FDA.reportPublic FDA data

NDC 80425-0341-01 - Tobramycin

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
80425-0341
Requested NDC
80425-0341-01
Package NDCs from labels
80425-0341-1, 80425-0341-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tobramycin - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0341-1Tobramycin1 in 1 CARTONSOLUTION12
80425-0341-1Tobramycin5 mL in 1 BOTTLE, DROPPERSOLUTION52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0341TOBRAMYCIN SOLUTION [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 2 package rows20241207_fc734c2d-0d45-195c-e053-6394a90a2a92.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0341-1ML - Milliliter80425-03410f56ac19-bc08-4c51-b8fe-64cff333c22c12023-07-06

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 8 of 69 · 1,370 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDESportpharm LLCa2c111f6-74d5-4a5d-82ac-d0f237488cb82026-04-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEMethod Pharmaceuticals, LLC4b08859e-65bd-8255-e063-6394a90af6142026-04-23WarningsExact identifier
unii: 451W47IQ8X
RingersSODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEICU Medical, Inc.a926f913-18fa-4a3e-bfd6-210e1e4279602026-04-20Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
LIVER TONIC ICARDUUS MARIANUS, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, CHIONANTHUS VIRGINICA, QUASSIA (AMARA), HEPAR BOVINE, CEANOTHUS AMERICANUS COLOCYNTHIS, LEPTANDRA VIRGINICA, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, TEUCRIUM MARUMBioActive Nutritional, Inc.aed2d198-ec53-479c-8bd8-38f57504632a2026-04-17WarningsExact identifier
unii: 0YPR65R21J
Cardioforce IIABROTANUM, BOLDO, CIMICIFUGA RACEMOSA, KALI PHOSPHORICUM, TARAXACUM OFFICINALE, CONVALLARIA MAJALIS, MAGNESIA SULPHURICA, OLEANDER, NATRUM MURIATICUM, BELLIS PERENNISBioActive Nutritional, Inc.733bbb26-7698-4a1b-9dc8-7e3490ffc92b2026-04-17WarningsExact identifier
unii: 451W47IQ8X
LGB HPBELLADONNA, CHELIDONIUM MAJUS, COLOCYNTHIS, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (VULGARIS), VERATRUM ALBUMBioActive Nutritional, Inc.4f6db767-4c5d-4f86-894d-99ff6db7c9202026-04-17WarningsExact identifier
unii: 0YPR65R21J
Thyroid HPBARYTA CARBONICA, CALCAREA CARBONICA, FUCUS VESICULOSUS, IODIUM, NATRUM MURIATICUM, PULSATILLA, SPONGIA TOSTA, THYROIDINUM (SUIS)BioActive Nutritional, Inc.3795820a-cf2a-4094-9a02-70e3757b75102026-04-17WarningsExact identifier
unii: 451W47IQ8X
Pneumo HPAMMONIUM MURIATICUM, ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, CALCAREA CARBONICA, LOBELIA INFLATA, NATRUM SULPHURICUM, SPONGIA TOSTA, PHOSPHORUS,BioActive Nutritional, Inc.532dd216-746c-4a56-98b4-cf90e2e509ac2026-04-17WarningsExact identifier
unii: 0YPR65R21J
HepataforceCARDUUS MARIANUS, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, NATRUM SULPHURICUMBioActive Nutritional9ffe2336-6a38-405d-a6fd-cf39670039ff2026-04-17WarningsExact identifier
unii: 0YPR65R21J
DIANEAL Low Calcium with DextroseSODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCaa268d3f-7389-4f25-801f-5d4825495f082026-04-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEWilshire Pharmaceuticals, Inc.b251752d-7750-482a-9364-0acf4ad47cc82026-04-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLC99c6a1a9-cadf-435b-a332-ccc189afdfa92026-04-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
TOBI PodhalerTOBRAMYCINViatris Specialty LLCc4b5bb1f-e158-4ac1-9c35-e98a416c743a2026-04-15Warnings, Adverse reactionsExact identifier
unii: VZ8RRZ51VK
IntestiparGENTIANA LUTEA, ARSENICUM ALBUM, BERBERINUM, CINCHONA OFFICINALIS, COLOCYNTHIS, HYDRASTIS CANADENSIS, INDOLUM, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, SMALL INTESTINE (SUIS)Energique, Inc.28bd4306-800c-4d98-9b1f-1af37b0dc1122026-04-15WarningsExact identifier
unii: 0YPR65R21J
GoLYTELYPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEAzurity Pharmaceuticals, Inc.7609ecf7-0ce0-4fbb-9c27-30987f6895752026-04-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
TRILYTEPOLYETHYLENE GLYOCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDEAurobindo Pharma Limited79f5e596-8d51-4227-afcc-f5e3411509572026-04-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Anxiety ReliefACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, AURUM METALLICUM, GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, IGNATIA AMARA, KALI CARBONICUM, MOSCHUS, NATRUM MURIATICUM, PIPER METHYSTICUMNaturalCare9f982e89-655c-49be-85d8-4099a02ed0212026-04-15WarningsExact identifier
unii: 451W47IQ8X
PEG 3350, sodium chloride, sodium bicarbonate and potassium chloridePOLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDEWilshire Pharmaceuticals, Inc.4e442a72-b13b-4869-8a1d-59356095b0912026-04-14Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDE 1 GRAMSODIUM CHLORIDEGendose Pharmaceuticals, LLCce988ae5-61c6-4324-90e1-a94c8a54d0d02026-04-13WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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