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 116 of 132 · 2,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BABY MUCUS PLUS COLD RELIEFBRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDEHyland's Inc.d934cc8a-1e43-4942-858a-05b5d068679a2023-08-22WarningsExact identifier
unii: 451W47IQ8X
Acidum SulphuricumACIDUM SULPHURICUMHahnemann Laboratories, INC.038c2235-b113-963d-e063-6394a90a2b102023-08-22Exact identifier
unii: O40UQP6WCF
Fem Flora DefenseBAPTISIA TINCTORIA, BORAX, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, CINCHONA OFFICINALIS, ECHINACEA (ANGUSTIFOLIA), NITRICUM ACIDUM, PULSATILLA (PRATENSIS), PYROGENIUM, SEPIA, SULPHURICUM ACIDUM, THUJA OCCIDENTALISLiddell Laboratories, Inc.8015e1cb-9ebd-4b3e-af57-92f2754fb7902023-08-17WarningsExact identifier
unii: O40UQP6WCF
Hepaticol SarcodeCARDUUS MARIANUS, ZINGIBER OFFICINALE, BERBERIS VULGARIS, CHELIDONIUM MAJUS, MAGNESIA MURIATICA, LEPTANDRA VIRGINICA, NATRUM MURIATICUM, BRYONIA (ALBA), HEPAR (BOVINE), NATRUM SULPHURICUM, ATROPINUM SULPHURICUM, LYCOPODIUM CLAVATUMNutritional Specialties, Inc.f9d95b2f-53d9-4017-873f-5ad0b129f9f82023-08-14WarningsExact identifier
unii: 0YPR65R21J
unii: 451W47IQ8X
BreathtoneLOBELIA INFLATA, VERBASCUM THAPSUS, BALSAMUM PERUVIANUM, ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, DROSERA (ROTUNDIFOLIA), KALI BICHROMICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHOROUS, SPONGIA TOSTAEnergique, Inc.c388da29-824a-41a5-be85-47a60bccf3da2023-08-14WarningsExact identifier
unii: 0YPR65R21J
Liver Gallbladder HPBELLADONNA, CARDUUS MARIANUS, CHELIDONIUM MAJUS, COLOCYNTHIS, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), VERATRUM ALBUMEnergique, Inc.2746b098-50ce-472f-a4c1-87ca659852b92023-08-07WarningsExact identifier
unii: 0YPR65R21J
CellergyCALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SILICEA.Ratis, LLC2aebc11e-eeb7-436b-b90c-3a2f59fb74922023-08-07WarningsExact identifier
unii: 0YPR65R21J
unii: 451W47IQ8X
AndrotoxECHINACEA (ANGUSTIFOLIA), HYDROCOTYLE ASIATICA, SABAL SERRULATA, TABEBUIA IMPETIGINOSA, THUJA OCCIDENTALIS, ASTRAGALUS MEMBRANACEUS, GLANDULA SUPRARENALIS SUIS, LYMPH NODE (SUIS), ZINCUM GLUCONICUM, JUNIPERUS VIRGINIANA, MERCURIUS SOLUBILIS, NATRUM SULPHURICUM, ORCHITINUM (SUIS), PROSTATE (SUIS), PULSATILLA (PRATENSIS), RHODODENDRON CHRYSANTHUM, SPONGIA TOSTA, CALCAREA SULPHURICA, LYCOPODIUM CLAVATUM, PHOSPHORUS, BOTULINUM, ESCHERICHIA COLI, PROTEUS (VULGARIS), PSEUDOMONAS AERUGINOSA, SALMONELLA TYPHINOSODEBioActive Nutritional, Inc.d3f89e4d-c3a0-4481-bf0e-0413993a8bc52023-08-03WarningsExact identifier
unii: 0YPR65R21J
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.017f3bcf-0e45-d390-e063-6394a90a588e2023-07-28WarningsExact 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.017f0210-195d-11d7-e063-6294a90aa7502023-07-27WarningsExact identifier
unii: 451W47IQ8X
Natrum sulphuricumSODIUM SULFATEBoiron86567ee8-7a69-0cfe-e053-2a91aa0aa9c22023-07-20Exact identifier
unii: 0YPR65R21J
Natrum sulphuricumSODIUM SULFATEBoiron8656aa47-6d71-39a1-e053-2991aa0ac0122023-07-20Exact identifier
unii: 0YPR65R21J
Melatonin ProCALCAREA CARBONICA, CHAMOMILLA, COCCULUS INDICUS, COFFEA CRUDA, FERRUM PHOSPHORICUM, KALI PHOSPHORICUM, MAGNESIA CARBONICA, MELATONIN, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (PRATENSIS)Energique, Inc.1f374642-83f7-4e64-b330-0f6ef21000a92023-07-19WarningsExact identifier
unii: 451W47IQ8X
Gum TherapyCALENDULA OFFICINALIS, KALI PHOSPHORICUM, NATRUM MURIATICUM, ARNICA MONTANA, AGAVE AMERICANA, CISTUS CANADENSIS, KREOSOTUM, MYRRHA, CALCAREA FLUORICA, ACONITUM NAPELLUS, BISMUTHUM SUBNITRICUM, SEPIA, HEPAR SULPHURIS CALCAREUM, MERCURIUS VIVUSDeseret Biologicals0cf8a815-808d-4018-baf9-2b4545fc7ea82023-07-19WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLCb6e33138-841a-471f-a934-c4086cbc23f62023-07-17Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
AnpituaparHYPOPHYSIS SUIS, AGNUS CASTUS, BARYTA CARBONICA, CALCAREA CARBONICA, IODIUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, SEPIA, THYROIDINUM (SUIS), LAC CANINUM, ADRENOCORTICOTROPHINEnergique, Inc.c0ed2996-8eb5-43f7-b3cc-17477af7f7e92023-07-13WarningsExact identifier
unii: 451W47IQ8X
PneumotoxTRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM,BioActive Nutritional, Inc.f8846fb1-92e5-4f8e-b3b3-bc620df90a622023-07-12WarningsExact identifier
unii: 451W47IQ8X
ThyrostatFUCUS VESICULOSUS, SPONGIA TOSTA, HYPOPHYSIS SUIS, THYROIDINUM (SUIS), ARSENICUM IODATUM, BARYTA CARBONICA, IODIUM, LYCOPUS VIRGINICUS, NATRUM MURIATICUMEnergique, Inc.5c41b36c-e28f-4d60-b9b9-6b888d55ea952023-07-12WarningsExact identifier
unii: 451W47IQ8X
Natrum sulphuricumSODIUM SULFATEBoiron86480272-9593-2185-e053-2991aa0a3dd42023-07-11Exact identifier
unii: 0YPR65R21J
Introvert FormulaPASSIFLORA INCARNATA, PULSATILLA (PRATENSIS), IGNATIA AMARA, NATRUM MURIATICUM, DUODENUM (SUIS), PETROLEUM, SULPHURNutritional Specialties, Inc.522148c9-0bc0-44c9-8876-70051224c9512023-07-11WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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