FDA.reportPublic FDA data

bupivacaine hydrochloride 2.5 MG/ML Injectable Solution [Sensorcaine]

RxCUI
1012455
RxNorm name
bupivacaine hydrochloride 2.5 MG/ML Injectable Solution [Sensorcaine]
Display name
SENSORCAINE (Injectable)
Full name
bupivacaine hydrochloride 2.5 MG/ML Injectable Solution [Sensorcaine]
Term type
SBD
Status
Active
Strength
2.5 mg/ml
Dose form
Sol
Route
Injectable
Updated
2026-10-27 17:47:05

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
102010
Active start
102010
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

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

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Injectable Solution316949

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
bupivacaine1815

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRSensorcaine 0.25 % Injectable Solution1NAMES
RxNorm Namebupivacaine hydrochloride 2.5 MG/ML Injectable Solution [Sensorcaine]1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID
2 linked values
2CODES
RxCUI10124551CODES
MMSL_CODEBD10491CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0404-9945-500404-9945Sensorcaine Bupivacaine HydrochlorideHenry Schein, Inc.NDA018304
63323-465-5763323-465SENSORCAINE BUPIVACAINE HYDROCHLORIDEFresenius Kabi USA, LLCNDA018304

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA0183040404-9945Sensorcaine Bupivacaine HydrochlorideNDAHenry Schein, Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 19 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00404994550rxnav_ndcsyes
63323046501rxnav_ndcsyes
63323046557rxnav_ndcsyes
00186103001rxnav_historical
00186103002rxnav_historical
00186103012rxnav_historical
00186103091rxnav_historical
00186103092rxnav_historical
00186103101rxnav_historical
00186103201rxnav_historical_indirect
00186103212rxnav_historical_indirect
52584046557rxnav_historical
63323046410rxnav_historical
63323046417rxnav_historical
63323046430rxnav_historical
63323046431rxnav_historical
63323046433rxnav_historical
63323046437rxnav_historical
63323046550rxnav_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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SensorcaineBUPIVACAINE HYDROCHLORIDEHenry Schein, Inc.2046d833-2974-42fd-a29e-7fc1dc7166cc2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 0404-9945-50
ndc (product): 0404-9945
ndc11 (package): 00404994550
rxcui: 1012455
SENSORCAINE MPFBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCeb6d8fee-def4-4c96-9972-695e8cea8ea82024-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 63323-465-57
ndc (product): 63323-465
ndc11 (package): 63323046431
ndc11 (package): 63323046501
ndc11 (package): 63323046557
ndc11 (package): 63323046437
rxcui: 1012455
Sensorcaine MPFBUPIVACAINE HYDROCHLORIDEFresenius Kabi USA, LLCe700eb7b-8b14-49c9-96b2-331f18776e452023-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
ndc11 (package): 63323046417

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 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
eb6d8fee-def4-4c96-9972-695e8cea8ea8Sensorcaine 0.25 % Injectable Solution [PSN] · bupivacaine hydrochloride 2.5 MG/ML Injectable Solution [Sensorcaine] [SBD] · Sensorcaine 0.25 % Injectable Solution [SY] · Sensorcaine 2.5 MG/ML Injectable Solution [SY]410Sensorcaine ® (bupivacaine HCl Injection, USP) Sensorcaine ® -MPF (bupivacaine HCl Injection, USP) Sensorcaine ® with Epinephrine (bupivacaine HCl and epinephrine Injection, USP) 1:200,000 (as bitartrate) Sensorcaine ® -MPF with Epinephrine (bupivacaine HCl and epinephrine Injection, USP) 1:200,000 (as bitartrate)20241015
2046d833-2974-42fd-a29e-7fc1dc7166ccSensorcaine 0.25 % Injectable Solution [PSN] · bupivacaine hydrochloride 2.5 MG/ML Injectable Solution [Sensorcaine] [SBD] · Sensorcaine 0.25 % Injectable Solution [SY] · Sensorcaine 2.5 MG/ML Injectable Solution [SY]46These 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 (bupivacaine hydrochlorid20251205

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
2046d833-2974-42fd-a29e-7fc1dc7166ccThese 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 (bupivacaine hydrochloridHenry Schein, Inc.20251205
2046d833-2974-42fd-a29e-7fc1dc7166ccSensorcaine 0.25% (Bupivacaine HCl) 50mLHenry Schein, Inc.20251107
eb6d8fee-def4-4c96-9972-695e8cea8ea8Sensorcaine ® (bupivacaine HCl Injection, USP) Sensorcaine ® -MPF (bupivacaine HCl Injection, USP) Sensorcaine ® with Epinephrine (bupivacaine HCl and epinephrine Injection, USP) 1:200,000 (as bitartrate) Sensorcaine ® -MPF with Epinephrine (bupivacaine HCl and epinephrine Injection, USP) 1:200,000 (as bitartrate)Fresenius Kabi USA, LLC20241015
2046d833-2974-42fd-a29e-7fc1dc7166ccSensorcaine 0.25% (Bupivacaine HCl) 50mLHenry Schein, Inc.20240807
e700eb7b-8b14-49c9-96b2-331f18776e45These 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 (bupivFresenius Kabi USA, LLC20230512
e5808712-4487-43b2-891f-e1ef47a9e28dSensorcaine 0.25% (Bupivacaine HCl) 50mLGeneral Injectables & Vaccines, Inc20221229
018101d1-b391-4d43-a136-957d34adf595National Council for Prescription Drug Programs20120724
77835e45-e7a7-46f2-888e-7c68cad0a54cNational Council for Prescription Drug Programs20120724
7879d7bd-f29b-454c-8e67-75d3c38bcf32National Council for Prescription Drug Programs20120724
f9592b4f-7114-4d9a-a869-a2d296abbd2dNational Council for Prescription Drug Programs20120724
fd4dff38-e949-491f-920d-8ed9e60e7ac8National Council for Prescription Drug Programs20120724
961C81A1-4DFC-4CFC-D8AA-94FE79F8B2D2Sensorcaine® (bupivacaine HCl Injection, USP) Sensorcaine®-MPF (bupivacaine HCl Injection, USP) Sensorcaine® with Epinephrine (bupivacaine HCl and epinephrine Injection, USP) 1:200,000 (as bitartrate) Sensorcaine®-MPF with Epinephrine (bupivacaine HCl and epinephrine Injection, USP) 1:200,000 (as bitartrate)AstraZeneca LP20060705

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCN01BBAmidesATC1-4bupivacaine
FDASPLD000577AmidesCHEMhas_chemical_structurebupivacaine
FDASPLN0000175682Amide Local AnestheticEPChas_epcbupivacaine
FDASPLN0000175976Local AnesthesiaPEhas_pebupivacaine
MEDRTD002045BupivacaineCHEMhas_ingredientbupivacaine
MEDRTD002045BupivacaineCHEMhas_ingredientbupivacaine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withbupivacaine
MEDRTD004342Drug HypersensitivityDISEASEci_withbupivacaine hydrochloride
MEDRTD010146PainDISEASEmay_preventbupivacaine
MEDRTD010146PainDISEASEmay_preventbupivacaine hydrochloride
MEDRTD010149Postoperative PainDISEASEmay_treatbupivacaine
MEDRTD010149Postoperative PainDISEASEmay_treatbupivacaine hydrochloride
MEDRTN0000000108Prostaglandin Receptor AntagonistsMOAhas_moabupivacaine
MEDRTN0000000108Prostaglandin Receptor AntagonistsMOAhas_moabupivacaine hydrochloride
MEDRTN0000000180Sodium Channel InteractionsMOAhas_moabupivacaine
MEDRTN0000000180Sodium Channel InteractionsMOAhas_moabupivacaine hydrochloride
MEDRTN0000008768Decreased Organized Electrical ActivityPEhas_pebupivacaine
MEDRTN0000008768Decreased Organized Electrical ActivityPEhas_pebupivacaine hydrochloride
MEDRTN0000175976Local AnesthesiaPEhas_pebupivacaine hydrochloride
MEDRTN0000175976Local AnesthesiaPEhas_pebupivacaine

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH2.5 MG/ML
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESNDANDA018304
NAMESPrescribable SynonymSensorcaine 0.25 % Injectable Solution
NAMESTallman SynonymBUPivacaine hydrochloride 2.5 MG/ML Injectable Solution [Sensorcaine]
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon