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 41 of 132 · 2,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MG FoamSanBENZALKONIUM CHLORIDEMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.c5311836-674a-400b-a0d3-92f959d926822025-12-29WarningsExact identifier
unii: F5UM2KM3W7
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
ANTIBACTERIAL LAVENDER BOUQUETBENZALKONIUM CHLORIDEUniversal Distribution Center LLC37dde4b1-872e-4079-9936-66f33b9320d92025-12-29WarningsExact identifier
unii: F5UM2KM3W7
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
Ciprofloxacin and dexamethasoneCIPROFLOXACIN AND DEXAMETHASONERedpharm Drug2fd20fcb-222c-bd38-e063-6294a90ac9cd2025-12-27Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONENorthwind Health Company, LLCaa30086a-8551-413e-9cf2-6393093cfcfd2025-12-26Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Zep FS Antimicrobial Hand CleanerBENZALKONIUM CHLORIDEZep Inc.a5ee28cb-edd6-0a58-e053-2a95a90a87892025-12-26WarningsExact identifier
unii: F5UM2KM3W7
Zep Fuzion Antimicrobial Hand CleanerBENZALKONIUM CHLORIDEZep Inc.a5ff51d4-2735-993b-e053-2a95a90a85952025-12-26WarningsExact identifier
unii: F5UM2KM3W7
Zep Antibacterial HSBENZALKONIUM CHLORIDEZep Inc.b43c3dea-b8f9-a384-e053-2995a90abe8c2025-12-26WarningsExact identifier
unii: F5UM2KM3W7
Zep FS Antimicrobial Foaming Hand CleanerBENZALKONIUM CHLORIDEZep Inc.b43e7d79-8de3-b151-e053-2a95a90afc7b2025-12-26WarningsExact identifier
unii: F5UM2KM3W7
Fuzion AB FoamBENZALKONIUM CHLORIDEZep Inc.b43ea64e-f7db-2250-e053-2995a90a43b32025-12-26WarningsExact identifier
unii: F5UM2KM3W7
Zep Mild AntibacterialBENZALKONIUM CHLORIDEZep Inc.b43c3030-2ef1-23a0-e053-2995a90a36a62025-12-26WarningsExact identifier
unii: F5UM2KM3W7
Zep Acclaim ABBENZALKONIUM CHLORIDEZep Inc.b43c0b5b-b476-fdc3-e053-2a95a90a70b32025-12-26WarningsExact identifier
unii: F5UM2KM3W7
Zep Blue Sky ABBENZALKONIUM CHLORIDEZep Inc.b4643941-bb50-a3bb-e053-2995a90a5c162025-12-26WarningsExact identifier
unii: F5UM2KM3W7
Zep Handstand AntimicrobialBENZALKONIUM CHLORIDEZep Inc.b4645d99-d956-3f67-e053-2995a90a82bf2025-12-26WarningsExact identifier
unii: F5UM2KM3W7
Zep Mango ABBENZALKONIUM CHLORIDEZep Inc.b43ffcbe-d47a-5883-e053-2a95a90acf9a2025-12-26WarningsExact identifier
unii: F5UM2KM3W7
Zep Acclaim ABBENZALKONIUM CHLORIDEZep Inc.b43bc291-bf12-fea6-e053-2a95a90aa74a2025-12-26WarningsExact identifier
unii: F5UM2KM3W7
Zep Professional Mild ABBENZALKONIUM CHLORIDEZep Inc.b43b2607-a546-5109-e053-2a95a90a889e2025-12-26WarningsExact identifier
unii: F5UM2KM3W7
Zep Fuzion FS Antimicrobial Foaming Hand CleanerBENZALKONIUM CHLORIDEZep Inc.b43e9dff-4260-26a5-e053-2995a90a85702025-12-26WarningsExact identifier
unii: F5UM2KM3W7
Zep Tranq Mdw AB FoamBENZALKONIUM CHLORIDEZep Inc.5c3c1ab7-96a7-6ca5-e053-2991aa0af2b92025-12-26WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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