FDA.reportPublic FDA data

50 ML lidocaine hydrochloride 5 MG/ML Injection

RxCUI
1737343
RxNorm name
50 ML lidocaine hydrochloride 5 MG/ML Injection
Display name
Lidocaine (Injectable)
Full name
50 ML lidocaine hydrochloride 5 MG/ML Injection
Term type
SCD
Status
Active
Strength
5 mg/ml
Dose form
Injection 50 ml
Route
Injectable
Updated
2026-10-21 00:31:56

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
032016
Active start
032016
Multiple ingredient
NO
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
lidocaine hydrochloride5 MG / 1 MLlidocainelidocaine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Injection1649574

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
lidocaine6387

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STR50 ML lidocaine hydrochloride 5 MG/ML Injection1NAMES
RxNorm Name50 ML lidocaine hydrochloride 5 MG/ML Injection1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
3 linked values
3CODES
RxCUI17373431CODES
MMSL_CODEBD149401CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0404-9885-500404-9885LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDEHenry Schein, Inc.ANDA088328
0409-4278-010409-4278Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDEHospira, Inc.ANDA088328
51662-1600-351662-16000.5% LIDOCAINE HCl 0.5% LIDOCAINE HClHF Acquisition Co LLC, DBA HealthFirstANDA088328

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA0883280404-9885LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDEANDAHenry Schein, Inc.

RxNav Current And Historical NDCs#

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

NDC11, Source, Active table
NDC11SourceActive
00404988550rxnav_ndcsyes
00409427801rxnav_ndcsyes
00409427816rxnav_ndcsyes
51662160002rxnav_ndcsyes
51662160003rxnav_ndcsyes
52584027816rxnav_historical
55154698408rxnav_historical
67457051052rxnav_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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XYLOCAINE MPFLIDOCAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst1986c302-82a0-95a9-e063-6294a90a33392026-09-02Warnings, Adverse reactionsExact identifier
rxcui: 1737343
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.3b2dd84e-cee8-4e58-d494-395a65a353a02026-08-05Warnings, Adverse reactionsExact identifier
ndc (package): 0409-4278-01
ndc (product): 0409-4278
ndc11 (package): 00409427816
ndc11 (package): 00409427801
rxcui: 1737343
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHenry Schein, Inc.ee21518e-b3ed-405a-ac3b-bfe753893dba2025-09-29Warnings, Adverse reactionsExact identifier
ndc (package): 0404-9885-50
ndc (product): 0404-9885
ndc11 (package): 00404988550
rxcui: 1737343
0.5% LIDOCAINE HCl0.5% LIDOCAINE HCLHF Acquisition Co LLC, DBA HealthFirste52fe254-8872-35ce-e053-2a95a90a339e2024-01-27Warnings, Adverse reactionsExact identifier
ndc (package): 51662-1600-3
ndc (product): 51662-1600
ndc11 (package): 51662160002
ndc11 (package): 51662160003
rxcui: 1737343
XylocaineLIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCba082c2f-64f4-419d-9c88-74f203316e172021-08-25Warnings, Adverse reactionsExact identifier
rxcui: 1737343

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 · 5 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
3b2dd84e-cee8-4e58-d494-395a65a353a0lidocaine HCl 0.5 % in 50 ML Injection [PSN] · 50 ML lidocaine hydrochloride 5 MG/ML Injection [SCD] · lidocaine HCl 0.5 % per 50 ML Injection [SY] · lidocaine HCl 250 MG per 50 ML Injection [SY]446These highlights do not include all the information needed to use LIDOCAINE HYDROCHLORIDE INJECTION, USP safely and effectively. See full prescribing information for LIDOCAINE HYDROCHLORIDE INJECTION, USP. LIDOCAINE HYDROCHLORIDE INJECTION, USP, aqueous solutions for infiltration and nerve block Initial U.S. Approval: 194820260116
ba082c2f-64f4-419d-9c88-74f203316e17lidocaine HCl 0.5 % in 50 ML Injection [PSN] · 50 ML lidocaine hydrochloride 5 MG/ML Injection [SCD] · lidocaine HCl 0.5 % per 50 ML Injection [SY] · lidocaine HCl 250 MG per 50 ML Injection [SY]413Xylocaine® (lidocaine HCl Injection, USP) Xylocaine® (lidocaine HCl and epinephrine Injection, USP)20210825
ee21518e-b3ed-405a-ac3b-bfe753893dbalidocaine HCl 0.5 % in 50 ML Injection [PSN] · 50 ML lidocaine hydrochloride 5 MG/ML Injection [SCD] · lidocaine HCl 0.5 % per 50 ML Injection [SY] · lidocaine HCl 250 MG per 50 ML Injection [SY]46Lidocaine Hydrochloride Injection, USP AQUEOUS SOLUTIONS FOR INFILTRATION AND NERVE BLOCK Ampul Plastic Multiple-Dose Fliptop Vial Glass Teartop Vial Rx only20250929
1986c302-82a0-95a9-e063-6294a90a3339lidocaine HCl 0.5 % in 50 ML Injection [PSN] · 50 ML lidocaine hydrochloride 5 MG/ML Injection [SCD] · lidocaine HCl 0.5 % per 50 ML Injection [SY] · lidocaine HCl 250 MG per 50 ML Injection [SY]4320241115
e52fe254-8872-35ce-e053-2a95a90a339elidocaine HCl 0.5 % in 50 ML Injection [PSN] · 50 ML lidocaine hydrochloride 5 MG/ML Injection [SCD] · lidocaine HCl 0.5 % per 50 ML Injection [SY] · lidocaine HCl 250 MG per 50 ML Injection [SY]420.5% LIDOCAINE HCl INJECTION, USP 250mg/50mL (5mg/mL)20240127

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
3b2dd84e-cee8-4e58-d494-395a65a353a0These highlights do not include all the information needed to use LIDOCAINE HYDROCHLORIDE INJECTION, USP safely and effectively. See full prescribing information for LIDOCAINE HYDROCHLORIDE INJECTION, USP. LIDOCAINE HYDROCHLORIDE INJECTION, USP, aqueous solutions for infiltration and nerve block Initial U.S. Approval: 1948Hospira, Inc. | Pfizer Healthcare India Private Limited20260805
3b2dd84e-cee8-4e58-d494-395a65a353a0These highlights do not include all the information needed to use LIDOCAINE HYDROCHLORIDE INJECTION, USP safely and effectively. See full prescribing information for LIDOCAINE HYDROCHLORIDE INJECTION, USP. LIDOCAINE HYDROCHLORIDE INJECTION, USP, aqueous solutions for infiltration and nerve block Initial U.S. Approval: 1948Hospira, Inc. | Pfizer Healthcare India Private Limited20260116
3b2dd84e-cee8-4e58-d494-395a65a353a0Lidocaine Hydrochloride Injection, USPHospira, Inc. | Pfizer Healthcare India Private Limited20251005
ee21518e-b3ed-405a-ac3b-bfe753893dbaLidocaine Hydrochloride Injection, USP AQUEOUS SOLUTIONS FOR INFILTRATION AND NERVE BLOCK Ampul Plastic Multiple-Dose Fliptop Vial Glass Teartop Vial Rx onlyHenry Schein, Inc.20250929
3b2dd84e-cee8-4e58-d494-395a65a353a0Lidocaine Hydrochloride Injection, USPHospira, Inc. | Pfizer Healthcare India Private Limited20241203
e52fe254-8872-35ce-e053-2a95a90a339e0.5% LIDOCAINE HCl INJECTION, USP 250mg/50mL (5mg/mL)HF Acquisition Co LLC, DBA HealthFirst20240127
51da3799-4346-406c-8f90-f55e5d7ed40eLidocaine Hydrochloride Injection, USP AQUEOUS SOLUTIONS FOR INFILTRATION AND NERVE BLOCK Ampul Plastic Multiple-Dose Fliptop Vial Glass Teartop Vial Rx onlyGeneral Injectables and Vaccines, Inc.20221222
e972ed0a-e278-4d99-83ec-2b29c680e040National Council for Prescription Drug Programs20120724

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCN01BBAmidesATC1-4lidocaine
ATCS02DAAnalgesics and anestheticsATC1-4lidocaine
ATCD04ABAnesthetics for topical useATC1-4lidocaine
ATCR02ADAnesthetics, localATC1-4lidocaine
ATCC01BBAntiarrhythmics, class IbATC1-4lidocaine
ATCS01HALocal anestheticsATC1-4lidocaine
ATCC05ADLocal anestheticsATC1-4lidocaine
FDASPLN0000175682Amide Local AnestheticEPChas_epclidocaine
FDASPLN0000175426AntiarrhythmicEPChas_epclidocaine
FDASPLN0000175976Local AnesthesiaPEhas_pelidocaine
MEDRTD008012LidocaineCHEMhas_ingredientlidocaine hydrochloride
MEDRTD008012LidocaineCHEMhas_ingredientlidocaine
MEDRTD000219Adams-Stokes SyndromeDISEASEci_withlidocaine hydrochloride
MEDRTD000219Adams-Stokes SyndromeDISEASEci_withlidocaine
MEDRTD002056BurnsDISEASEmay_treatlidocaine hydrochloride
MEDRTD002056BurnsDISEASEmay_treatlidocaine
MEDRTD004342Drug HypersensitivityDISEASEci_withlidocaine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withlidocaine
MEDRTD064420Drug-Related Side Effects and Adverse ReactionsDISEASEmay_treatlidocaine
MEDRTD064420Drug-Related Side Effects and Adverse ReactionsDISEASEmay_treatlidocaine hydrochloride
MEDRTD004935Esophageal DiseasesDISEASEmay_treatlidocaine
MEDRTD004935Esophageal DiseasesDISEASEmay_treatlidocaine hydrochloride
MEDRTD006967HypersensitivityDISEASEci_withlidocaine hydrochloride
MEDRTD006967HypersensitivityDISEASEci_withlidocaine
MEDRTD009059Mouth DiseasesDISEASEmay_treatlidocaine hydrochloride
MEDRTD009059Mouth DiseasesDISEASEmay_treatlidocaine
MEDRTD009203Myocardial InfarctionDISEASEmay_treatlidocaine hydrochloride
MEDRTD010146PainDISEASEmay_preventlidocaine hydrochloride
MEDRTD010146PainDISEASEmay_preventlidocaine
MEDRTD010146PainDISEASEmay_treatlidocaine
MEDRTD010146PainDISEASEmay_treatlidocaine hydrochloride
MEDRTD013614Tachycardia, ParoxysmalDISEASEmay_treatlidocaine
MEDRTD013614Tachycardia, ParoxysmalDISEASEmay_treatlidocaine hydrochloride
MEDRTD017180Tachycardia, VentricularDISEASEmay_treatlidocaine hydrochloride
MEDRTD017180Tachycardia, VentricularDISEASEmay_treatlidocaine
MEDRTD018754Ventricular DysfunctionDISEASEmay_treatlidocaine hydrochloride
MEDRTD014693Ventricular FibrillationDISEASEmay_treatlidocaine
MEDRTD014693Ventricular FibrillationDISEASEmay_treatlidocaine hydrochloride
MEDRTD018879Ventricular Premature ComplexesDISEASEmay_treatlidocaine
MEDRTD018879Ventricular Premature ComplexesDISEASEmay_treatlidocaine hydrochloride
MEDRTN0000000180Sodium Channel InteractionsMOAhas_moalidocaine
MEDRTN0000000180Sodium Channel InteractionsMOAhas_moalidocaine hydrochloride
MEDRTN0000008330Cardiac Rhythm AlterationPEhas_pelidocaine
MEDRTN0000008330Cardiac Rhythm AlterationPEhas_pelidocaine hydrochloride
MEDRTN0000008472Decreased Cardiac Muscle Organized Electrical ActivityPEhas_pelidocaine
MEDRTN0000008472Decreased Cardiac Muscle Organized Electrical ActivityPEhas_pelidocaine hydrochloride
MEDRTN0000008889Decreased Sensory-Somatic Nervous System Organized Electrical ActivityPEhas_pelidocaine
MEDRTN0000008889Decreased Sensory-Somatic Nervous System Organized Electrical ActivityPEhas_pelidocaine hydrochloride
MEDRTN0000175976Local AnesthesiaPEhas_pelidocaine
MEDRTN0000175976Local AnesthesiaPEhas_pelidocaine hydrochloride

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH5 MG/ML
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESQUANTITY50 ML
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA088328
CODESVUID4015604
NAMESPrescribable Synonymlidocaine HCl 0.5 % in 50 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