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 70 of 132 · 2,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MEDI-FIRST First Aid AntisepticBENZALKONIUM CHLORIDEUltra Distributors Incb6efaca5-49d0-b000-e053-2995a90ab9aa2025-04-07WarningsExact identifier
unii: F5UM2KM3W7
Walgreens Max Strength Burn GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEWalgreens Co.25a1e89b-bafd-4770-e063-6294a90a14d22025-04-07WarningsExact identifier
unii: F5UM2KM3W7
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONESandoz Inc05fd0c36-39b4-4a43-8490-eb8dfc0920ae2025-04-07Warnings, Adverse reactionsExact identifier
application number: NDA050592
ndc (product): 61314-647
rxcui: 309683
unii: VZ8RRZ51VK
unii: 7S5I7G3JQL
EcolabBENZALKONIUM CHLORIDEEcolab Inc.f646187a-6f78-436c-a397-7541a2c691b82025-04-04WarningsExact identifier
unii: F5UM2KM3W7
Bestmade Natural Products Nat Mur 8xNATRUM MURIATICUMBestmade Natural Products31e0e16d-e4df-cd9a-e063-6394a90abcc12025-04-03WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Nat Sulph 8xNATRUM SULPHURICUMBestmade Natural Products31e12d31-d2a6-06a6-e063-6394a90abe412025-04-03WarningsExact identifier
unii: 0YPR65R21J
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
Respiforce AARNICA MONTANA, ASCLEPIAS TUBEROSA, ERIODICTYON CALIFORNICUM, EUCALYPTUS GLOBULUS, LOBELIA INFLATA, PLANTAGO MAJOR, TRIFOLIUM PRATENSE, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CARBO VEGETABILIS, GRINDELIA, KALI CARBONICUM, NATRUM SULPHURICUM, PULSATILLA,BioActive Nutritionale9360698-bffb-4c91-b019-22e1e56704ee2025-04-02WarningsExact identifier
unii: 0YPR65R21J
Kidneyforce-HPARNICA MONTANA, AURUM METALLICUM, CACTUS GRANDIFLORUS, CALCAREA CARBONICA, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, SOLIDAGO VIRGAUREABioActive Nutritional, Inc.0c0f0c0c-10c2-47eb-aad6-bbffb6e167992025-04-02WarningsExact identifier
unii: 451W47IQ8X
Nurture ANTISEPTIC WIPESBENZALKONIUM CHLORIDEDevon Products, LLCff2c761f-1a82-467b-9a5f-a2cdbd2be9352025-04-02WarningsExact identifier
unii: F5UM2KM3W7
Tobradex STTOBRAMYCIN / DEXAMETHASONEHarrow Eye, LLC3b99dbb3-ac84-4d0d-b30f-a5db44fdc3162025-04-01Warnings, Adverse reactionsExact identifier
unii: VZ8RRZ51VK
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEProficient Rx LP3f2fe98a-ab42-4bec-bf97-c090567f9ad62025-04-01Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Meijer Antibacterial Foaming Hand Wash0.13% BENZALKONIUM CHLORIDE SOLUTIONMeijer, Inc.1eb6b603-ef96-dfda-e063-6294a90ae4682025-03-31WarningsExact identifier
unii: F5UM2KM3W7
WhiskCare 387BENZALKONIUM CHLORIDEWhisk Products, Inc.35bb7d59-111e-fa47-e063-6394a90aaf1e2025-03-31WarningsExact identifier
unii: F5UM2KM3W7
MeijerBENZALKONIUM CHLORIDEMeijer1e69a1b6-1b2b-8db7-e063-6294a90a78e92025-03-28WarningsExact identifier
unii: F5UM2KM3W7
ANTIBACTERIAL BANDAGESBENZALKONIUM CHLORIDEGuangdong Comfort Medical Products Co., Ltd.da241df2-6153-05e4-e053-2a95a90a09842025-03-26WarningsExact identifier
unii: F5UM2KM3W7
ZoviroBENZALKONIUM CHLORIDEZoviro, LLC0b41ff48-a0da-2bc6-e063-6294a90a7e982025-03-26WarningsExact identifier
unii: F5UM2KM3W7
ZoviroBENZALKONIUM CHLORIDEZoviro, LLC0b567ef2-a782-3daa-e063-6294a90a064e2025-03-26WarningsExact identifier
unii: F5UM2KM3W7
Forticept HP Antiseptic Wound CleanserBENZALKONIUM CHLORIDE, ALLANTOINLidan, inc.41bb46ee-edce-4e1b-bcfd-5c5729e1eb152025-03-25WarningsExact identifier
unii: F5UM2KM3W7
Sodium ChlorideSODIUM CHLORIDE TABLETBelleview Bioscience LLC31195e8f-d4de-9e37-e063-6294a90a41562025-03-24WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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