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 129 of 132 · 2,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isolyte SSODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEB. Braun Medical Inc.7e8fe27f-ff82-48c1-9bf6-3c589c8e985d2020-05-14Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DEXTROSE AND SODIUM CHLORIDEDEXTROSE MONOHYDRATE, SODIUM CHLORIDEFresenius Kabi USA, LLCb825c9c4-f2fb-4a4a-9d8c-fb020ad07e932020-04-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirsta2b8220f-e33a-51c3-e053-2995a90a07342020-04-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirsta2bba76a-08ce-6902-e053-2995a90ab9c92020-04-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
TaperDex 6-dayDEXAMETHASONEProficient Rx LPa0d298f3-6ba6-45a5-81bf-82a3ad93d0a92020-03-01Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEBryant Ranch Prepack89e570c9-3e64-433b-9779-b94332f2b5ef2020-02-25Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Dextrose and Electrolyte No. 48SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, MONOBASIC POTASSIUM PHOSPHATE, SODIUM CHLORIDE AND DEXTROSE MONOHYDRATEBaxter Healthcare Companyb283a454-0c20-4fbf-92d3-dae1f3cd3cad2020-02-13Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporationfbc01464-8885-4075-af41-911ffec5ae922020-01-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ESSENTIAL WEIGHT LOSSAMMONIUM BROMATUM, FUCUS VESICULOSUS, NATRUM SULPHURICUM, NICOTINAMIDUM, SPONGIA TOSTA, THIAMINUM HYDROCHLORICUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THYROIDINUM (BOVINE), CALCAREA CARBONICA, GRAPHITESIntegrative Health Alliance4f114242-fbe0-4f23-bbe7-c74fa2d091aa2019-11-11WarningsExact identifier
unii: 0YPR65R21J
TobramycinTOBRAMYCINProficient Rx LP4eb4dfd1-f3ae-4400-b043-910b4c77296b2019-11-01Warnings, Adverse reactionsExact identifier
unii: VZ8RRZ51VK
TobramycinTOBRAMYCINProficient Rx LPac497300-eb1e-4021-b504-89f19e1eb0f32019-11-01Warnings, Adverse reactionsExact identifier
unii: VZ8RRZ51VK
Kids ReliefARSENICUM ALBUM, KALI PHOSPHORICUM, MERCURIS SOLUBILIS, NATRUM SULPHURICUM, HEPAR SULPHURIS CALCAREUM, ARUM TRIPHYLLUMHomeolab International (Canada) inc18a6f6d4-cdfd-4bf7-8cb2-831033c1d9652019-10-23WarningsExact identifier
unii: 0YPR65R21J
TaperDex 12-dayDEXAMETHASONEProficient Rx LPd66e36d3-f6f8-4fa8-84fb-7717463e37b32019-10-01Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Plasma-Lyte ASODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDEBaxter Healthcare Corporation6ec9e61c-2c26-402f-8604-f446b2e340582019-08-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
CPAP Mask cleaning wipesBENZETHONIUM CHLORIDE AND BENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.412e6fec-5af5-45f7-8c6b-393b884e161c2019-06-07WarningsExact identifier
unii: F5UM2KM3W7
BZK ToweletteBENZALKONIUM CHLORIDEAcme United Corporation866fdc1e-19b2-4d79-e053-2a91aa0a36fe2019-04-16WarningsExact identifier
unii: F5UM2KM3W7
Callington Anti-Bacterial Hand SanitiserBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.1c6650c9-29fa-4fba-8442-fe294a2087c02019-02-25WarningsExact identifier
unii: F5UM2KM3W7
Potassium Chloride in Dextrose and Sodium ChloridePOTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDEBaxter Healthcare Companyc553fed1-3de5-4826-8eff-633b5923bf0b2019-02-21Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Sodium ChloridePOTASSIUM CHLORIDE AND SODIUM CHLORIDEBaxter Healthcare Companybecc7410-0a25-49f5-b0c3-240078479dc82019-01-11Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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