Bupivacaine hydrochloride
These highlights do not include all the information needed to use BUPIVACAINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for BUPIVACAINE HYDROCHLORIDE INJECTION.BUPIVACAINE HYDROCHLORIDE injection, for infiltration, perineural, or retrobulbar use Initial U.S. Approval:1972
Approved
Approval ID
bcaab86f-20f0-4482-8d73-e29b36dced58
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 19, 2023
Manufacturers
FDA
Somerset Therapeutics, LLC
DUNS: 079947873
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 Code70069-752
Application NumberANDA217792
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bupivacaine hydrochloride
Product Specifications
Route of AdministrationINFILTRATION, PERINEURAL
Effective DateSeptember 19, 2023
FDA Product Classification
INGREDIENTS (5)
BUPIVACAINE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 mL
Code: 7TQO7W3VT8
Classification: ACTIR
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Bupivacaine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70069-753
Application NumberANDA217792
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bupivacaine hydrochloride
Product Specifications
Route of AdministrationINFILTRATION, PERINEURAL
Effective DateSeptember 19, 2023
FDA Product Classification
INGREDIENTS (5)
BUPIVACAINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: 7TQO7W3VT8
Classification: ACTIR
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT