FDA.reportPublic FDA data

10 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injection

RxCUI
1867594
RxNorm name
10 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injection
Display name
BUPivacaine/EPINEPHrine (Injectable)
Full name
10 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injection
Term type
SCD
Status
Active
Strength
2.5-0.005 mg/ml
Dose form
Injection 10 ml
Route
Injectable
Updated
2026-10-27 17:49:47

RxNorm Status History#

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

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
bupivacaine hydrochloride2.5 MG / 1 MLbupivacainebupivacaine hydrochloride
epinephrine bitartrate5 MCG / 1 MLepinephrineepinephrine

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Injection1649574

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
bupivacaine1815
epinephrine3992

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STR10 ML BUPivacaine hydrochloride 2.5 MG/ML / EPINEPHrine 0.005 MG/ML Injection1NAMES
RxNorm Name10 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injection1NAMES
RxNorm Synonymbupivacaine HCl 0.25 % / epinephrine (as bitartrate) 1:200,000 per 10 mL Injection1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID02a845c3-4521-4926-e397-25ab536e7cf61CODES
RxCUI18675941CODES
MMSL_CODEMTH_RXN_BD149371CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0409-9042-010409-9042Bupivacaine Hydrochloride and Epinephrine BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEHospira, Inc.ANDA071165

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA0711650409-9042Bupivacaine Hydrochloride and Epinephrine BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEANDAHospira, Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 3 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00409904201rxnav_ndcsyes
00409904211rxnav_ndcsyes
55154474605rxnav_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
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEHospira, Inc.02a845c3-4521-4926-e397-25ab536e7cf62026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 0409-9042-01
ndc (product): 0409-9042
ndc11 (package): 00409904211
ndc11 (package): 00409904201
rxcui: 1867594
SENSORCAINE MPFBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCb671015d-f620-4930-a890-5e27a40ae42f2024-11-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1867594
Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEHospira, Inc.93cf0914-de08-4ec6-8f8c-d663243b99582024-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1867594
SENSORCAINEBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb2023-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1867594

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
02a845c3-4521-4926-e397-25ab536e7cf6BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 in 10 ML Injection [PSN] · 10 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injection [SCD] · bupivacaine HCl 0.25 % / epinephrine (as bitartrate) 1:200,000 per 10 mL Injection [SY]339These highlights do not include all the information needed to use BUPIVACAINE HYDROCHLORIDE INJECTION and BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION safely and effectively. See full prescribing information for BUPIVACAINE HYDROCHLORIDE INJECTION and BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION. BUPIVACAINE HYDROCHLORIDE injection, for infiltration, perineural, caudal, epidural, or retrobulbar use BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE injection, for infiltration, perineural, caudal, or ep20260309
67578b56-7540-487e-1fba-481255620e78BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 in 10 ML Injection [PSN] · 10 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injection [SCD] · bupivacaine HCl 0.25 % / epinephrine (as bitartrate) 1:200,000 per 10 mL Injection [SY]338These highlights do not include all the information needed to use MARCAINE™ and MARCAINE™ WITH EPINEPHRINE safely and effectively. See full prescribing information for MARCAINE™ and MARCAINE™ WITH EPINEPHRINE. MARCAINE™ (bupivacaine hydrochloride) injection, for infiltration, perineural, caudal, epidural, or retrobulbar use MARCAINE™ WITH EPINEPHRINE (bupivacaine hydrochloride and epinephrine) injection, for infiltration, perineural, caudal, or epidural use Initial U.S. Approval: 197220260529
bc61a9a6-0a4e-48a9-b908-e5e66b9f23ebBUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 in 10 ML Injection [PSN] · 10 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injection [SCD] · bupivacaine HCl 0.25 % / epinephrine (as bitartrate) 1:200,000 per 10 mL Injection [SY]37These highlights do not include all the information needed to use SENSORCAINE ® -MPF, SENSORCAINE ® -MPF WITH EPINEPHRINE, SENSORCAINE ® , and SENSORCAINE ® WITH EPINEPHRINE, safely and effectively. See full prescribing information for SENSORCAINE ® -MPF, SENSORCAINE ® -MPF WITH EPINEPHRINE, SENSORCAINE ® , and SENSORCAINE ® WITH EPINEPHRINE. SENSORCAINE ® -MPF (bupivacaine hydrochloride) injection, for infiltration, perineural, caudal, epidural, or retrobulbar use SENSORCAINE ® -MPF WITH EPINEPHRINE (bupiv20230430
93cf0914-de08-4ec6-8f8c-d663243b9958BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 in 10 ML Injection [PSN] · 10 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injection [SCD] · bupivacaine HCl 0.25 % / epinephrine (as bitartrate) 1:200,000 per 10 mL Injection [SY]35These highlights do not include all the information needed to use MARCAINE™ and MARCAINE™ WITH EPINEPHRINE safely and effectively. See full prescribing information for MARCAINE™ and MARCAINE™ WITH EPINEPHRINE. MARCAINE™ (bupivacaine hydrochloride) injection, for infiltration, perineural, caudal, epidural, or retrobulbar use MARCAINE™ WITH EPINEPHRINE (bupivacaine hydrochloride and epinephrine) injection, for infiltration, perineural, caudal, or epidural use Initial U.S. Approval: 197220240202
b671015d-f620-4930-a890-5e27a40ae42fBUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 in 10 ML Injection [PSN] · 10 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injection [SCD] · bupivacaine HCl 0.25 % / epinephrine (as bitartrate) 1:200,000 per 10 mL Injection [SY]31Sensorcaine ® -MPF (bupivacaine HCl Injection, USP) Sensorcaine ® -MPF with Epinephrine (bupivacaine HCl and epinephrine Injection, USP) 1:200,000 (as bitartrate)20241125

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
02a845c3-4521-4926-e397-25ab536e7cf6These highlights do not include all the information needed to use BUPIVACAINE HYDROCHLORIDE INJECTION and BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION safely and effectively. See full prescribing information for BUPIVACAINE HYDROCHLORIDE INJECTION and BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION. BUPIVACAINE HYDROCHLORIDE injection, for infiltration, perineural, caudal, epidural, or retrobulbar use BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE injection, for infiltration, perineural, caudal, or epHospira, Inc. | Pfizer Healthcare India Private Limited20260309
3a365cc7-1916-4972-b42c-6320b86cabd5National Council for Prescription Drug Programs20120724

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_STRENGTH2.5 MG/ML / 0.005 MG/ML
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESQUANTITY10 ML
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA071165
CODESVUID4004274
NAMESPrescribable SynonymBUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 in 10 ML Injection
NAMESTallman Synonym10 ML BUPivacaine hydrochloride 2.5 MG/ML / EPINEPHrine 0.005 MG/ML Injection
NAMESTallman SynonymBUPivacaine HCl 0.25 % / EPINEPHrine (as bitartrate) 1:200,000 per 10 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