FDA.reportPublic FDA data

NDC 80425-0366-01 - Tobramycin and Dexamethasone

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
80425-0366
Requested NDC
80425-0366-01
Package NDCs from labels
80425-0366-1, 80425-0366-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tobramycin and Dexamethasone - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0366-1Tobramycin and Dexamethasone5 mL in 1 BOTTLESUSPENSION/ DROPS52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0366TOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [ADVANCED RX OF TENNESSEE, LLC]2Current NDC, 1 package rows20250101_09315f0b-f15a-30d5-e063-6394a90ac8dd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0366-1ML - Milliliter80425-0366dda8d509-96d2-4b7a-8923-64f4cf3c30e712023-12-05

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 100 of 132 · 2,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Ecolab Inc.BENZALKONIUM CHLORIDEEcolab Inc.7873638a-afd7-4b55-bcc5-0e893a437fb32024-05-31WarningsExact identifier
unii: F5UM2KM3W7
Ciprofloxacin and DexamethasoneCIPROFLOXACIN AND DEXAMETHASONEDr. Reddy's Laboratories, Inc.f07cf7d6-c233-884e-342d-c6c8cd2c84382024-05-30Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Liver DrainageCHELIDONIUM MAJUS, CARDUUS MARIANUS, SCHISANDRA CHINENSIS, TARAXACUM OFFICINALE, BERBERIS VULGARIS, RAPHANUS SATIVUS, VISCUM ALBUM, CHROMIUM PICOLINATE, COBALT GLUCONATE, COPPER GLUCONATE, MAGNESIUM GLUCONATE, NATRUM SULPHURICUM, PTELEA TRIFOLIATE, SARCOLACTICUM ACIDUM, SULPHUR IODATUM, CARBOLICUM ACIDUM, CICHORIUM INTYBUS, FLOS, GALLBLADDER (SUIS), HEPAR SUIS, NUX VOMICA, PANCREAS SUIS, VANADIUM METALLICUM, VERBENA OFFICINALIS, FLOS, PICRORHIZA KURROADeseret Biologicals, Inc.1857dee7-4227-4fa3-9d70-1f02264392902024-05-29WarningsExact identifier
unii: 0YPR65R21J
DexamethasoneDEXAMETHASONEBryant Ranch Prepackc75360d3-2e4f-4620-a8f0-db28b1aa704b2024-05-28Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Mentox HPAURUM METALLICUM, BARYTA CARBONICA, CALCAREA CARBONICA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUSEnergique, Inc.ebb23637-4931-4563-ab30-99bea02765802024-05-28WarningsExact identifier
unii: 451W47IQ8X
Liver DrainageBERBERIS VULGARIS, CARBOLICUM ACIDUM, CARDUUS MARIANUS, CHELIDONIUM MAJUS, CHROMIUM PICOLINATE, CICHORIUM INTYBUS, FLOS, COBALT GLUCONATE, COPPER GLUCONATE, GALLBLADDER (SUIS), HEPAR SUIS, MAGNESIUM GLUCONICUM DIHYDRICUM, NATRUM SULPHURICUM, NUX VOMICA, PANCREAS SUIS, PICRORHIZA KURROA, PTELEA TRIFOLIATE, RAPHANUS SATIVUS, SARCOLACTICUM ACIDUM, SCHISANDRA CHINENSIS, SULPHUR, TARAXACUM OFFICINALE, VANADIUM METALLICUM, VERBENA OFFICINALIS, FLOS, VISCUM ALBUMDeseret Biologicals, Inc.bd3151b4-fe34-4288-b8e0-ba8850f4b39b2024-05-28WarningsExact identifier
unii: 0YPR65R21J
Potassium Chloride in Lactated Ringers and DextrosePOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATEFresenius Kabi USA, LLCdbed53b7-0109-4561-8342-0178ec8c64b02024-05-22Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATEFresenius Kabi USA, LLC1b912c7e-f005-4af4-b683-0834409642492024-05-22Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLC239a5af1-7498-480f-862c-ab7c3d89d1832024-05-21Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEBecton Dickinson and Companyebc8b008-a8b3-4c41-89e4-b413f7aab89f2024-05-21Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.9d5dea47-5103-21a3-e053-2995a90aee782024-05-20WarningsExact identifier
unii: 451W47IQ8X
ColoparCOLON (SUIS), ARSENICUM ALBUM, CAUSTICUM, IGNATIA AMARA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SEPIA, SILICEA, THUJA OCCIDENTALISEnergique, Inc.c47d7203-abcd-4ae5-bf9b-5df07e07d3c12024-05-20WarningsExact identifier
unii: 451W47IQ8X
SAFLY BurnLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.3aca2568-d10f-4b14-861b-6c741c1068292024-05-17WarningsExact identifier
unii: F5UM2KM3W7
Safly BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.5cd9043e-daf2-43eb-9568-54775fc4f84a2024-05-15WarningsExact identifier
unii: F5UM2KM3W7
Lymph IIIECHINACEA (ANGUSTIFOLIA), BOLDO, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, THYROIDINUM (SUIS), GERMANIUM SESQUIOXIDE, ARNICA MONTANA, CALCAREA IODATA, HAMAMELIS VIRGINIANA, HEPAR SULPHURIS CALCAREUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, UBIDECARENONUM, NAJA TRIPUDIANS, CALCAREA PHOSPHORICA, INFLUENZINUM (2022-2023), NATRUM SULPHURICUM, PYROGENIUM, SULPHUR, CARCINOSINBioActive Nutritional, Inc.c96d0e7e-35af-4597-b01a-dd3c908526b62024-05-13WarningsExact identifier
unii: 0YPR65R21J
DexamethasoneDEXAMETHASONEZydus Lifesciences Limitede9012a11-6219-4272-aea2-b7328bbcf5232024-05-13Exact identifier
unii: 7S5I7G3JQL
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, GERMANIUM METALLICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.4510fe59-cc28-4585-925f-42508a60abd02024-05-13WarningsExact identifier
unii: 451W47IQ8X
DexamethasoneDEXAMETHASONEViona Pharmaceuticals Inc360d3af0-8f69-4e82-ab5f-1f70cc2025d42024-05-13Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Inverness Ear CareBENZALKONIUM CHLORIDEThe Richline Group, Inc.180a2995-334c-2e93-e063-6294a90aecf72024-05-09WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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