FDA.reportPublic FDA data

NDC 55150-401-01 - 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
55150-401
Requested NDC
55150-401-01
Package NDCs from labels
55150-401-01, 55150-401-25
Manufacturer
Eugia US LLC | EUGIA PHARMA SPECIALITIES LIMITED
Effective date
2026-01-27
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 LIMITED2026-01-27Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-401-01Gentamicin2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION22
55150-401-25Gentamicin25 in 1 CARTONINJECTION, SOLUTION252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-401GENTAMICIN INJECTION, SOLUTION [EUGIA US LLC]1Current NDC, 2 package rows20240110_f8c608b3-50b8-4d5d-9e8a-e92c0d2e3cdc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-401-01ML - Milliliter55150-401614d970c-08b4-4fc8-aba9-125536b63ef112024-04-05
55150-401-25ML - Milliliter55150-401faf84610-6381-4d73-abdc-213b9d6971b112024-04-05

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 14 of 14 · 261 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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