MedPath

SENSORCAINE

These 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 useSENSORCAINE-MPF WITH EPINEPHRINE (bupivacaine hydrochloride and epinephrine) injection, for infiltration, perineural, caudal, epidural, or retrobulbar useSENSORCAINE (bupivacaine hydrochloride) injection, for infiltration, perineural useSENSORCAINE WITH EPINEPHRINE (bupivacaine hydrochloride and epinephrine) injection, for infiltration, perineural useInitial U.S. Approval: 1972

Approved
Approval ID

bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 30, 2023

Manufacturers
FDA

Fresenius Kabi USA, LLC

DUNS: 608775388

Products 4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63323-468
Application NumberANDA070966
Product Classification
M
Marketing Category
C73584
G
Generic Name
BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE
Product Specifications
Route of AdministrationINFILTRATION, EPIDURAL, INTRACAUDAL, PERINEURAL
Effective DateApril 30, 2023
FDA Product Classification

INGREDIENTS (7)

CITRIC ACID MONOHYDRATEInactive
Quantity: 0.2 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
SODIUM METABISULFITEInactive
Quantity: 0.5 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
BUPIVACAINE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 mL
Code: 7TQO7W3VT8
Classification: ACTIR
EPINEPHRINE BITARTRATEActive
Quantity: 0.005 mg in 1 mL
Code: 30Q7KI53AK
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63323-461
Application NumberANDA070967
Product Classification
M
Marketing Category
C73584
G
Generic Name
BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE
Product Specifications
Route of AdministrationINFILTRATION, PERINEURAL
Effective DateApril 30, 2023
FDA Product Classification

INGREDIENTS (8)

CITRIC ACID MONOHYDRATEInactive
Quantity: 0.2 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
SODIUM METABISULFITEInactive
Quantity: 0.5 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
METHYLPARABENInactive
Quantity: 1 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
BUPIVACAINE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 mL
Code: 7TQO7W3VT8
Classification: ACTIR
EPINEPHRINE BITARTRATEActive
Quantity: 0.005 mg in 1 mL
Code: 30Q7KI53AK
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63323-463
Application NumberANDA070968
Product Classification
M
Marketing Category
C73584
G
Generic Name
BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE
Product Specifications
Route of AdministrationPERINEURAL
Effective DateApril 30, 2023
FDA Product Classification

INGREDIENTS (8)

CITRIC ACID MONOHYDRATEInactive
Quantity: 0.2 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
SODIUM METABISULFITEInactive
Quantity: 0.5 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
METHYLPARABENInactive
Quantity: 1 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
EPINEPHRINE BITARTRATEActive
Quantity: 0.005 mg in 1 mL
Code: 30Q7KI53AK
Classification: ACTIM
BUPIVACAINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: 7TQO7W3VT8
Classification: ACTIR

BUPIVACAINE HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63323-472
Application NumberANDA070554
Product Classification
M
Marketing Category
C73584
G
Generic Name
BUPIVACAINE HYDROCHLORIDE
Product Specifications
Route of AdministrationEPIDURAL, RETROBULBAR
Effective DateApril 30, 2023
FDA Product Classification

INGREDIENTS (4)

SODIUM CHLORIDEInactive
Quantity: 8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
BUPIVACAINE HYDROCHLORIDEActive
Quantity: 7.5 mg in 1 mL
Code: 7TQO7W3VT8
Classification: ACTIR

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

SENSORCAINE - FDA Drug Approval Details