FDA.reportPublic FDA data

bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injectable Solution [Marcaine with Epinephrine]

RxCUI
1012388
RxNorm name
bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injectable Solution [Marcaine with Epinephrine]
Display name
MARCAINE WITH EPINEPHrine (Injectable)
Full name
bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injectable Solution [Marcaine with Epinephrine]
Term type
SBD
Status
Active
Strength
5-0.005 mg/ml
Dose form
Sol
Route
Injectable
Updated
2026-10-27 17:46:17

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
Injectable Solution316949

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
bupivacaine1815
epinephrine3992

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRMarcaine 0.5 % / EPINEPHrine 1:200,000 Injectable Solution1NAMES
RxNorm Namebupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injectable Solution [Marcaine with Epinephrine]1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID
2 linked values
2CODES
RxCUI10123881CODES
MMSL_CODEMTH_RXN_BD10751CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0409-1755-500409-1755Marcaine with Epinephrine BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHospira, Inc.NDA016964
0409-6581-010409-6581Marcaine with Epinephrine BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEHospira, Inc.NDA016964

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA0169640409-1755Marcaine with Epinephrine BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATENDAHospira, Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 25 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00409175550rxnav_ndcsyes
00409658101rxnav_ndcsyes
58472023050rxnav_ndcsyes
00024122302rxnav_historical
00024122303rxnav_historical
00024122310rxnav_historical
00024122330rxnav_historical
00024122801rxnav_historical
00074174903rxnav_historical
00074174910rxnav_historical
00074174929rxnav_historical
00074174930rxnav_historical
00074175550rxnav_historical
00247137850rxnav_historical
00409174903rxnav_historical
00409174910rxnav_historical
00409174929rxnav_historical
00409174970rxnav_historical
00409174971rxnav_historical
31382055705rxnav_historical
49999042050rxnav_historical
54569221400rxnav_historical
54868313403rxnav_historical
54868343900rxnav_historical
58472055705rxnav_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
Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEHospira, Inc.93cf0914-de08-4ec6-8f8c-d663243b99582024-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 0409-6581-01
ndc (product): 0409-6581
ndc11 (package): 00409658101
rxcui: 1012388

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 · 3 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
67578b56-7540-487e-1fba-481255620e78Marcaine 0.5 % / EPINEPHrine 1:200,000 Injectable Solution [PSN] · bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injectable Solution [Marcaine with Epinephrine] [SBD] · Marcaine 0.5 % / epinephrine 1:200,000 Injectable Solution [SY] · Marcaine with Epinephrine 0.5/1:200000 (bupivacaine hydrochloride / epinephrine (as epinephrine bitartrate) ) Injectable Solution [SY]438These 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
93cf0914-de08-4ec6-8f8c-d663243b9958Marcaine 0.5 % / EPINEPHrine 1:200,000 Injectable Solution [PSN] · bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injectable Solution [Marcaine with Epinephrine] [SBD] · Marcaine 0.5 % / epinephrine 1:200,000 Injectable Solution [SY] · Marcaine with Epinephrine 0.5/1:200000 (bupivacaine hydrochloride / epinephrine (as epinephrine bitartrate) ) Injectable Solution [SY]45These 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
6a60cb55-530a-41ee-bc78-971eaf9f0850Marcaine 0.5 % / EPINEPHrine 1:200,000 Injectable Solution [PSN] · bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injectable Solution [Marcaine with Epinephrine] [SBD] · Marcaine 0.5 % / epinephrine 1:200,000 Injectable Solution [SY] · Marcaine with Epinephrine 0.5/1:200000 (bupivacaine hydrochloride / epinephrine (as epinephrine bitartrate) ) Injectable Solution [SY]4420120307

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
67578b56-7540-487e-1fba-481255620e78These 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: 1972Hospira, Inc. | Pfizer Healthcare India Private Limited20261023
67578b56-7540-487e-1fba-481255620e78These 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: 1972Hospira, Inc. | Pfizer Healthcare India Private Limited20261014
67578b56-7540-487e-1fba-481255620e78These 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: 1972Hospira, Inc. | Pfizer Healthcare India Private Limited20260529
67578b56-7540-487e-1fba-481255620e78These 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: 1972Hospira, Inc. | Pfizer Healthcare India Private Limited20260423
67578b56-7540-487e-1fba-481255620e78These 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: 1972Hospira, Inc. | Pfizer Healthcare India Private Limited20251106
67578b56-7540-487e-1fba-481255620e78These 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: 1972Hospira, Inc. | Pfizer Healthcare India Private Limited20250828
67578b56-7540-487e-1fba-481255620e78These 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: 1972Hospira, Inc. | Pfizer Healthcare India Private Limited20250825
93cf0914-de08-4ec6-8f8c-d663243b9958These 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: 1972Hospira, Inc. | Standard Chem. & Pharm. Co., Ltd. Plant II20240202
63840275-9158-466c-8a2b-f9b06a236ab2Marcaine® 0.5% with epinephrine 1:200,000 injection (as bitartrate) (bupivacaine hydrochloride and epinephrine injection, USP)Carestream Health Inc. | Novocol Pharmaceutical of Canada, Inc.20130601
1f55f96c-4364-43d3-aff1-5508ca028306National Council for Prescription Drug Programs20120724
4e17f954-60e0-48e5-9229-aedcda130135National Council for Prescription Drug Programs20120724
67701e68-cba3-4bc8-907e-783a3d2c316bNational Council for Prescription Drug Programs20120724
7976a937-5080-42c8-a0ba-a5fd0ed552edNational Council for Prescription Drug Programs20120724
6a60cb55-530a-41ee-bc78-971eaf9f0850Physicians Total Care, Inc.20120307

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
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESNDANDA016964
NAMESPrescribable SynonymMarcaine 0.5 % / EPINEPHrine 1:200,000 Injectable Solution
NAMESTallman SynonymBUPivacaine hydrochloride 5 MG/ML / EPINEPHrine 0.005 MG/ML Injectable Solution [Marcaine with EPINEPHrine]
NAMESTallman SynonymMarcaine 0.5 % / EPINEPHrine 1:200,000 Injectable Solution
NAMESTallman SynonymMarcaine with EPINEPHrine 0.5/1:200000 (BUPivacaine hydrochloride / EPINEPHrine (as EPINEPHrine bitartrate) ) Injectable Solution
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon