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 71 of 132 · 2,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bestmade Natural Products BIO13 Lactose FreeCALC PHOS KALI SULPH, KALI PHOS, NAT MURBestmade Natural Products303590c5-8a66-aafc-e063-6294a90a1a4e2025-03-23WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO13CALC PHOS, KALI SULPH, KALI PHOS, NAT MURBestmade Natural Products2fffab7f-0d4b-0e96-e063-6294a90a34d82025-03-23WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Nat MurNAT MURBestmade Natural Productse9e9a4f6-5104-3c6f-e053-2995a90a11652025-03-21WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Nat SulphNAT SULPHBestmade Natural Productse9ea2ea5-d1f2-6678-e053-2a95a90a278f2025-03-21WarningsExact identifier
unii: 0YPR65R21J
Klean-Them Hand Sanitizing TowelsBENZALKONIUM CHLORIDERite-Kem, Inc.30dedeee-aadd-6436-e063-6394a90a0cde2025-03-21WarningsExact identifier
unii: F5UM2KM3W7
Pituitary LiquescenceCAULOPHYLLUM THALICTROIDES, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, PINEAL GLAND (SUIS), CIMICIFUGA RACEMOSA, NATRUM MURIATICUM, CINCHONA OFFICINALIS, ADRENOCORTICOTROPHINNutritional Specialties, Inc.292ca967-abe8-4ae1-b2fe-942531a1e14a2025-03-20WarningsExact identifier
unii: 451W47IQ8X
Anxiety HPACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, CALCAREA CARBONICA, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), STAPHYSAGRIA, STRAMONIUMEnergique, Inc.191393fa-5f36-43c0-a183-09258eef9bda2025-03-20WarningsExact identifier
unii: 451W47IQ8X
XTRA Squeeze Antibacterial Hand Juicy OrangeBENZALKONIUM CHLORIDEMY IMPORTS USA LLC304ab556-36d8-5fba-e063-6394a90a234a2025-03-19WarningsExact identifier
unii: F5UM2KM3W7
XTRA Squeeze Antibacterial Hand Juicy OrangeBENZALKONIUM CHLORIDEZhejiang Jifu Daily Chemical Co., Ltd.2f03b094-c470-d0f4-e063-6394a90a47fc2025-03-19WarningsExact identifier
unii: F5UM2KM3W7
HYDRA NEBSODIUM CHLORIDEVenture Healthcare Ltd30b184bf-2451-d96b-e063-6294a90a43c72025-03-19WarningsExact identifier
unii: 451W47IQ8X
HYDRA NEBSODIUM CHLORIDELaboratoire Unither30b244c0-84bb-a0a0-e063-6394a90a9dee2025-03-19WarningsExact identifier
unii: 451W47IQ8X
DEBACHERE Butt Balm After Play Care Multi Symptoms ReliefBENZOCAINE, BENZALKONIUM CHLORIDEDE.BACHERE USA LLCf469b446-58a0-4be3-884f-d622b9d074f82025-03-17WarningsExact identifier
unii: F5UM2KM3W7
Bestmade Natural Products Restful Legs SupportCALCAREA PHOSPHORICA, ACONITE NAP, ANACARDIUM ORI, ARGENTUM NIT, ARSENIC ALB, AURUM MUR, CHAMOMILLA, DUBOISIA, GELSEMIUM, IGNATIA, KALI BROM, LACHESIS MUTUS, LYCOPODIUM, MAG MUR, MOSCHUS, NAT CARB, NAT SULPH, PHOSPHORIC ACID, RAUWOLFIA SERPBestmade Natural Products304b48ac-c4b8-a5c0-e063-6394a90a07b62025-03-14WarningsExact identifier
unii: 0YPR65R21J
Bestmade Natural Products BIO16 Lactose FreeCALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MURBestmade Natural Products3036922b-0f2c-12ff-e063-6394a90a85782025-03-13WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO19 Lactose FreeFERR PHOS, MAG PHOS, KALI SULPH, NAT SULPHBestmade Natural Products3038b39b-839d-417f-e063-6294a90ac4c02025-03-13WarningsExact identifier
unii: 0YPR65R21J
Bestmade Natural Products BIO20 Lactose FreeCALC FLUOR, CALC SULPH, KALI SULPH, NAT MUR, NAT SULPHBestmade Natural Products30394e7e-170f-7b9d-e063-6394a90afcdb2025-03-13WarningsExact identifier
unii: 0YPR65R21J
unii: 451W47IQ8X
Bestmade Natural Products BIO25 Lactose FreeNAT PHOS, NAT SULPH, SILICEABestmade Natural Products303acd47-e033-1563-e063-6394a90ae38e2025-03-13WarningsExact identifier
unii: 0YPR65R21J
Bestmade Natural Products BIO27 Lactose FreeNAT MUR, KALI PHOS, CALC PHOSBestmade Natural Products303b25cc-b559-3841-e063-6294a90a398b2025-03-13WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO28 Lactose FreeCALC FLUOR, CALC PHOS, CALC SULPH, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEABestmade Natural Products303b4d92-9f75-38a5-e063-6294a90ae93d2025-03-13WarningsExact identifier
unii: 0YPR65R21J
unii: 451W47IQ8X
Psora MiasmEGGSHELL MEMBRANE, WHEY PROTEIN, CALCAREA CARBONICA, LYCOPODIUM CLAVATUM, SULPHUR, ARSENICUM ALBUM, CROTON TIGLIUM, GRAPHITES, HYDROCOTYLE ASIATICA, NATRUM MURIATICUMEnergique, Inc.6a12aa49-35fc-41f4-bec8-6f9a20a97caa2025-03-13WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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