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 98 of 132 · 2,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph/Spleen ComboADENOSINUM TRIPHOSPHORICUM DINATRUM, APIS MELLIFICA, CASTANEA VESCA, CEANOTHUS AMERICANUS, CHININUM ARSENICOSUM, FERRUM METALLICUM, HELIANTHUS ANNUUS, JUNIPERUS COMMUNIS, LYMPH NODE (SUIS), MYOSOTIS ARVENSIS, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, QUERCUS GLANDIUM SPIRITUS, SPLEEN (SUIS), SUCCINUM, THYMUS (SUIS), UBIDECARENONUMDeseret Biologicals, Inc.afce86e2-cbfa-44d4-b803-bc2ad50533572024-07-31WarningsExact identifier
unii: 0YPR65R21J
unii: 451W47IQ8X
Lymph/Spleen ComboJUNIPERUS COMMUNIS, QUERCUS GLANDIUM SPIRITUS, MYOSOTIS ARVENSIS, NATRUM SULPHURICUM, CEANOTHUS AMERICANUS, HELIANTHUS ANNUUS, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, LYMPH NODE (SUIS), SPLEEN (SUIS), THYMUS (SUIS), CHININUM ARSENICOSUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, UBIDECARENONUM, FERRUM METALLICUM, SUCCINUM, CASTANEA VESCA, APIS MELLIFICADeseret Biologicals, Inc.b55787b5-5e35-4342-8f00-ef202c3538772024-07-31WarningsExact identifier
unii: 0YPR65R21J
unii: 451W47IQ8X
EcolabBENZALKONIUM CHLORIDEEcolab Inc.70516b96-5394-4f67-92c4-c50601c259462024-07-30WarningsExact identifier
unii: F5UM2KM3W7
KeystoneBENZALKONIUM CHLORIDEEcolab Inc.6860a80e-9a5f-40e4-bec3-e7386e541f5b2024-07-30WarningsExact identifier
unii: F5UM2KM3W7
AdrenaparARALIA QUINQUEFOLIA, AVENA SATIVA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS SUIS, ARSENICUM IODATUM, CALCAREA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ZINCUM METALLICUMEnergique, Inc.4080fcfb-7ef2-45f5-8c3b-592d3b66a1202024-07-29WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporationf55bd888-5e01-474d-871b-24654c0701782024-07-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Breath HPAMMONIUM MURIATICUM, ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BRYONIA (ALBA), CALCAREA CARBONICA, LOBELIA INFLATA, NATRUM SULPHURICUM, PHOSPHORUS, SPONGIA TOSTAEnergique, Inc.f487452a-e3de-4cd1-bda7-90b6b4daf9712024-07-23WarningsExact identifier
unii: 0YPR65R21J
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLC83994d0c-8484-4505-abb5-8a384ed122882024-07-22Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
sodium chlorideSODIUM CHLORIDEBecton Dickinson and Company8df7dcf6-8714-6caf-e053-2995a90ab8cc2024-07-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Ecolab Inc.BENZALKONIUM CHLORIDEEcolab Inc.de3b8c33-0d6c-49a9-8243-0d52284770f42024-07-12WarningsExact identifier
unii: F5UM2KM3W7
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
Ecolab Inc.BENZALKONIUM CHLORIDEEcolab Inc.7345c155-b5f2-4d29-b469-1153e103cc892024-07-12WarningsExact identifier
unii: F5UM2KM3W7
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONENuCare Pharmaceuticals,Inc.54da7bef-c3b0-4353-e054-00144ff8d46c2024-07-10Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Novex Anti-Bacterial Hand Sanitizer WipeBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.7832a0be-a8ce-4b56-a9bb-a375b97df2872024-07-10WarningsExact identifier
unii: F5UM2KM3W7
Callington Anti-Bacterial Hand Sanitizer WipeBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.00ca48ca-893d-4a3f-ad90-119522664e082024-07-10WarningsExact identifier
unii: F5UM2KM3W7
Ecolab Inc.BENZALKONIUM CHLORIDEEcolab Inc.388ca447-2267-419f-acec-17b808b27a5a2024-07-10WarningsExact identifier
unii: F5UM2KM3W7
Pure ForceBENZALKONIUM CHLORIDEEcolab Inc.66fd73be-05c8-4905-96f5-f73fa1447b3f2024-07-09WarningsExact identifier
unii: F5UM2KM3W7
Sani Luxe Foaming Hand Sanitizer Alcohol FreeBENZALKONIUM CHLORIDECeleste Industries Corporation7549428e-b10f-45b9-b414-0c6e8b41c3982024-07-08WarningsExact identifier
unii: F5UM2KM3W7
DexamethasoneDEXAMETHASONEProficient Rx LP45fd8030-dbe3-4da4-9d0a-6549cf4f73592024-07-01Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Genuine First Aid Antiseptic ToweletteBENZALKONIUM CHLORIDEGFA Production (Xiamen) Co., Ltd.dfff78d2-e23c-40b2-8a49-8f4140bb0df62024-06-25WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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