FDA.reportPublic FDA data

NDC 80425-0260-01 - 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
80425-0260
Requested NDC
80425-0260-01
Package NDCs from labels
80425-0260-1, 80425-0260-01
Manufacturer
Advanced Rx Pharmacy 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 Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0260-1Tobramycin and dexamethasone5 mL in 1 BOTTLE, PLASTICSUSPENSION/ DROPS52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0260TOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 1 package rows20250102_f4c00d9c-3a17-06a0-e053-2a95a90a8413.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0260-1ML - Milliliter80425-026033bbad4d-1036-4f44-8e5c-d87c2d9c4ebc12023-04-07

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 2 of 11 · 206 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
application number: ANDA212715
rxcui: 309683
unii: VZ8RRZ51VK
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONECardinal Health 107, LLCbf8acfdb-8dc8-4a69-90b0-33c680c421d62026-05-15Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
dexamethasoneDEXAMETHASONECardinal Health 107, LLC5622f8d2-1893-441b-8011-fa90c8a63b0b2026-05-05Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONESportpharm LLC12d19271-867b-41ae-a6d2-7e8de36370112026-04-24Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEPangea Pharmaceuticals, LLC37607468-0331-44c0-9bb4-5c614c7b69d42026-04-19Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Ciprofloxacin and dexamethasoneCIPROFLOXACIN AND DEXAMETHASONESentiss Pharmaceuticals LLC355fa56f-d7a8-444e-9dec-8ba1fa4ab0d82026-04-16Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
TOBI PodhalerTOBRAMYCINViatris Specialty LLCc4b5bb1f-e158-4ac1-9c35-e98a416c743a2026-04-15Warnings, Adverse reactionsExact identifier
unii: VZ8RRZ51VK
Ciprofloxacin and dexamethasoneCIPROFLOXACIN AND DEXAMETHASONESun Pharmaceutical Industries, Inc.641bad60-9b9e-43ea-936e-5c38f27835b22026-04-02Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
dexamethasoneDEXAMETHASONEPreferred Pharmaceuticals Inc.4c619d48-8cf9-4085-8405-c8f066bce19c2026-04-01Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEPreferred Pharmaceuticals, Inc.c4d1e578-a1d2-4d5e-8426-6b2c39f0d9bd2026-04-01Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONENuCare Pharmaceuticals,Inc.c33e84ba-4c0c-f738-e053-2995a90aa20a2026-03-27Warnings, Adverse reactionsExact identifier
rxcui: 309683
unii: VZ8RRZ51VK
unii: 7S5I7G3JQL
dexamethasoneDEXAMETHASONEMajor Pharmaceuticals64b46398-9b97-45e8-b1ba-1a202d5744482026-03-26Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
TobramycinTOBRAMYCINSportpharm LLCe2aa8499-2eab-4ea2-b122-6c7b1ad0c35c2026-03-20Warnings, Adverse reactionsExact identifier
unii: VZ8RRZ51VK
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONESportpharm LLC7ed85675-bc46-4dd6-bb8f-7e98c3eb84e22026-03-20Warnings, Adverse reactionsExact identifier
rxcui: 309683
unii: VZ8RRZ51VK
unii: 7S5I7G3JQL
Ciprofloxacin and dexamethasoneCIPROFLOXACIN AND DEXAMETHASONENuCare Pharmaceutical, Inc.4d650d9d-a98a-2dbe-e063-6294a90a00772026-03-19Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
OZURDEXDEXAMETHASONEAllergan, Inc.4b204f44-6e8a-4d17-803c-268f0b04679f2026-03-11Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONEPreferred Pharmaceuticals Inc.8a143864-e36b-49bf-91b4-c6cc1a9280312026-02-26Warnings, Adverse reactionsExact identifier
rxcui: 309683
unii: VZ8RRZ51VK
unii: 7S5I7G3JQL
Ciprofloxacin and DexamethasoneCIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONEUpsher-Smith Laboratories, LLC9c5994d1-01d1-493c-a6ae-94754cd593892026-02-13Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DEXAMETHASONEDEXAMETHASONENuCare Pharmaceuticals, Inc.4a808dd5-35b7-e879-e063-6394a90a0bf72026-02-10Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
tobramycinTOBRAMYCINSlate Run Pharmaceuticals, LLCed254eec-10f4-425a-895b-66e325b7bf692026-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: VZ8RRZ51VK

Reported adverse events (FAERS/openFDA)#

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