FDA.reportPublic FDA data

2 ML gentamicin 10 MG/ML Injection

RxCUI
1870676
RxNorm name
2 ML gentamicin 10 MG/ML Injection
Display name
Gentamicin (Injectable)
Full name
2 ML gentamicin 10 MG/ML Injection
Term type
SCD
Status
Active
Strength
10 mg/ml
Dose form
Injection 2 ml
Route
Injectable
Updated
2026-10-27 19:29:29

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
032017
Active start
032017
Multiple ingredient
NO
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
gentamicin sulfate10 MG / 1 MLgentamicingentamicin

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Injection1649574

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
gentamicin1596450

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STR2 ML gentamicin 10 MG/ML Injection1NAMES
RxNorm Name2 ML gentamicin 10 MG/ML Injection1NAMES
RxNorm Synonymgentamicin (as gentamicin sulfate) 20 MG per 2 ML Injection1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
4 linked values
4CODES
RxCUI18706761CODES
MMSL_CODEBD12801CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
55150-401-2555150-401Gentamicin GentamicinEugia US LLCANDA215236
63323-173-0263323-173Gentamicin GENTAMICINFresenius Kabi USA, LLCANDA062366
63323-173-9463323-173Gentamicin GENTAMICINFresenius Kabi USA, LLCANDA062366
63323-173-9563323-173Gentamicin GENTAMICINFresenius Kabi USA, LLCANDA062366

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA21523655150-401Gentamicin GentamicinANDAEugia US LLC
ANDA06236663323-173Gentamicin GENTAMICINANDAFresenius Kabi USA, LLC

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 8 matching rows.

NDC11, Source, Active table
NDC11SourceActive
55150040101rxnav_ndcsyes
55150040125rxnav_ndcsyes
63323017301rxnav_ndcsyes
63323017302rxnav_ndcsyes
63323017341rxnav_ndcsyes
63323017394rxnav_ndcsyes
63323017395rxnav_ndcsyes
55154937605rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GentamicinGENTAMICINEugia US LLCf8c608b3-50b8-4d5d-9e8a-e92c0d2e3cdc2026-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 55150-401-25
ndc (product): 55150-401
ndc11 (package): 55150040101
ndc11 (package): 55150040125
rxcui: 1870676
GentamicinGENTAMICINFresenius Kabi USA, LLC63413469-c676-48a3-a945-7d2489b535ef2024-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 63323-173-95
ndc (product): 63323-173
ndc11 (package): 63323017395
rxcui: 1870676
GentamicinGENTAMICINFresenius Kabi USA, LLC8bdeef7f-ad8e-46e0-a872-e945eae51d682023-12-20Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 63323-173-94
ndc (product): 63323-173
ndc11 (package): 63323017341
ndc11 (package): 63323017394
rxcui: 1870676
GentamicinGENTAMICINFresenius Kabi USA, LLCbe5b414e-d598-4721-80ee-5836156ad2102023-10-24Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 63323-173-02
ndc (product): 63323-173
ndc11 (package): 63323017301
ndc11 (package): 63323017302
rxcui: 1870676

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 4 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
be5b414e-d598-4721-80ee-5836156ad210gentamicin sulfate 20 MG in 2 ML Injection [PSN] · 2 ML gentamicin 10 MG/ML Injection [SCD] · gentamicin (as gentamicin sulfate) 20 MG per 2 ML Injection [SY]38Gentamicin Injection, USP (Pediatric)20231024
8bdeef7f-ad8e-46e0-a872-e945eae51d68gentamicin sulfate 20 MG in 2 ML Injection [PSN] · 2 ML gentamicin 10 MG/ML Injection [SCD] · gentamicin (as gentamicin sulfate) 20 MG per 2 ML Injection [SY]34Gentamicin Injection, USP20231220
63413469-c676-48a3-a945-7d2489b535efgentamicin sulfate 20 MG in 2 ML Injection [PSN] · 2 ML gentamicin 10 MG/ML Injection [SCD] · gentamicin (as gentamicin sulfate) 20 MG per 2 ML Injection [SY]33Gentamicin Injection, USP20241014
f8c608b3-50b8-4d5d-9e8a-e92c0d2e3cdcgentamicin sulfate 20 MG in 2 ML Injection [PSN] · 2 ML gentamicin 10 MG/ML Injection [SCD] · gentamicin (as gentamicin sulfate) 20 MG per 2 ML Injection [SY]32Gentamicin Injection, USP (Pediatric) Rx only20260127

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
f8c608b3-50b8-4d5d-9e8a-e92c0d2e3cdcGentamicin Injection, USP (Pediatric) Rx onlyEugia US LLC | EUGIA PHARMA SPECIALITIES LIMITED20260127
63413469-c676-48a3-a945-7d2489b535efGentamicin Injection, USPFresenius Kabi USA, LLC20241014
8bdeef7f-ad8e-46e0-a872-e945eae51d68Gentamicin Injection, USPFresenius Kabi USA, LLC20231220
be5b414e-d598-4721-80ee-5836156ad210Gentamicin Injection, USP (Pediatric)Fresenius Kabi USA, LLC20231024
5fd11ec3-8c33-4c79-b4c7-bec645fb2873National Council for Prescription Drug Programs20120724

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCS01AAAntibioticsATC1-4gentamicin
ATCS03AAAntiinfectivesATC1-4gentamicin
ATCS02AAAntiinfectivesATC1-4gentamicin
ATCJ01GBOther aminoglycosidesATC1-4gentamicin
ATCD06AXOther antibiotics for topical useATC1-4gentamicin
FDASPLD000617AminoglycosidesCHEMhas_chemical_structuregentamicin
FDASPLN0000175477Aminoglycoside AntibacterialEPChas_epcgentamicin
MEDRTD005839GentamicinsCHEMhas_ingredientgentamicin
MEDRTD001850Bone Diseases, InfectiousDISEASEmay_treatgentamicin
MEDRTD002494Central Nervous System InfectionsDISEASEmay_treatgentamicin
MEDRTD004696EndocarditisDISEASEmay_treatgentamicin
MEDRTD004697Endocarditis, BacterialDISEASEmay_preventgentamicin
MEDRTD004927Escherichia coli InfectionsDISEASEmay_treatgentamicin
MEDRTD015818Eye Infections, BacterialDISEASEmay_treatgentamicin
MEDRTD006967HypersensitivityDISEASEci_withgentamicin
MEDRTD007710Klebsiella InfectionsDISEASEmay_treatgentamicin
MEDRTD014395Peritonitis, TuberculousDISEASEmay_treatgentamicin
MEDRTD011512Proteus InfectionsDISEASEmay_treatgentamicin
MEDRTD011552Pseudomonas InfectionsDISEASEmay_treatgentamicin
MEDRTD012141Respiratory Tract InfectionsDISEASEmay_treatgentamicin
MEDRTD018805SepsisDISEASEmay_treatgentamicin
MEDRTD016868Serratia InfectionsDISEASEmay_treatgentamicin
MEDRTD017192Skin Diseases, BacterialDISEASEmay_treatgentamicin
MEDRTD018461Soft Tissue InfectionsDISEASEmay_treatgentamicin
MEDRTD013203Staphylococcal InfectionsDISEASEmay_treatgentamicin
MEDRTD014552Urinary Tract InfectionsDISEASEmay_treatgentamicin
MEDRTN0000000150Protein Synthesis InhibitorsMOAhas_moagentamicin
MEDRTN0000008476Decreased Cell Membrane IntegrityPEhas_pegentamicin
MEDRTN0000008841Decreased Protein SynthesisPEhas_pegentamicin

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH10 MG/ML
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESQUANTITY2 ML
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA062366
CODESANDAANDA215236
CODESVUID4004136
NAMESPrescribable Synonymgentamicin sulfate 20 MG in 2 ML Injection
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceVeterans Health Administration National Drug File