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 113 of 132 · 2,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hygiene Clean Pumpkin Spice Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCb568ab0a-1108-9f0c-e053-2a95a90ab0ce2023-10-28WarningsExact identifier
unii: F5UM2KM3W7
X3 Clean Foaming Hand SanitizerBENZALKONIUM CHLORIDEHK Kolmar Canada, Inc3c636145-03fe-47c7-81fc-279fef69b1c32023-10-27WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Lilac Garden Hand Sanitizer Bottle Alcohol FreeBENZALKONIUM CHLORIDEUSA Broom LLCba70ed1c-83db-5eaa-e053-2a95a90a92cc2023-10-27WarningsExact identifier
unii: F5UM2KM3W7
Pine and Honey Scent FOAMING HAND SANITIZERBENZALKONIUM CHLORIDEK7 DESIGN GROUP INC95b0c8b2-901b-40f8-ae75-732c3821ee472023-10-26WarningsExact identifier
unii: F5UM2KM3W7
Vanilla Coconut Scent FOAMING HAND SANITIZERBENZALKONIUM CHLORIDEK7 DESIGN GROUP INC1932ccc6-6b8c-4dc4-bf74-1a155b596f3b2023-10-26WarningsExact identifier
unii: F5UM2KM3W7
Mountain Air Scent FOAMING HAND SANITIZERBENZALKONIUM CHLORIDEK7 DESIGN GROUP INCc80fc58e-e2a5-4c8e-a211-abe81fc1231d2023-10-26WarningsExact identifier
unii: F5UM2KM3W7
Simply Lavender Scent FOAMING HAND SANITIZERBENZALKONIUM CHLORIDEK7 DESIGN GROUP INC8a75bcab-5a4b-4e3b-a838-2f2ce0224b8d2023-10-26WarningsExact identifier
unii: F5UM2KM3W7
PollutoxSULPHURICUM ACIDUM, BERBERIS VULGARIS, ARSENICUM ALBUM, BENZINUM, CADMIUM SULPHURATUM, HYDROFLUORICUM ACIDUM, MELATONIN, NITROGENUM OXYGENATUM, NUX VOMICA, PETROLEUM, PLUMBUM METALLICUM, STANNUM METALLICUM, TOLUENE, ACETONE, CARBON DIOXIDE, CHLORINUM, MERCURIUS SOLUBILIS, URANIUM NITRICUM, OZONEDeseret Biologicals, Inc.14a1f0a6-1b22-449c-b4dd-f8feb72155542023-10-26WarningsExact identifier
unii: O40UQP6WCF
SalineNASALGERI-CARE PHARMACEUTICAL CORPd293cc13-4043-0d58-e053-2995a90a3fbc2023-10-24WarningsExact identifier
unii: 451W47IQ8X
g and h Protect HandBENZALKONIUM CHLORIDEAccess Business Group LLC1103a4af-10d6-478f-85cd-c364569569e52023-10-23WarningsExact identifier
unii: F5UM2KM3W7
BZKBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltdd96c6ad2-c7e9-4079-9db2-59d108f284bb2023-10-23WarningsExact identifier
unii: F5UM2KM3W7
Obstetrical ToweletteBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltd8db4eb14-85b6-4c8e-9623-39a43b3827a12023-10-23WarningsExact identifier
unii: F5UM2KM3W7
WIPE OUT Antibacterial Wipes, Lemon ScentBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltdafd72ac9-d6e8-75ec-e053-2a95a90a141d2023-10-23WarningsExact identifier
unii: F5UM2KM3W7
WIPE OUT Antibacterial Wipes, Fresh ScentBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltdafd76301-e165-7098-e053-2995a90a29262023-10-23WarningsExact identifier
unii: F5UM2KM3W7
BZK Antiseptic Towelette SterileBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltdf787ff2f-0cdf-46ee-b401-603e34a767702023-10-23WarningsExact identifier
unii: F5UM2KM3W7
BZK Antiseptic Towelette Non-SterileBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltd481dd61c-7691-44dc-83b4-c1ee6898c3be2023-10-23WarningsExact identifier
unii: F5UM2KM3W7
Cleansing ToweletteBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltd13c23da8-51d7-480c-b8ae-5bf91043d0a32023-10-23WarningsExact identifier
unii: F5UM2KM3W7
Antiseptic BZK ToweletteBENZALKONIUM CHLORIDECardinal Health 200, Inc.8dd79ffe-f742-438c-9814-612f900ad6a92023-10-23WarningsExact identifier
unii: F5UM2KM3W7
Hand Sanitizing WipesBENZALKONIUM CHLORIDEEz Products Of South Florida, LLC89dab85e-4888-442a-b8a1-4f23d356f5952023-10-23WarningsExact identifier
unii: F5UM2KM3W7
New Wave Cleaning Solutions Foaming Hand SanitizerBENZALKONIUM CHLORIDENEW WAVE CLEANING SOLUTIONS,LLCb79b2f50-4d87-5b75-e053-2995a90a40d42023-10-23WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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