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 75 of 132 · 2,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TobramycinTOBRAMYCINBelcher Pharmaceuticals, LLC17b5b083-79ab-46b5-bed6-866e5415c6232025-02-11Warnings, Adverse reactionsExact identifier
unii: VZ8RRZ51VK
12 CELL SALTS COMPLEXCALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SILICEASEVENE USAff0f69cd-97a2-7183-e053-6394a90ad0392025-02-10WarningsExact identifier
unii: 0YPR65R21J
unii: 451W47IQ8X
Stress-TensionCHAMOMILLA, HYPERICUM PERFORATUM, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, ARGENTUM NITRICUM, AURUM METALLICUM, BAPTISIA, BRYONIA, CHELIDONIUM MAJUS, CIMICIFUGA RACEMOSA, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, LILIUM TIGRINUM, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PICRICUM ACIDUM, PLUMBUM METALLICUM, SEPIA, STAPHYSAGRIA, STRAMONIUM, THUJA OCCIDENTALIS, ZINCUM METALLICUM.Newton Laboratories, Inc.9d22bedb-9f9d-8421-e053-2a95a90acf4a2025-02-10WarningsExact identifier
unii: 451W47IQ8X
Swimmers FriendANTIMONIUM TART., ARNICA MONTANA, BELLIS PERENNIS, BRYONIA, CALCAREA CARBONICA, CAPSICUM ANNUUM, CHELIDONIUM MAJUS, CUPRUM METALLICUM, DIGITALIS PURPUREA, DROSERA, LACHESIS MUTUS, LACTICUM ACIDUM, LEDUM PALUSTRE, MAGNESIA CARBONICA, MANGANUM ACETICUM, NUX VOMICA, PHYTOLACCA DECANDRA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SARCOLACTICUM ACIDUM, SULPHURICUM ACIDUM, VERBASCUM THAPSUS, VIPERA BERUSNewton Laboratories, Inc.9d260197-0c81-0df2-e053-2a95a90a44102025-02-10WarningsExact identifier
unii: O40UQP6WCF
Stress-TensionCHAMOMILLA, HYPERICUM PERFORATUM, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, ARGENTUM NITRICUM, AURUM METALLICUM, BAPTISIA, BRYONIA, CHELIDONIUM MAJUS, CIMICIFUGA RACEMOSA, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, LILIUM TIGRINUM, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PICRICUM ACIDUM, PLUMBUM METALLICUM, SEPIA, STAPHYSAGRIA, STRAMONIUM, THUJA OCCIDENTALIS, ZINCUM METALLICUM.Newton Laboratories, Inc.9d23e5da-4806-8ccc-e053-2995a90a19012025-02-10WarningsExact identifier
unii: 451W47IQ8X
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: 451W47IQ8X
DexamethasoneDEXAMETHASONEPreferred Pharmaceuticals Inc.b883860c-27ba-4bac-8ae3-4cf4d82d50712025-02-10Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Bestmade Natural Products BM115BORAX, CAPSICUM, CONDURANGO, HYDRASTIS MUR, KALI PERMANGANATUM, MERC SOL, NITRIC ACID, SULPHURIC ACIDBestmade Natural Products2d901bf9-b71d-06b5-e063-6294a90a5e4a2025-02-07WarningsExact identifier
unii: O40UQP6WCF
Bestmade Natural Products BM118ANACARDIUM ORI, ARSENIC ALB, AURUM MUR, KALI BROM, LYCOPODIUM, NATRUM CARB, NATRUM SULPH, PHOSPHORIC ACIDBestmade Natural Products2d90b08b-b65d-7d11-e063-6294a90a50922025-02-07WarningsExact identifier
unii: 0YPR65R21J
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
IncontinenceALOE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BENZOICUM ACIDUM, BRYONIA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM, IGNATIA, KALI PHOS., LYCOPODIUM, NAT. MUR., NITRICUM AC., PLANTAGO, PULSATILLA, RHUS AROMATICA , SABAL, SECALE, SEPIA, STAPHYSAG.,STRAMONIUM, THYROIDINUM, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.9c0cd92b-905d-f90f-e053-2995a90a47052025-02-07WarningsExact identifier
unii: 451W47IQ8X
IncontinenceALOE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BENZOICUM ACIDUM, BRYONIA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM, IGNATIA, KALI PHOS., LYCOPODIUM, NAT. MUR., NITRICUM AC., PLANTAGO, PULSATILLA, RHUS AROMATICA , SABAL, SECALE, SEPIA, STAPHYSAG.,STRAMONIUM, THYROIDINUM, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.9c0d8c82-6c4f-a511-e053-2995a90a793f2025-02-07WarningsExact identifier
unii: 451W47IQ8X
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONENuCare Pharmaceuticals,Inc.b7b39ad5-e158-b8fe-e053-2995a90a52792025-02-07Warnings, Adverse reactionsExact identifier
rxcui: 309683
unii: VZ8RRZ51VK
unii: 7S5I7G3JQL
Appetite - Craving ControlANACARDIUM ORIENTALE, ANTIMON.CRUD., ARG. NIT., BERBER. VULG., BRYONIA, CHELIDONIUM MAJUS, DIGITALIS, GRAPHITES, HUMULUS,IRIS VERSICOLOR, KALI CARB., LYCOPODIUM, NAT. CARB.,NAT. SULPHURICUM, NUX VOM., PULSATILLA, RHUS. TOXICODENDRON, SCUTELLARIA LATERIFLORA, SEPIA,STRAMONIUM, CHAMOMILLA, PASSIFLORA, VALERIANA.Newton Laboratories, Inc.7964f0f7-7774-fac6-e053-2a91aa0a3e4a2025-02-06WarningsExact identifier
unii: 0YPR65R21J
Appetite - Craving ControlANACARDIUM ORIENTALE, ANTIMON.CRUD., ARG. NIT., BERBER. VULG., BRYONIA, CHELIDONIUM MAJUS, DIGITALIS, GRAPHITES, HUMULUS,IRIS VERSICOLOR, KALI CARB., LYCOPODIUM, NAT. CARB.,NAT. SULPHURICUM, NUX VOM., PULSATILLA, RHUS. TOXICODENDRON, SCUTELLARIA LATERIFLORA, SEPIA,STRAMONIUM, CHAMOMILLA, PASSIFLORA, VALERIANA.Newton Laboratories, Inc.79655acc-f059-e509-e053-2a91aa0ac4882025-02-06WarningsExact identifier
unii: 0YPR65R21J
Dairy-Grain-NightshadesIRIS VERS., SOLIDAGO, ANTIMON. CRUD., ARG. NIT., ARSENICUM ALB., AVENA, BAPTISIA, BELLADONNA, BRYONIA, CAPSICUM, CARDUUS BEN., CINCHONA, DULCAMARA, FAGOPYRUM, GELSEMIUM, HYOSCYAMUS, IPECAC., LAC VAC., LACHESIS, LYCOPODIUM, NAT. MUR., PHOS., PODOPH. PELT., PULSATILLA, RHUS TOX., SAC. LAC., SECALE, SEPIA, STRAMONIUM, TABACUM, TRITICUM, USTILAGO MAIDIS, VERBASCUM, LYCOPERSICUM, SOLANUM NIG., SOLANUM TUB., STIGMATA, TORULA CEREVISIAE.Newton Laboratories, Inc.9ba83c60-35be-181a-e053-2a95a90a98952025-02-06WarningsExact identifier
unii: 451W47IQ8X
4 Kids Cold and Cough NighttimeONION, CALCIUM SULFIDE, SODIUM CHLORIDE, ANEMONE PULSATILLA, ARABICA COFFEE BEAN, MATRICARIA CHAMOMILLA, SULFUR, PHOSPHORUS AND GOLDENSEALHyland's Consumer Health Inc.71e93027-33c9-6147-e053-2a95a90aaa092025-02-06WarningsExact identifier
unii: 451W47IQ8X
BIOPURE 50CT ANTI BACTERIAL HAND WIPESBENZALKONIUM CHLORIDEZhejiang Furuisen Spunlaced Nonwovens Co., Ltd.ecef31dc-2f36-b578-e053-2995a90a3acd2025-02-05WarningsExact identifier
unii: F5UM2KM3W7
Lavex Alcohol Free Foaming Instant Hand SanitizerBENZALKONIUM CHLORIDEClark Core Services, LLC2d6b0760-52ad-9073-e063-6394a90ab0602025-02-05WarningsExact identifier
unii: F5UM2KM3W7
Lavex Foaming Antibacterial HandBENZALKONIUM CHLORIDEClark Core Services, LLC2d7d57dc-c3af-0fa8-e063-6394a90a00a02025-02-05WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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