FDA.reportPublic FDA data

NDC 55150-403-01 - Gentamicin

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
55150-403
Requested NDC
55150-403-01
Package NDCs from labels
55150-403-01, 55150-403-25
Manufacturer
Eugia US LLC | EUGIA PHARMA SPECIALITIES LIMITED
Effective date
2026-01-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Gentamicin - Eugia US LLC | EUGIA PHARMA SPECIALITIES LIMITEDEugia US LLC | EUGIA PHARMA SPECIALITIES LIMITED2026-01-29Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-403-01Gentamicin20 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION202
55150-403-25Gentamicin25 in 1 CARTONINJECTION, SOLUTION252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-403GENTAMICIN INJECTION, SOLUTION [EUGIA US LLC]1Current NDC, 2 package rows20240110_60ca1487-392d-4721-aa45-3de38722896c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-403-01ML - Milliliter55150-40339e64311-bc42-4327-a103-036bf511dcf212024-04-05
55150-403-25ML - Milliliter55150-4038a8c94ae-5116-493d-b1d3-39c669d26cd712024-04-05

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 10 of 14 · 274 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eye WashWATERJiangxi Zhenmei Biological Technology Co.,Ltdc68795b8-bf68-0d01-e053-2a95a90abebb2023-12-04WarningsExact identifier
unii: 059QF0KO0R
MYCCombinationALLIUM CEPA, ECHINACEA (ECHINACEA ANGUSTIFOLIA), NATRUM SULPHURICUM, KALI CARBONICUM, MEPHITIS MEPHITICA, SANGUINARIA CANADENSIS, BLATTA ORIENTALIS, AGARICUS MUSCARIUS, ANTIMONIUM TARTARICUM, ARSENICUM IODATUM, CARBOLICUM ACIDUM, CINCHONA OFFICINALIS, FERRUM METALLICUM, PHYTOLACCA DECANDRA, SECALE CORNUTUM, SULPHURICUM ACIDUM, THUJA OCCIDENTALIS, AMMONIUM CARBONICUM, ASPERGILLUS NIGERDeseret Biologicals, Inc.795c34c6-71c8-4c36-b441-4bca55a435752023-12-04WarningsExact identifier
unii: O40UQP6WCF
Gentamicin SulfateGENTAMICIN SULFATECosette Pharmaceuticals, Inc.16474069-510b-0754-9d78-9bc0354f65492023-11-23Adverse reactionsExact identifier
unii: 8X7386QRLV
Gentamicin SulfateGENTAMICIN SULFATECosette Pharmaceuticals, Inc.9e550dc9-509e-da05-8a97-ecbd0f5dd6332023-11-22Adverse reactionsExact identifier
unii: 8X7386QRLV
Sulphuricum acidumSULFURIC ACIDBoiron8692f851-0484-fa7d-e053-2991aa0a8e572023-11-15Exact identifier
unii: O40UQP6WCF
Sulphuricum acidumSULFURIC ACIDBoiron8692a44d-2f50-d574-e053-2991aa0a7ee62023-11-15Exact identifier
unii: O40UQP6WCF
Sulphuricum acidumSULFURIC ACIDBoiron87713f93-9bd2-2fbf-e053-2995a90aaf9e2023-11-15Exact identifier
unii: O40UQP6WCF
Sulphuricum acidumSULFURIC ACIDBoiron86922572-6e29-fff4-e053-2991aa0abbd02023-11-15Exact identifier
unii: O40UQP6WCF
GentamicinGENTAMICIN SULFATEMedical Purchasing Solutions, LLC09cf88af-59da-f147-e063-6294a90aac992023-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313996
unii: 8X7386QRLV
GentamicinGENTAMICIN SULFATEFresenius Kabi USA, LLC0cce2238-28d3-4280-b520-ffc3067a2ffa2023-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313996
unii: 8X7386QRLV
PollutoxSULPHURICUM ACIDUM, BERBERIS VULGARIS, ARSENICUM ALBUM, BENZINUM, CADMIUM SULPHURATUM, HYDROFLUORICUM ACIDUM, MELATONIN, NITROGENUM OXYGENATUM, NUX VOMICA, PETROLEUM, PLUMBUM METALLICUM, STANNUM METALLICUM, TOLUENE, ACETONE, CARBON DIOXIDE, CHLORINUM, MERCURIUS SOLUBILIS, URANIUM NITRICUM, OZONEDeseret Biologicals, Inc.14a1f0a6-1b22-449c-b4dd-f8feb72155542023-10-26WarningsExact identifier
unii: O40UQP6WCF
GentamicinGENTAMICINFresenius Kabi USA, LLCbe5b414e-d598-4721-80ee-5836156ad2102023-10-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 8X7386QRLV
GentamicinGENTAMICIN SULFATEFresenius Kabi USA, LLCa73a5453-c091-43fd-aae2-d992152363b12023-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313996
unii: 8X7386QRLV
Enviro Detox FormulaLAPPA MAJOR, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, SPINACIA, PETROLEUM, PLUMBUM METALLICUM, SULPHURICUM ACIDUM, AMMONIUM PHOSPHORICUM, ARSENICUM ALBUM, CHROMIUM (METALLICUM), CUPRUM METALLICUM, DIBROMOETHANE, KREOSOTUM, MERCURIUS VIVUS, MTBE (TERT-BUTYL METHYL ETHER), NITRICUM ACIDUM, RADIUM BROMATUMNutritional Specialties, Inc.83825312-dff8-4caa-8afa-bb1eab7397f72023-10-06WarningsExact identifier
unii: O40UQP6WCF
GentamicinGENTAMICINHikma Pharmaceuticals USA Inc.51fffac8-fb6e-4f7f-b2de-440252781a422023-09-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313996
unii: 8X7386QRLV
ANUBISMEDHA HYALURONICANUBIS COSMETICS SLeac771e2-4c1b-3808-e053-2995a90ac5fc2023-09-05WarningsExact identifier
unii: 059QF0KO0R
AnubisMedSPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSIONANUBIS COSMETICS SLe99d92c4-8768-9c0a-e053-2a95a90a609e2023-09-05WarningsExact identifier
unii: 059QF0KO0R
AnubisMedAZELAIC ACID, SALICYLIC ACIDANUBIS COSMETICS SLebf3153d-30f5-54e4-e053-2995a90a74b12023-09-05WarningsExact identifier
unii: 059QF0KO0R
AnubisMedGLYCOLIC ACID, CITRIC ACID, LACTIC ACID, KOJIC ACIDANUBIS COSMETICS SLeca95dde-cb57-2ab6-e053-2995a90af84f2023-09-05WarningsExact identifier
unii: 059QF0KO0R
AnubisMedSODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREAANUBIS COSMETICS SLebf4b3ab-34e1-185a-e053-2a95a90ace3a2023-09-05WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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