICODENDRON PUBESCENS WHOLE, ARNICA MONTANA, CAUSTICUM, FERROSOFERRIC PHOSPHATE, SODIUM SULFATE ANHYDROUS, STRYCHNOS NUX-VOMICA SEED, RHODODENDRON AUREUM WHOLE, CITRULLUS COLOCYNTHIS WHOLE, SOLANUM DULCAMARA WHOLE, KALMIA LATIFOLIA WHOLE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, ARSENIC TRIOXIDE, AND TRIBASIC CALCIUM PHOSPHATEDNA Labs, Inc.a1d4d74a-75ca-45f8-8787-7ac6aa7269322025-01-13WarningsExact identifier
unii: S7V92P67HO
D-105BOS TAURUS ADRENAL GLAND, APIS MELLIFERA, ARSENIC TRIOXIDE, LYTTA VESICATORIA, BOS TAURUS LYMPH VESSEL, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, URTICA URENS, PYRIDOXINE HYDROCHLORIDE, AND ASCORBIC ACIDDNA Labs, Inc.1535cb47-b155-4ac4-af7d-b22ac83254032025-01-13WarningsExact identifier
unii: S7V92P67HO
D-137APIS MELLIFERA, ARSENIC TRIOXIDE, BAPTISIA TINCTORIA, ATROPA BELLADONNA, ECHINACEA PURPUREA, EUPATORIUM PERFOLIATUM WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, CALCIUM SULFIDE, RANCID BEEF, SULFUR, SILICON DIOXIDE, AND THUJA OCCIDENTALIS LEAFY TWIGDNA Labs, Inc.240d03c0-957b-48e4-9bab-43f9e6b8fb422025-01-13WarningsExact identifier
unii: S7V92P67HO
D-154ANAMIRTA COCCULUS, ARABICA COFFEE BEAN, ARSENICUM ALBUM, CALCAREA CARBONICA, GRAPHITE, NUX VOMICA, PHOSPHORUS, POTASSIUM CARBONATE, SULFURDNA Labsf53e05de-043c-4eb4-e053-2995a90ad9cf2025-01-13WarningsExact identifier
unii: S7V92P67HO
D-115CAUSTICUM, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, IODINE, ARSENIC TRIOXIDE, BARIUM CARBONATE, ECHINACEA ANGUSTIFOLIA, ALUMINUM, ANTIMONY TRISULFIDE, STRYCHNOS NUX-VOMICA SEED, DELPHINIUM STAPHISAGRIA SEED, SULFURIC ACID, CALCIUM SULFIDE, AND SILVER NITRATEDNA Labs, Inc.247a9133-fe4b-42a0-b3f3-7cb62eaec8c42025-01-13WarningsExact identifier
unii: S7V92P67HO
D-136SOMATROPIN, LONG-(ARG3)INSULIN-LIKE GROWTH FACTOR-I, ARSENIC TRIOXIDE, SAW PALMETTO, PLATINUM, OYSTER SHELL CALCIUM CARBONATE, CRUDE, BOS TAURUS ADRENAL CORTEX, BOS TAURUS PITUITARY GLAND, POSTERIOR, THYROID, UNSPECIFIED, AND BOS TAURUS HYPOTHALAMUSDNA Labs, Inc.d94be950-ce16-4c55-bbb3-af3f9c4d29d62025-01-13WarningsExact identifier
unii: S7V92P67HO
D-152ARSENIC TRIOXIDE, STRYCHNOS NUX-VOMICA SEED, ACONITUM NAPELLUS, GOLD, CAUSTICUM, HYOSCYAMUS NIGER LEAF, LACHESIS MUTA WHOLE, DAPHNE MEZEREUM WHOLE, ANEMONE PULSATILLA, SULFUR, AND VERATRUM VIRIDE WHOLEDNA Labs, Inc.e8968153-24c0-474d-8f4d-493481f442062025-01-13WarningsExact identifier
unii: S7V92P67HO
D-155ARSENICUM ALBUM, CARBO VEGETABILIS, IPECACUANHA, NUX VOMICA, SULFURDNA Labsf5512f34-08f0-b0f6-e053-2a95a90ab5bd2025-01-13WarningsExact identifier
unii: S7V92P67HO
Arsenicum album 30ARSENICUM ALBUM 30Uriel Pharmacy Inc.a4c70f5c-47c9-4e94-b9cc-1db1db61790e2025-01-10WarningsExact identifier
unii: S7V92P67HO
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
N-20STRYCHNOS NUX-VOMICA SEED, ARSENIC TRIOXIDE, ACTIVATED CHARCOAL, SILVER NITRATE, MARSDENIA CUNDURANGO WHOLE, TRIPE, AND SUS SCROFA DUODENUMDNA Labs, Inc.14304769-22a0-4c0c-a79c-e70e1bc75cb62025-01-09WarningsExact identifier
unii: S7V92P67HO
N-23ANEMONE PULSATILLA, PHOSPHORUS, SILICON DIOXIDE, NITRIC ACID, ARSENIC TRIOXIDE, TOXICODENDRON PUBESCENS WHOLE, AND BOS TAURUS HYPOTHALAMUSDNA Labs, Inc.b6365b49-06fb-4692-96f7-a5097b70bc912025-01-09WarningsExact identifier
unii: S7V92P67HO
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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