FDA.reportPublic FDA data

30 ML bupivacaine hydrochloride 5 MG/ML Injection [Sensorcaine]

RxCUI
1724885
RxNorm name
30 ML bupivacaine hydrochloride 5 MG/ML Injection [Sensorcaine]
Display name
SENSORCAINE (Injectable)
Full name
30 ML bupivacaine hydrochloride 5 MG/ML Injection [Sensorcaine]
Term type
SBD
Status
Active
Strength
5 mg/ml
Dose form
Injection 30 ml
Route
Injectable
Updated
2026-10-27 17:49:20

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 hydrochloride5 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 5 MG/ML Injection1NAMES
RxNorm Name30 ML bupivacaine hydrochloride 5 MG/ML Injection [Sensorcaine]1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID
3 linked values
3CODES
RxCUI17248851CODES
MMSL_CODEMTH_RXN_BD149351CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
63323-466-3163323-466SENSORCAINE BUPIVACAINE HYDROCHLORIDEFresenius Kabi USA, LLCNDA018304
63323-466-3763323-466SENSORCAINE BUPIVACAINE HYDROCHLORIDEFresenius Kabi USA, LLCNDA018304
63323-466-3963323-466SENSORCAINE BUPIVACAINE HYDROCHLORIDEFresenius Kabi USA, LLCNDA018304

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA01830463323-466SENSORCAINE 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
00186103391rxnav_ndcsyes
63323046601rxnav_ndcsyes
63323046602rxnav_ndcsyes
63323046609rxnav_ndcsyes
63323046631rxnav_ndcsyes
63323046637rxnav_ndcsyes
63323046639rxnav_ndcsyes
00186103302rxnav_historical
63323046633rxnav_historical
70518139200rxnav_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): 63323-466
rxcui: 1724885
SENSORCAINE MPFBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCeb6d8fee-def4-4c96-9972-695e8cea8ea82024-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 63323-466-31
ndc (package): 63323-466-37
ndc (product): 63323-466
ndc11 (package): 63323046631
ndc11 (package): 63323046637
ndc11 (package): 63323046601
ndc11 (package): 63323046602
rxcui: 1724885
Sensorcaine MPFBUPIVACAINE HYDROCHLORIDEFresenius Kabi USA, LLCe700eb7b-8b14-49c9-96b2-331f18776e452023-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 63323-466
SENSORCAINE MPFBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCdcf3c0ad-9eb8-4ee7-96df-d0db7ff231752022-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 63323-466-39
ndc (product): 63323-466
ndc11 (package): 63323046639
ndc11 (package): 63323046609
rxcui: 1724885

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 0.5 % in 30 ML Injection [PSN] · 30 ML bupivacaine hydrochloride 5 MG/ML Injection [Sensorcaine] [SBD] · 30 ML Sensorcaine 5 MG/ML Injection [SY] · Sensorcaine-MPF 0.5 % 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 0.5 % in 30 ML Injection [PSN] · 30 ML bupivacaine hydrochloride 5 MG/ML Injection [Sensorcaine] [SBD] · 30 ML Sensorcaine 5 MG/ML Injection [SY] · Sensorcaine-MPF 0.5 % 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 0.5 % in 30 ML Injection [PSN] · 30 ML bupivacaine hydrochloride 5 MG/ML Injection [Sensorcaine] [SBD] · 30 ML Sensorcaine 5 MG/ML Injection [SY] · Sensorcaine-MPF 0.5 % 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
2fc4a3a8-ed84-4067-8ba4-d9644f510920REMEDYREPACK INC.20180905
657ee831-9b81-4c3c-b20a-750f968b10a4National Council for Prescription Drug Programs20130213
2e9c4ef2-9963-4c5b-b421-6eb6b197b90bNational Council for Prescription Drug Programs20120724
3651dbee-f4cf-4a36-9e06-cdaa41a82a67National Council for Prescription Drug Programs20120724
40ff32ca-58f3-4498-9e84-01b7728bb04bNational 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_STRENGTH5 MG/ML
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESQUANTITY30 ML
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA070553
CODESNDANDA018304
NAMESPrescribable SynonymSensorcaine 0.5 % in 30 ML Injection
NAMESTallman Synonym30 ML BUPivacaine hydrochloride 5 MG/ML Injection [Sensorcaine]
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon