FDA.reportPublic FDA data

30 ML bupivacaine hydrochloride 2.5 MG/ML Injection [Sensorcaine]

RxCUI
1725177
RxNorm name
30 ML bupivacaine hydrochloride 2.5 MG/ML Injection [Sensorcaine]
Display name
SENSORCAINE (Injectable)
Full name
30 ML bupivacaine hydrochloride 2.5 MG/ML Injection [Sensorcaine]
Term type
SBD
Status
Active
Strength
2.5 mg/ml
Dose form
Injection 30 ml
Route
Injectable
Updated
2026-10-27 17:49:36

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
012016
Active start
012016
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
Injection1649574

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
bupivacaine1815

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STR30 ML Sensorcaine 2.5 MG/ML Injection1NAMES
RxNorm Name30 ML bupivacaine hydrochloride 2.5 MG/ML Injection [Sensorcaine]1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID
3 linked values
3CODES
RxCUI17251771CODES
MMSL_CODEMTH_RXN_BD149341CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
63323-464-3163323-464SENSORCAINE BUPIVACAINE HYDROCHLORIDEFresenius Kabi USA, LLCNDA018304
63323-464-3763323-464SENSORCAINE BUPIVACAINE HYDROCHLORIDEFresenius Kabi USA, LLCNDA018304
63323-464-3963323-464SENSORCAINE BUPIVACAINE HYDROCHLORIDEFresenius Kabi USA, LLCNDA018304

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA01830463323-464SENSORCAINE BUPIVACAINE HYDROCHLORIDENDAFresenius Kabi USA, LLC

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 10 matching rows.

NDC11, Source, Active table
NDC11SourceActive
63323046402rxnav_ndcsyes
63323046403rxnav_ndcsyes
63323046409rxnav_ndcsyes
63323046431rxnav_ndcsyes
63323046437rxnav_ndcsyes
63323046439rxnav_ndcsyes
00186103001rxnav_historical
00186103002rxnav_historical
00186103091rxnav_historical
63323046433rxnav_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
SENSORCAINE MPFBUPIVACAINE HYDROCHLORIDEFresenius Kabi USA, LLCb6bfc04a-1868-4630-9ca1-8c027af97ce32024-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 63323-464
rxcui: 1725177
SENSORCAINE MPFBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCeb6d8fee-def4-4c96-9972-695e8cea8ea82024-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 63323-464-37
ndc (package): 63323-464-31
ndc (product): 63323-464
ndc11 (package): 63323046402
ndc11 (package): 63323046431
ndc11 (package): 63323046403
ndc11 (package): 63323046437
rxcui: 1725177
Sensorcaine MPFBUPIVACAINE HYDROCHLORIDEFresenius Kabi USA, LLCe700eb7b-8b14-49c9-96b2-331f18776e452023-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 63323-464
SENSORCAINE MPFBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCdcf3c0ad-9eb8-4ee7-96df-d0db7ff231752022-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 63323-464-39
ndc (product): 63323-464
ndc11 (package): 63323046439
ndc11 (package): 63323046409
rxcui: 1725177

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
eb6d8fee-def4-4c96-9972-695e8cea8ea8Sensorcaine 0.25 % in 30 ML Injection [PSN] · 30 ML bupivacaine hydrochloride 2.5 MG/ML Injection [Sensorcaine] [SBD] · 30 ML Sensorcaine 2.5 MG/ML Injection [SY] · Sensorcaine-MPF 0.25 % in 30 ML Injection [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
b6bfc04a-1868-4630-9ca1-8c027af97ce3Sensorcaine 0.25 % in 30 ML Injection [PSN] · 30 ML bupivacaine hydrochloride 2.5 MG/ML Injection [Sensorcaine] [SBD] · 30 ML Sensorcaine 2.5 MG/ML Injection [SY] · Sensorcaine-MPF 0.25 % in 30 ML Injection [SY]41Sensorcaine ® -MPF (bupivacaine HCl Injection, USP) Sensorcaine ® -MPF with Epinephrine (bupivacaine HCl and epinephrine Injection, USP) 1:200,000 (as bitartrate)20241118
dcf3c0ad-9eb8-4ee7-96df-d0db7ff23175Sensorcaine 0.25 % in 30 ML Injection [PSN] · 30 ML bupivacaine hydrochloride 2.5 MG/ML Injection [Sensorcaine] [SBD] · 30 ML Sensorcaine 2.5 MG/ML Injection [SY] · Sensorcaine-MPF 0.25 % in 30 ML Injection [SY]41Sensorcaine ® -MPF (bupivacaine HCl Injection, USP) Sensorcaine ® -MPF with Epinephrine (bupivacaine HCl and epinephrine Injection, USP) 1:200,000 (as bitartrate)20220817

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
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
dcf3c0ad-9eb8-4ee7-96df-d0db7ff23175Sensorcaine ® -MPF (bupivacaine HCl Injection, USP) Sensorcaine ® -MPF with Epinephrine (bupivacaine HCl and epinephrine Injection, USP) 1:200,000 (as bitartrate)Fresenius Kabi USA, LLC20220817
77835e45-e7a7-46f2-888e-7c68cad0a54cNational 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
ATTRIBUTESQUANTITY30 ML
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA070552
CODESNDANDA018304
NAMESPrescribable SynonymSensorcaine 0.25 % in 30 ML Injection
NAMESTallman Synonym30 ML BUPivacaine hydrochloride 2.5 MG/ML Injection [Sensorcaine]
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon