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 101 of 132 · 2,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Helzberg Diamonds Ear CareBENZALKONIUM CHLORIDEThe Richline Group, Inc.180a3776-0edd-26f3-e063-6294a90a740d2024-05-09WarningsExact identifier
unii: F5UM2KM3W7
Ulta Beauty Ear CareBENZALKONIUM CHLORIDEThe Richline Group, Inc.180a37f4-8718-3e40-e063-6294a90acaad2024-05-09WarningsExact identifier
unii: F5UM2KM3W7
DexamethasoneDEXAMETHASONENuCare Pharmaceuticals,Inc.17f56402-331e-2e3d-e063-6394a90acc0e2024-05-08Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.47a0313f-36df-4fa6-a828-c9e1946ba9b02024-05-08Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDEFresenius Kabi USA, LLCf0cc6713-4d47-49be-8116-901c99002b6b2024-05-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.7f22c06b-6b4d-4b49-a4b2-d2169f2bd6532024-05-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEAsclemed USA, Inc.f4ca52c6-9f90-7bb5-e053-2a95a90ae3ff2024-05-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDEFresenius Kabi USA, LLC97001218-086c-430a-9e0d-6c7031c91d942024-05-06Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDEFresenius Kabi USA, LLCfe5b5182-c859-4c74-b2e0-467be5b2e3292024-05-06Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.f2475fa3-ab1d-4b81-8127-b58cd0790a542024-05-06Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Tork Hand Sanitizer Alcohol Free FoamBENZALKONIUM CHLORIDEEssity Professional Hygiene North America LLCd2e6d469-ddcc-4cad-829f-245dc1ec83682024-05-02WarningsExact identifier
unii: F5UM2KM3W7
Tork Foam AntibacterialBENZALKONIUM CHLORIDEEssity Professional Hygiene North America LLC45416b88-3703-4934-9439-9f23233427442024-05-02WarningsExact identifier
unii: F5UM2KM3W7
enMotion Antimicrobial Foam with Moisturizers Tranquil AloeBENZALKONIUM CHLORIDEGeorgia-Pacific Consumer Productsfe0bded7-a268-db59-e053-6294a90aee442024-05-02WarningsExact identifier
unii: F5UM2KM3W7
GP enMotion Antimicrobial FoamBENZALKONIUM CHLORIDEGeorgia-Pacific Consumer Productsc846eb52-3db4-1a74-e053-2a95a90aa84d2024-05-02WarningsExact identifier
unii: F5UM2KM3W7
Pacific Blue ultra Antimicrobial Foam Fragrance FreeBENZALKONIUM CHLORIDEGeorgia-Pacific Consumer Productsfe165a79-6947-eb25-e053-6294a90a98f52024-05-02WarningsExact identifier
unii: F5UM2KM3W7
GP PBU Antimicrobial FoamBENZALKONIUM CHLORIDEGeorgia Pacific Consumer Productsc8d09207-d152-5abc-e053-2a95a90aaf922024-05-02WarningsExact identifier
unii: F5UM2KM3W7
enMotion Antimicrobial Foam with Moisturizers Fragrance FreeBENZALKONIUM CHLORIDEGeorgia-Pacific Consumer Productsfdb5776b-7d6c-84f9-e053-6394a90a0c392024-05-02WarningsExact identifier
unii: F5UM2KM3W7
Pacific Blue ultra Antimicrobial Foam Pacific CitrusBENZALKONIUM CHLORIDEGeorgia-Pacific Consumer Productsfe1727b4-b016-74fc-e053-6394a90ad78a2024-05-02WarningsExact identifier
unii: F5UM2KM3W7
Weed Grass AntigensALLIUM CEPA, ARSENICUM ALBUM, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (PRATENSIS), ABROTANUM (ARTEMISIA ABROTANUM), ABSINTHIUM, AGRIMONIA EUPATORIA, FLOS, ALFALFA, AMBROSIA ARTEMISIAEFOLIA, ARUNDO MAURITANICA, BAMBUSA ARUNDINACEA, CICHORIUM INTYBUS, FLOS, KENTUCKY BLUEGRASS, ORCHARD GRASS, BERMUDA GRASS, JOHNSON GRASS, RYE GRASS, VERNAL GRASS, BAHIA GRASS, TIMOTHY GRASS, RUMEX CRISPUS, SABADILLA, SINAPIS ARVENSIS, FLOS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, TRIFOLIUM REPENS,Energique, Inc.8a28f56a-6010-42e3-b360-e6e22b86222a2024-05-02WarningsExact identifier
unii: 451W47IQ8X
CliniClean BZK Cleansing SwabsticksBENZALKONIUM CHLORIDEHR HealthCaree4978038-58ee-4ca3-b05f-d5ecab102fa92024-04-30WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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