FDA.reportPublic FDA data

NDC 49315-005-01 - 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
49315-005
Requested NDC
49315-005-01
Package NDCs from labels
49315-005-01, 49315-005-10
Manufacturer
Zydus Lifesciences Limited
Effective date
2022-11-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Arsenic trioxide - Zydus Lifesciences LimitedZydus Lifesciences Limited2022-11-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49315-005-01Arsenic trioxide10 mL in 1 VIALINJECTION, SOLUTION103
49315-005-10Arsenic trioxide10 in 1 CARTONINJECTION, SOLUTION103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49315-005ARSENIC TRIOXIDE INJECTION, SOLUTION [ZYDUS LIFESCIENCES LIMITED]3Current NDC, Legacy NDC, 2 package rows20221108_25e8295c-b5d9-4322-a093-d907ab1d1d35.zip

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 17 of 46 · 911 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products BM197RHUS TOX, BRYONIA, COLOCYNTHIS, ARSENICUM ALBUM, HYPERICUM, CHAMOMILLA, GNAPHALLIUMBestmade Natural Products2ef5a641-e45a-bafc-e063-6394a90a1b5d2025-02-25WarningsExact identifier
unii: S7V92P67HO
Bestmade Natural Products BM201ARS ALB, BRYONIA, CHAMOMILLA, COLOCYNTHIS, NUX VOMICA, RHUS TOXBestmade Natural Products2ef7632e-dc8a-6b21-e063-6294a90ac2dd2025-02-25WarningsExact identifier
unii: S7V92P67HO
Arsenic trioxideARSENIC TRIOXIDEZydus Pharmaceuticals USA Inc.e9d27f88-de82-4379-b143-4b94b3dd8bbe2025-02-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA206228
rxcui: 829926
unii: S7V92P67HO
Bestmade Natural Products BM193APIS MELL, ARS ALB, BERB VULG, HELLEBORE, LYCOPODIUMBestmade Natural Products2ea985f7-e36f-97cd-e063-6294a90aa0a72025-02-21WarningsExact identifier
unii: S7V92P67HO
Arsenic trioxideARSENIC TRIOXIDEZydus Pharmaceuticals USA Inc.e1ad5d87-e65e-402f-86b5-e641fc4e61ab2025-02-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA206228
unii: S7V92P67HO
Bestmade Natural Products BM176ACONITE NAP, ARS ALB, BELLADONNA, BRYONIA ALBA, CHAMOMILLA, LEDUM PAL, SULPHURBestmade Natural Products2e7e7a3c-5b60-20e2-e063-6294a90ae2892025-02-19WarningsExact identifier
unii: S7V92P67HO
Bestmade Natural Products BM144APIS MELL, ARSENIC ALB, DOLICHOS PRU, JUNIPERUS COM, KALI CARB, ROSMARINUS OFF, SOLIDAGO VIRG, STIGMATA MAYBestmade Natural Products2e68bbcf-08ea-67ef-e063-6294a90af2a82025-02-18WarningsExact identifier
unii: S7V92P67HO
Bestmade Natural Products BM150ARALIA RAC, ARSENIC ALB, CACTUS GR, CUPRUM ACET, DROSERA, GLYCYRRHIZA GLAB, JUSTICIA ADHATODA, LOBELIA INFBestmade Natural Products2e6a1412-a76a-6716-e063-6294a90a84a92025-02-18WarningsExact identifier
unii: S7V92P67HO
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
Arsenicum Album 200ckARSENIC TRIOXIDESEVENE USAc8d6dcbf-a5a9-5231-e053-2a95a90a73542025-02-11WarningsExact identifier
unii: S7V92P67HO
Stage Fright-FearACONITUM NAP., ANACARDIUM, ARG. NIT., ARSENICUM ALB., CYPRIPEDIUM, GELSEMIUM, IGNATIA, KALI CARB., LYCOPODIUM, NAT.MUR., PHOS., SAMBUCUS NIG., SEPIA, STAPHYSAG., STRAMONIUM, TARENTULA HISPANA, THERIDION, PASSIFLORA, VALERIANANewton Laboratories, Inc.2df84360-dfff-9851-e063-6394a90ad7902025-02-11WarningsExact identifier
unii: S7V92P67HO
Sciatica-Nerve CareACONITUM NAP., AMMONIUM BENZOICUM, ARSENICUM ALB., BENZOICUM ACIDUM, BRYONIA, CAUSTICUM, CINCHONA, COLCHICUM, GNAPHALIUM POLYCEPHALUM, IRIS VERSICOLOR, KALI IOD., LEDUM, LITHIUM CARB., NUX VOM., PHYTOLACCA, RHUS TOXICODERON, RUTA, SAMBUCUS NIG., STRYCHNINUM, HYPERICUM, URTICA URNewton Laboratories, Inc.9cbd3056-3c1a-916d-e053-2a95a90aa2432025-02-10WarningsExact identifier
unii: S7V92P67HO
Sciatica-Nerve CareACONITUM NAP., AMMONIUM BENZOICUM, ARSENICUM ALB., BENZOICUM ACIDUM, BRYONIA, CAUSTICUM, CINCHONA, COLCHICUM, GNAPHALIUM POLYCEPHALUM, IRIS VERSICOLOR, KALI IOD., LEDUM, LITHIUM CARB., NUX VOM., PHYTOLACCA, RHUS TOXICODERON, RUTA, SAMBUCUS NIG., STRYCHNINUM, HYPERICUM, URTICA URNewton Laboratories, Inc.9cbda496-ef30-18af-e053-2995a90a23212025-02-10WarningsExact identifier
unii: S7V92P67HO
RosaceaECHINACEA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, ARSENICUM BROMATUM, CARBO ANIMALIS, CAUSTICUM, HYDROCOTYLE ASIATICA, KALI BROMATUM, KALI IODATUM, KREOSOTUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PETROLEUM, RHUS TOXICODENDRON, SEPIA, SULPHURNewton Laboratories, Inc.9caca164-0e81-7ed3-e053-2995a90a12442025-02-10WarningsExact identifier
unii: S7V92P67HO
Teeth-GumsCHAMOMILLA, ECHINACEA, ACONITUM NAPELLUS, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CALENDULA OFFICINALIS, CHAMOMILLA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, MERCURIUS VIVUS, MYRRHA, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PLANTAGO MAJOR, RHUS TOXICODENDRON, SILICEA, STAPHYSAGRIANewton Laboratories, Inc.9d27b1e4-a966-5495-e053-2a95a90a965b2025-02-10WarningsExact identifier
unii: S7V92P67HO
Tobacco WithdrawalARSENICUM ALB., BENZOICUM ACIDUM, BERBER. VULG., BRYONIA, CALADIUM SEGUINUM, CANTHARIS, CEANOTHUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA, DAPHNE INDICA, IGNATIA, IRIS VERSICOLOR, LYCOPODIUM, NICOTINUM, NUX VOM., RHUS TOXICODENDRON, SCUTELLARIA LATERIFLORA, TABACUM, ECHINACEA, TARAXACUM, VALERIANANewton Laboratories, Inc.9d38fd5a-1657-11e5-e053-2a95a90a47ee2025-02-10WarningsExact identifier
unii: S7V92P67HO
Teeth-GumsCHAMOMILLA, ECHINACEA, ACONITUM NAPELLUS, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CALENDULA OFFICINALIS, CHAMOMILLA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, MERCURIUS VIVUS, MYRRHA, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PLANTAGO MAJOR, RHUS TOXICODENDRON, SILICEA, STAPHYSAGRIANewton Laboratories, Inc.9d363a40-a17b-2b6f-e053-2a95a90a33842025-02-10WarningsExact identifier
unii: S7V92P67HO
Tobacco WithdrawalARSENICUM ALB., BENZOICUM ACIDUM, BERBER. VULG., BRYONIA, CALADIUM SEGUINUM, CANTHARIS, CEANOTHUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA, DAPHNE INDICA, IGNATIA, IRIS VERSICOLOR, LYCOPODIUM, NICOTINUM, NUX VOM., RHUS TOXICODENDRON, SCUTELLARIA LATERIFLORA, TABACUM, ECHINACEA, TARAXACUM, VALERIANANewton Laboratories, Inc.9d399697-69dc-217d-e053-2a95a90a65e42025-02-10WarningsExact identifier
unii: S7V92P67HO
VitalityECHINACEA, LAPPA MAJOR, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, ADRENALINUM, ALOE, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, BRYONIA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, DIGITALIS PURPUREA, FERRUM METALLICUM, GLONOINUM, HYDROCOTYLE ASIATICA, IODIUM, IRIS VERSICOLOR, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, THUJA OCCIDENTALIS, THYROIDINUM, GLYCYRRHIZA GLABRANewton Laboratories, Inc.9d3a6b0e-a23f-9f2d-e053-2995a90a75cf2025-02-10WarningsExact identifier
unii: S7V92P67HO

Reported adverse events (FAERS/openFDA)#

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