FDA.reportPublic FDA data

NDC 0409-1207-15 - Gentamicin Sulfate

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
0409-1207
Requested NDC
0409-1207-15
Package NDCs from labels
0409-1207-13, 0409-1207-03, 0409-1207-15, 0409-1207-25
Manufacturer
Hospira, Inc.
Effective date
2026-05-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Gentamicin SulfateHospira, Inc.2026-05-20HUMAN PRESCRIPTION DRUG LABEL
Gentamicin Sulfate - Cardinal Health 107, LLCCardinal Health 107, LLC2026-05-08HUMAN PRESCRIPTION DRUG LABEL
Gentamicin Sulfate Injection, USP 80mg/2ml (40 mg/mL as Gentamicin)Henry Schein, Inc.2025-10-31HUMAN PRESCRIPTION DRUG LABEL
Gentamicin Sulfate - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2025-05-15HUMAN PRESCRIPTION DRUG LABEL
GENTAMICIN SULFATE - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2024-01-27HUMAN PRESCRIPTION DRUG LABEL
Gentamicin Sulfate - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2023-05-03HUMAN PRESCRIPTION DRUG LABEL
Gentamicin Sulfate - Hospira, Inc. | Lek d.d.Hospira, Inc. | Lek d.d.2022-11-17HUMAN PRESCRIPTION DRUG LABEL
Gentamicin Sulfate - General Injectables & Vaccines, IncGeneral Injectables & Vaccines, Inc2021-11-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-1207-03Gentamicin Sulfate25 in 1 TRAYINJECTION, SOLUTION2522
0409-1207-13Gentamicin Sulfate2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION222

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-1207GENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]21Current NDC, Legacy NDC, 2 package rows20241218_977180b3-a222-4282-d485-4a3217674305.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1207-03ML - Milliliter0409-1207b5d0f1ef-7c73-4fea-b4c9-9da361f7442412012-07-24
0409-1207-13ML - Milliliter0409-1207878db672-5c41-42ef-bba3-a1c57bc826c712018-02-20
0409-1207-15ML - Milliliter0409-12075582700a-cbe2-45e1-aec9-99f5c34a7dca12019-04-11
0409-1207-25ML - Milliliter0409-12073e0f5a91-ba57-48c1-9414-b94a3427b02d12016-03-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVGENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]13
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]13
EDETATE DISODIUM ANHYDROUSINACTIVE INGREDIENT8NLQ36F6MMGENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]13
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]13
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHGENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CGENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]13
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFGENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]13
Gentamicin SulfateACTIVE INGREDIENT8X7386QRLVGENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH]4
GentamicinACTIVE MOIETYT6Z9V48IKGGENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH]4
EDETATE DISODIUM ANHYDROUSINACTIVE INGREDIENT8NLQ36F6MMGENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH]4
NITROGENINACTIVE INGREDIENTN762921K75GENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH]4
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHGENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH]4
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IGENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH]4
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CGENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH]4
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFGENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [CARDINAL HEALTH]4
Gentamicin SulfateACTIVE INGREDIENT8X7386QRLVGENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [GENERAL INJECTABLES & VACCINES, INC]1
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVGENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]1
GentamicinACTIVE MOIETYT6Z9V48IKGGENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE [GENERAL INJECTABLES & VACCINES, INC]1
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]1
EDETATE DISODIUM ANHYDROUSINACTIVE INGREDIENT8NLQ36F6MMGENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHGENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CGENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]1
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFGENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]1

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 1 of 14 · 274 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PollutoxACETONE, ARSENICUM ALBUM, BENZINUM, BERBERIS VULGARIS, CADMIUM SULPHURATUM, CARBON DIOXIDE, CARBONEUM SULPHURATUM, CHLORINUM, HYDROFLUORICUM ACIDUM, MELATONIN, MERCURIUS SOLUBILIS, NITROGENUM OXYGENATUM, NUX VOMICA, OZONE, PETROLEUM, PLUMBUM METALLICUM, STANNUM METALLICUM, SULPHURICUM ACIDUM, TOLUENE, URANIUM NITRICUMDeseret Biologicals, Inc.741fdddf-75af-45a2-9875-ee3b08b0decf2026-09-08WarningsExact identifier
unii: O40UQP6WCF
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
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, OZONE, URANIUM NITRICUMDeseret Biologicals, Inc.e7000300-69ec-47db-8059-3f873d64f1772026-07-31WarningsExact identifier
unii: O40UQP6WCF
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM98 DROPSACID SULPH, AMYL NITROSUM, AQUILEGIA, CIMICIFUGA, PULSATILLA, SANGUINARIA, SABINABM Private Limited540bf4ca-c217-1aa1-e063-6394a90ab6402026-06-12WarningsExact identifier
unii: O40UQP6WCF

Reported adverse events (FAERS/openFDA)#

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