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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

e700eb7b-8b14-49c9-96b2-331f18776e45

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 12, 2023

Manufacturers
FDA

Fresenius Kabi USA, LLC

DUNS: 608775388

Products 2

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

BUPIVACAINE HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63323-464
Application NumberANDA070552
Product Classification
M
Marketing Category
C73584
G
Generic Name
BUPIVACAINE HYDROCHLORIDE
Product Specifications
Route of AdministrationEPIDURAL, INTRACAUDAL, INFILTRATION, PERINEURAL
Effective DateJuly 12, 2019
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: 2.5 mg in 1 mL
Code: 7TQO7W3VT8
Classification: ACTIR

BUPIVACAINE HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63323-466
Application NumberANDA070553
Product Classification
M
Marketing Category
C73584
G
Generic Name
BUPIVACAINE HYDROCHLORIDE
Product Specifications
Route of AdministrationEPIDURAL, PERINEURAL, INTRACAUDAL
Effective DateJuly 12, 2019
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: 5 mg in 1 mL
Code: 7TQO7W3VT8
Classification: ACTIR

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Sensorcaine - FDA Drug Approval Details