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 15 of 132 · 2,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEBryant Ranch Prepack1884ef6f-a60c-4a82-a7dc-fd48b7176db02026-05-28Warnings, Adverse reactionsExact identifier
rxcui: 309683
unii: VZ8RRZ51VK
unii: 7S5I7G3JQL
PlegisolPOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDEHospira, Inc.35a174f0-f0d7-4ec7-3f81-d3d572c059cf2026-05-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Crayola ANTIBACTERIAL HAND WIPESBENZALKONIUM CHLORIDEASHTEL STUDIOS INC.49fc687b-cff1-02f1-e063-6394a90a04d02026-05-27WarningsExact identifier
unii: F5UM2KM3W7
BM BM213CARBO VEG, GRAPHITES, NAT PHOS, NAT SULPH, RHUS TOXBM Private Limited52cca143-b5cd-e1d9-e063-6394a90a5b152026-05-27WarningsExact identifier
unii: 0YPR65R21J
Antibacterial Lidocaine Wound GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDECVS Pharmacy960bfe55-87f6-3e51-e053-2995a90a867d2026-05-27WarningsExact identifier
unii: F5UM2KM3W7
MyMedic Antiseptic ToweletteBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd52b3ffec-8fe7-be9b-e063-6294a90a06922026-05-26WarningsExact identifier
unii: F5UM2KM3W7
TPN ElectrolytesSODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, AND SODIUM ACETATE ANHYDROUSHospira, Inc.c00817bc-7b62-4abe-0280-e7930eda3f942026-05-25Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
ACTIVE WIPESBENZALKONIUM CHLORIDEHangzhou Yida Technology Co., Ltd.52b0f451-343d-9d4d-e063-6294a90ad5e22026-05-25WarningsExact identifier
unii: F5UM2KM3W7
tazza Alcohol-Free sanitizerBENZALKONIUM CHLORIDETazza Brands East Inc.52642367-431e-ed1a-e063-6294a90a7fbf2026-05-22WarningsExact identifier
unii: F5UM2KM3W7
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SALINE CLEANINGSODIUM CHLORIDEGuangzhou Huanmei Cosmetics Co., Ltd.524f07cc-ddb9-dda5-e063-6394a90ac0a52026-05-21WarningsExact identifier
unii: 451W47IQ8X
GLOBAL CARE GOLD ANTIBACTERIAL HANDBENZALKONIUM CHLORIDEGLOBAL IMPORT SALES LLC30d4fa59-3b4c-a7fc-e063-6294a90aed052026-05-21WarningsExact identifier
unii: F5UM2KM3W7
Giant EagleBENZALKONIUM CHLORIDEGIANT EAGLEd2cbdd6c-79c3-0726-e053-2a95a90a46512026-05-20WarningsExact identifier
unii: F5UM2KM3W7
Benzalkonium ChlorideLIQUID HAND SOAPAMAZON.COM SERVICES LLC1bf99b68-c8a7-d88c-e063-6294a90ad2d22026-05-20WarningsExact identifier
unii: F5UM2KM3W7
HandsoapBENZALKONIUM CHLORIDECVS Pharmacy Inc.e582bdcf-0d8b-39f1-e053-2995a90a01f22026-05-20WarningsExact identifier
unii: F5UM2KM3W7
Hyvee LHSBENZALKONIUM CHLORIDEApollo Health and Beauty Care42f58da5-9b8b-a0f4-e063-6294a90a77d72026-05-20WarningsExact identifier
unii: F5UM2KM3W7
Giant EagleBENZALKONIUM CHLORIDEGIANT EAGLEd2cbfc4e-d118-5202-e053-2995a90aac6c2026-05-20WarningsExact identifier
unii: F5UM2KM3W7
Hyvee LHSBENZALKONIUM CHLORIDEApollo Health and Beauty Care423f5f82-8521-65aa-e063-6294a90a11802026-05-20WarningsExact identifier
unii: F5UM2KM3W7
LIDLBENZALKONIUM CHLORIDELIDL US LLCca13681e-4cdd-30c7-e053-2a95a90ad05a2026-05-20WarningsExact identifier
unii: F5UM2KM3W7
WINCO CITRUS LHSBENZALKONIUM CHLORIDEWINCO FOODS, LLC261d768c-8ec7-4b16-e063-6294a90a23a02026-05-20WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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