Sensorcaine
451106H /Revised: March 2019SensorcaineSensorcaine -MPFRx only Sensorcaine (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)
Approved
Approval ID
07800675-f689-47d7-8203-073c797f7e21
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2022
Manufacturers
FDA
General Injectables & Vaccines, Inc
DUNS: 108250663
Products 1
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 Code52584-467
Application NumberNDA018304
Product Classification
M
Marketing Category
C73594
G
Generic Name
Bupivacaine Hydrochloride
Product Specifications
Route of AdministrationPERINEURAL
Effective DateDecember 29, 2022
FDA Product Classification
INGREDIENTS (5)
BUPIVACAINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: 7TQO7W3VT8
Classification: ACTIR
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
METHYLPARABENInactive
Quantity: 1 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT