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 128 of 132 · 2,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Feminine ComfortAGARICUS MUSC., ARSENICUM ALB., AUR. MET., BERBER. AQUI., CALADIUM SEGUINUM, CANDIDA ALBICANS, CANTHARIS, CONIUM, GRAPHITES, HELONIAS DIOICA, HYDRASTIS, KALI CARB., KREOSOTUM, LYCOPODIUM, MERC. VIV., MUREX PURPUREA, NAT. MUR., NITRICUM AC., PULSATILLA, RHUS TOXICODENDRON, SEPIA, SULPHUR, TARENTULA HISPANA, THUJA OCC., ZINC. MET., APIS MEL., HAMAMELISNewton Laboratories, Inc.9ab4520d-1dd3-7b9f-e053-2a95a90a274f2020-11-25WarningsExact identifier
unii: 451W47IQ8X
Blues - Mood - EmotionsANGELICA 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, GINKGONewton Laboratories, Inc.79890e75-dfac-0262-e053-2a91aa0a5ce52020-11-24WarningsExact identifier
unii: 451W47IQ8X
Blues - Mood - EmotionsANGELICA 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, GINKGONewton Laboratories, Inc.798ab5a2-7464-8e9d-e053-2a91aa0acc982020-11-24WarningsExact identifier
unii: 451W47IQ8X
Cold Hands - FeetHISTAMINUM 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, ECHINACEANewton Laboratories, Inc.7a2b4f28-2128-a8b2-e053-2a91aa0a24022020-11-24WarningsExact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEAsclemed USA, Inc.afac6cc5-1ced-4639-b6f6-86f40ef5c30e2020-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
TobramycinTOBRAMYCINAsclemed USA, Inc.5564e780-2320-4ce7-b211-806ca99110c32020-10-24Warnings, Adverse reactionsExact identifier
unii: VZ8RRZ51VK
GUNA ALLERGYADRENALINUM - 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 spaae6bd80d-2c70-1a3f-e053-2a95a90a26522020-10-23WarningsExact identifier
unii: 451W47IQ8X
GUNA MATRIX DETOXSODIUM SULFATE - PODOPHYLLUM PELTATUM ROOT - SOLIDAGO VIRGAUREA FLOWERING TOP - APIS MELLIFERA - EQUISETUM HYEMALE - STRYCHNOS NUX VOMICA SEED - HAMAMELIS VIRGINIANA ROOT BARK STEM BARK - LYCOPODIUM CLAVATUM SPORE - GALIUM APARINE WHOLE - THUJA OCCIDENTALIS LEAFY TWIG - BERBERIS VULGARIS ROOT BARK - MYOSOTIS ARVENSIS - CHELIDONIUM MAJUS WHOLE - FUCUS VESICULOSUS -Guna spaa369b95b-4d57-f149-e053-2995a90a87e32020-10-23Warnings, Adverse reactionsExact identifier
unii: 0YPR65R21J
GUNA ARTHRO RELIEFARTERIA SUIS - ALPHA KETOGLUTARICUM ACIDUM - ALPHA LIPOICUM ACIDUM - ASCORBICUM ACIDUM - BARIUM OXALSUCCINICUM - BRYONIA ALBA - CALCAREA CARBONICA - CARTILAGO SUIS - CHLORINUM - CIMICIFUGA RACEMOSA - COLCHICUM AUTUMNALE - DULCAMARA - EMBRYO SUIS - FUNICULUS UMBILICALIS SUIS - GLANDULA SUPRARENALIS SUIS - NADIDUM - NATRUM OXALACETICUM - NATRUM SULPHURICUM - PLACENTA TOTALIS SUIS - RHUS TOXICODENDRON - SULPHUR- VENA SUIS -Guna spaaebb990a-65bc-54ed-e053-2995a90a56822020-10-23WarningsExact identifier
unii: 0YPR65R21J
InterSolPLATELET ADDITIVE 3Fenwal, Inc.a00c4a93-cde2-4753-81f7-0d6fee9fb6902020-10-20Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Life is Simple Hand SanitizerNON-ALCOHOL FOAMING HAND SANITIZERApollo Health and Beauty Care0c5fad07-a91a-4d5f-8554-0d2f3a13ab132020-10-06WarningsExact identifier
unii: F5UM2KM3W7
GUNA DEEP CLEANSEAPIS MELLIFERA - BERBERIS VULGARIS ROOT BARK - CHELIDONIUM MAJUS - CHONDRODENDRON TOMENTOSUM ROOT - EQUISETUM HYEMALE WHOLE - FUCUS VESICULOSUS - GALIUM APARINE WHOLE - HAMAMELIS VIRGINIANA ROOT BARK - LYCOPODIUM CLAVATUM SPORE - MYOSOTIS ARVENSIS - PODOPHYLLUM PELTATUM ROOT - RANCID BEEF - SODIUM SULFATE - SOLIDAGO VIRGAUREA FLOWERING TOP - STRYCHNOS NUX VOMICA SEED - THUJA OCCIDENTALIS LEAFY TWIG -Guna spaaf5e3933-4b2f-0966-e053-2995a90aaf2c2020-09-24Warnings, Adverse reactionsExact identifier
unii: 0YPR65R21J
DexamethasoneDEXAMETHASONEBryant Ranch Prepacka9fd2013-0797-4ec4-82c5-07d2825226252020-09-17Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstac0fd44a-3f39-8d7e-e053-2995a90afeec2020-08-04Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
CardioplegicCALCIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM CHLORIDEBaxter Healthcare Corporation1fd50ce5-2799-4c26-81da-02cf0578dd9e2020-06-11Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirsta62b71db-8ba2-6f6b-e053-2a95a90a29d12020-05-21Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
LACTATED RINGERS AND DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATEHF Acquisition Co LLC, DBA HealthFirsta62cf623-9b8a-37e0-e053-2995a90add5b2020-05-21Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
BronCareECHINACEA, 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, INFLUENZINUMNewton Laboratories, Inc.a5281807-675f-07f7-e053-2995a90a3a8a2020-05-18WarningsExact identifier
unii: 0YPR65R21J
Hay FeverAPIS 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 SEMPERVIRENSNewton Laboratories, Inc.a6045b91-d361-2731-e053-2a95a90a97722020-05-18WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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