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 83 of 132 · 2,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NativeRemedies Triple Complex Mood TonicKALI PHOS, NAT PHOS, NAT SULPH.Silver Star Brandsf782db2a-d2af-a12d-e053-6294a90a16b72025-01-01WarningsExact identifier
unii: 0YPR65R21J
Total Solutions Alcohol-Free Hand Sanitizing WipesBENZALKONIUMAthea Laboratories, Inc.2ce0d8ad-2734-33df-e063-6394a90ab7282025-01-01WarningsExact identifier
unii: F5UM2KM3W7
Total Solutions Alcohol-Free Hand Sanitizing FoamBENZALKONIUMAthea Laboratories, Inc.2f37a2a1-5252-4052-e063-6294a90aef7f2025-01-01WarningsExact identifier
unii: F5UM2KM3W7
DG Health Sterile Saline MistSODIUM CHLORIDEDG Healthf2e44ab4-ae0f-c87b-e053-2a95a90acd042024-12-31WarningsExact identifier
unii: 451W47IQ8X
Hawthorn Hygiene Solutions ENERGY ANTIBACTERIAL FOAM FRAGRANCE FREE 1200 mLBENZALKONIUM CHLORIDEBUNZL Distribution7fefd5c4-0bbf-4c25-a269-1440ae90e3dc2024-12-31WarningsExact identifier
unii: F5UM2KM3W7
Reliable Brand Powered by PURELL Antimicrobial Scented Foam CB10 1.2LBENZALKONIUM CHLORIDEVeritiv Operating Company61121dcd-adc0-41a6-82f4-c1902571cb7a2024-12-31WarningsExact identifier
unii: F5UM2KM3W7
PURELL Antimicrobial Foaming HandBENZALKONIUM CHLORIDEGOJO Industries, Inc.fd5d9942-1cd3-4c40-84bf-beb4327682192024-12-31WarningsExact identifier
unii: F5UM2KM3W7
Reliable Brand Powered by PURELL Antimicrobial Fragrance Free Foam CB10 1.2LBENZALKONIUM CHLORIDEVeritiv Operating Company3d96d8da-a820-4776-ae7d-5d0ca730dd302024-12-31WarningsExact identifier
unii: F5UM2KM3W7
PURELL Antimicrobial Fragrance Free Foaming Hand SPBENZALKONIUM CHLORIDEGOJO Industries, Inc.4477d823-3658-43ac-bb51-fd20888606c92024-12-31WarningsExact identifier
unii: F5UM2KM3W7
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONEAdvanced Rx of Tennessee, LLC09315f0b-f15a-30d5-e063-6394a90ac8dd2024-12-31Warnings, Adverse reactionsExact identifier
application number: NDA050592
ndc (package): 80425-0366-1
ndc (product): 80425-0366
ndc11 (package): 80425036601
rxcui: 309683
spl id: 2a998d83-7bae-3f5e-e063-6294a90acd3d
spl set id: 09315f0b-f15a-30d5-e063-6394a90ac8dd
unii: VZ8RRZ51VK
unii: 7S5I7G3JQL
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONENEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONEAdvanced Rx Pharmacy of Tennessee, LLCf1a05d5f-74f2-17a1-e053-2995a90ab0e72024-12-31Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Tobramycin and dexamethasoneTOBRAMYCIN AND DEXAMETHASONEAdvanced Rx Pharmacy of Tennessee, LLCf4c00d9c-3a17-06a0-e053-2a95a90a84132024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 309683
unii: VZ8RRZ51VK
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEAdvanced Rx Pharmacy of Tennessee, LLCfa16db27-3c8c-eb22-e053-6394a90add592024-12-31Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Citrus Fresh Liquid AntimicrobialBENZALKONIUM CHLORIDEHillyard GMP8abcace0-08b7-45ea-8f4f-cc74417db58a2024-12-31WarningsExact identifier
unii: F5UM2KM3W7
Citrus Fresh Foaming AntimicrobialBENZALKONIUM CHLORIDEHillyard GMP086b7f58-59f3-429e-a2d8-8a5ffed0f8202024-12-31WarningsExact identifier
unii: F5UM2KM3W7
Hillyard Alcohol Free Foaming Instant Hand SanitizerBENZALKONIUM CHLORIDEHillyard GMPa066bd4e-8f1d-4dfe-8754-fc7fd5ae48f92024-12-30WarningsExact identifier
unii: F5UM2KM3W7
KEEPAN ABENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.a30679d5-5507-499d-9d9f-498095fd32ac2024-12-30WarningsExact identifier
unii: F5UM2KM3W7
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONENuCare Pharmaceuticals,Inc.a7e55c43-4345-4710-e053-2995a90aeee72024-12-30Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Total Solutions Hygien HandBENZALKONIUMAthea Laboratories, Inc.fcd63fe4-a357-4432-a738-ae1bccbb8bae2024-12-30WarningsExact identifier
unii: F5UM2KM3W7
Hillyard E2 Food Industry FoamingBENZALKONIUM CHLORIDEHillyard GMP81148442-6ee2-4655-85e4-27c2753c5c272024-12-30WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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