FDA.reportPublic FDA data

1.8 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Cartridge [Vivacaine]

RxCUI
1012461
RxNorm name
1.8 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Cartridge [Vivacaine]
Display name
VIVACAINE (Injectable)
Full name
1.8 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Cartridge [Vivacaine]
Term type
SBD
Status
Active
Strength
5-0.005 mg/ml
Dose form
Cartridge 1.8 ml
Route
Injectable
Updated
2026-10-27 17:47:14

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
102010
Active start
102010
Multiple ingredient
YES
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
bupivacaine hydrochloride5 MG / 1 MLbupivacainebupivacaine hydrochloride
epinephrine bitartrate5 MCG / 1 MLepinephrineepinephrine

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Cartridge1649572

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
bupivacaine1815
epinephrine3992

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRVivacaine (BUPivacaine HCl 5 % / EPINEPHrine (as EPINEPHrine bitartrate) 1:200,000) in 1.8 mL Cartridge1NAMES
RxNorm Name1.8 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Cartridge [Vivacaine]1NAMES
RxNorm SynonymVivacaine (bupivacaine HCl 5 % / epinephrine (as epinephrine bitartrate) 1:200,000) in 1.8 mL Cartridge1NAMES
TTYSBD1ATTRIBUTES
SPL_SET_IDb4c60d8e-e350-45b2-9d6b-5815eeb6c9941CODES
RxCUI10124611CODES
MMSL_CODEBD10751CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0362-9011-500362-9011Vivacaine bupivacaine hydrochloride and epinephrine bitartrateSeptodont, Inc.ANDA077250

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA0772500362-9011Vivacaine bupivacaine hydrochloride and epinephrine bitartrateANDASeptodont, Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 2 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00362901150rxnav_ndcsyes
00362901110rxnav_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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VivacaineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATESeptodont, Inc.b4c60d8e-e350-45b2-9d6b-5815eeb6c9942024-02-16Warnings, Adverse reactionsExact identifier
ndc (package): 0362-9011-50
ndc (product): 0362-9011
ndc11 (package): 00362901150
rxcui: 1012461

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 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
b4c60d8e-e350-45b2-9d6b-5815eeb6c994Vivacaine 5 % / EPINEPHrine 1:200,000 in 1.8 ML Dental Cartridge [PSN] · 1.8 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Cartridge [Vivacaine] [SBD] · Vivacaine (bupivacaine HCl 5 % / epinephrine (as epinephrine bitartrate) 1:200,000) in 1.8 mL Cartridge [SY]311Vivacaine® Bupivacaine HCl 0.5% (5 mg/mL) and Epinephrine 1:200,000 Injection (as bitartrate) (Bupivacaine Hydrochloride and Epinephrine Injection, USP)20240216

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
b4c60d8e-e350-45b2-9d6b-5815eeb6c994Vivacaine® Bupivacaine HCl 0.5% (5 mg/mL) and Epinephrine 1:200,000 Injection (as bitartrate) (Bupivacaine Hydrochloride and Epinephrine Injection, USP)Septodont, Inc. | Novocol Pharmaceutical of Canada, Inc.20240216
7257e8e4-9007-408c-9a9b-109bdd1d6d1eVivacaine ™ Bupivacaine HCl 0.5% and Epinephrine 1:200,000 Injection (as bitartrate) (Bupivacaine Hydrochloride and Epinephrine Injection, USP)Septodont Inc. | Novocol Pharmaceutical of Canada, Inc.20100629

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCC01CAAdrenergic and dopaminergic agentsATC1-4epinephrine
ATCR03AAAlpha- and beta-adrenoreceptor agonistsATC1-4epinephrine
ATCN01BBAmidesATC1-4bupivacaine
ATCB02BCLocal hemostaticsATC1-4epinephrine
ATCA01ADOther agents for local oral treatmentATC1-4epinephrine
ATCS01EASympathomimetics in glaucoma therapyATC1-4epinephrine
ATCR01AASympathomimetics, plainATC1-4epinephrine
FDASPLD000577AmidesCHEMhas_chemical_structurebupivacaine
FDASPLD002395CatecholaminesCHEMhas_chemical_structureepinephrine
FDASPLN0000175552alpha-Adrenergic AgonistEPChas_epcepinephrine
FDASPLN0000175682Amide Local AnestheticEPChas_epcbupivacaine
FDASPLN0000175555beta-Adrenergic AgonistEPChas_epcepinephrine
FDASPLN0000175570CatecholamineEPChas_epcepinephrine
FDASPLN0000000209Adrenergic alpha-AgonistsMOAhas_moaepinephrine
FDASPLN0000000245Adrenergic beta-AgonistsMOAhas_moaepinephrine
FDASPLN0000175976Local AnesthesiaPEhas_pebupivacaine
MEDRTD002045BupivacaineCHEMhas_ingredientbupivacaine
MEDRTD002045BupivacaineCHEMhas_ingredientbupivacaine hydrochloride
MEDRTD004837EpinephrineCHEMhas_ingredientepinephrine
MEDRTD000402Airway ObstructionDISEASEmay_treatepinephrine
MEDRTD000707AnaphylaxisDISEASEmay_treatepinephrine
MEDRTD001145Arrhythmias, CardiacDISEASEci_withepinephrine
MEDRTD001919BradycardiaDISEASEmay_treatepinephrine
MEDRTD001986Bronchial SpasmDISEASEmay_treatepinephrine
MEDRTD004342Drug HypersensitivityDISEASEci_withbupivacaine
MEDRTD004342Drug HypersensitivityDISEASEci_withepinephrine
MEDRTD004342Drug HypersensitivityDISEASEci_withbupivacaine hydrochloride
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withepinephrine
MEDRTD005902Glaucoma, Open-AngleDISEASEmay_treatepinephrine
MEDRTD006323Heart ArrestDISEASEmay_treatepinephrine
MEDRTD006327Heart BlockDISEASEmay_treatepinephrine
MEDRTD007022HypotensionDISEASEmay_treatepinephrine
MEDRTD010146PainDISEASEmay_preventbupivacaine hydrochloride
MEDRTD010146PainDISEASEmay_preventbupivacaine
MEDRTD010149Postoperative PainDISEASEmay_treatbupivacaine hydrochloride
MEDRTD010149Postoperative PainDISEASEmay_treatbupivacaine
MEDRTD012772Shock, SepticDISEASEmay_treatepinephrine
MEDRTD017180Tachycardia, VentricularDISEASEmay_treatepinephrine
MEDRTD014693Ventricular FibrillationDISEASEmay_treatepinephrine
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaepinephrine
MEDRTN0000009921Adrenergic beta1-AgonistsMOAhas_moaepinephrine
MEDRTN0000009922Adrenergic beta2-AgonistsMOAhas_moaepinephrine
MEDRTN0000000108Prostaglandin Receptor AntagonistsMOAhas_moabupivacaine hydrochloride
MEDRTN0000000108Prostaglandin Receptor AntagonistsMOAhas_moabupivacaine
MEDRTN0000000180Sodium Channel InteractionsMOAhas_moabupivacaine hydrochloride
MEDRTN0000000180Sodium Channel InteractionsMOAhas_moabupivacaine
MEDRTN0000008298Arterial VasoconstrictionPEhas_peepinephrine
MEDRTN0000008322BronchodilationPEhas_peepinephrine
MEDRTN0000009944Decreased Intraocular Aqueous SecretionPEhas_peepinephrine
MEDRTN0000008768Decreased Organized Electrical ActivityPEhas_pebupivacaine hydrochloride
MEDRTN0000008768Decreased Organized Electrical ActivityPEhas_pebupivacaine
MEDRTN0000009014Decreased Uterine Smooth Muscle Contraction or TonePEhas_peepinephrine
MEDRTN0000009070Hemostasis AlterationPEhas_peepinephrine
MEDRTN0000178478Increased Blood PressurePEhas_peepinephrine
MEDRTN0000175976Local AnesthesiaPEhas_pebupivacaine hydrochloride
MEDRTN0000175976Local AnesthesiaPEhas_pebupivacaine
MEDRTN0000009808Positive ChronotropyPEhas_peepinephrine
MEDRTN0000009809Positive InotropyPEhas_peepinephrine
MEDRTN0000009820Pupillary DilationPEhas_peepinephrine

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH5 MG/ML / 0.005 MG/ML
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESQUANTITY1.8 ML
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA077250
NAMESPrescribable SynonymVivacaine 5 % / EPINEPHrine 1:200,000 in 1.8 ML Dental Cartridge
NAMESTallman Synonym1.8 ML BUPivacaine hydrochloride 5 MG/ML / EPINEPHrine 0.005 MG/ML Cartridge [Vivacaine]
NAMESTallman SynonymVivacaine (BUPivacaine HCl 5 % / EPINEPHrine (as EPINEPHrine bitartrate) 1:200,000) in 1.8 mL Cartridge
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMultum MediSource Lexicon