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 99 of 132 · 2,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antibacterial FoamSoapBENZALKONIUM CHLORIDEFerguson Enterprises18f9c948-74aa-ae19-e063-6294a90a23a12024-06-24WarningsExact identifier
unii: F5UM2KM3W7
TobramycinTOBRAMYCINNorthStar RxLLC634efd82-1a35-40cf-9893-50c27d6610832024-06-24Warnings, Adverse reactionsExact identifier
unii: VZ8RRZ51VK
Sodium ChlorideSODIUM CHLORIDECODAN US CORPORATIONaa06e286-75c6-4d7a-959f-6008d38aa6e52024-06-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Nuvik Large Roll in Bucket Antibacterial Hand WipesBENZALKONIUM CHLORIDENuvik Usa, Inc.1f2035a1-0b8a-435e-a5ef-6ceda863fd372024-06-18WarningsExact identifier
unii: F5UM2KM3W7
AntimicrobialBODY CLEANSERMcKesson8ff06cea-3427-5b40-e053-2995a90a06342024-06-17WarningsExact identifier
unii: F5UM2KM3W7
Tobramycin Ophthalmic SolutionTOBRAMYCIN OPHTHALMIC SOLUTIONAlembic Pharmaceuticals Limited14c14f81-6b0a-4176-a5df-d0757cc3260d2024-06-14Warnings, Adverse reactionsExact identifier
unii: VZ8RRZ51VK
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
Tobramycin Ophthalmic SolutionTOBRAMYCIN OPHTHALMIC SOLUTIONAlembic Pharmaceuticals Inc.3c23234a-452b-40d0-922f-37e49147d5372024-06-14Warnings, Adverse reactionsExact identifier
unii: VZ8RRZ51VK
Derma Pain PlusCROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOXICODENDRON, SARSAPARILLA (SMILAX REGELII)Peaceful Mountain, Inc.6fa79c31-e48e-4c83-baa2-96cef22cfee12024-06-13WarningsExact identifier
unii: 451W47IQ8X
Cold Sore RescueBORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEAPeaceful Mountain, Inc.a7fe6ec7-a758-43cf-b46f-c327e0632fb82024-06-13WarningsExact identifier
unii: 451W47IQ8X
Three CleansingBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltd1ab25c0d-e616-30f7-e063-6294a90ad1e42024-06-12WarningsExact identifier
unii: F5UM2KM3W7
DexamethasoneDEXAMETHASONEBryant Ranch Prepack710ce0fc-78b3-402d-a2ca-e5eda09f32112024-06-11Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONEA-S Medication Solutions6791e6c3-514d-4b98-8887-ca2b894576b52024-06-10Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Neomycin Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONENuCare Pharmaceuticals,Inc.691bc5ca-5d61-60c2-e053-2991aa0abb932024-06-07Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONENuCare Pharmaceuticals,Inc.61693e79-81d1-3162-e053-2a91aa0ae9252024-06-06Warnings, Adverse reactionsExact identifier
rxcui: 309683
unii: VZ8RRZ51VK
unii: 7S5I7G3JQL
Antiseptic WipeBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltd1a3c5fc9-70cc-e857-e063-6294a90a34242024-06-06WarningsExact identifier
unii: F5UM2KM3W7
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
NATRUM MURNATRUM MURRxhomeo Private Limited d.b.a. Rxhomeo, Inc1a22655a-68f3-4f13-e063-6294a90ae52c2024-06-05WarningsExact identifier
unii: 451W47IQ8X
NATRUM SULPHNATRUM SULPHRxhomeo Private Limited d.b.a. Rxhomeo, Inc1a229b91-7cc7-3442-e063-6394a90a66922024-06-05WarningsExact identifier
unii: 0YPR65R21J
FIRST AID BURNLIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDEEpic Medical Supply Corpbd1b1873-e900-45eb-96a0-28f782b5a7cd2024-06-04WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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