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, caudal, epidural, or retrobulbar useInitial U.S. Approval: 1972
Approved
Approval ID
daec9ee4-b666-485e-a153-4b5e5acc48a1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 2, 2024
Manufacturers
FDA
Meitheal Pharmaceuticals Inc
DUNS: 080548348
Products 6
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 Code71288-721
Application NumberANDA216040
Product Classification
M
Marketing Category
C73584
G
Generic Name
bupivacaine hydrochloride
Product Specifications
Route of AdministrationINFILTRATION, PERINEURAL, INTRACAUDAL, EPIDURAL
Effective DateJuly 21, 2023
FDA Product Classification
INGREDIENTS (5)
BUPIVACAINE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 mL
Code: 7TQO7W3VT8
Classification: ACTIR
SODIUM CHLORIDEInactive
Quantity: 8.6 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
bupivacaine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71288-727
Application NumberANDA216040
Product Classification
M
Marketing Category
C73584
G
Generic Name
bupivacaine hydrochloride
Product Specifications
Route of AdministrationEPIDURAL, RETROBULBAR
Effective DateJuly 21, 2023
FDA Product Classification
INGREDIENTS (5)
BUPIVACAINE HYDROCHLORIDEActive
Quantity: 7.5 mg in 1 mL
Code: 7TQO7W3VT8
Classification: ACTIR
SODIUM CHLORIDEInactive
Quantity: 7.6 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
bupivacaine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71288-722
Application NumberANDA216040
Product Classification
M
Marketing Category
C73584
G
Generic Name
bupivacaine hydrochloride
Product Specifications
Route of AdministrationINFILTRATION, PERINEURAL, INTRACAUDAL, EPIDURAL
Effective DateJuly 21, 2023
FDA Product Classification
INGREDIENTS (5)
BUPIVACAINE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 mL
Code: 7TQO7W3VT8
Classification: ACTIR
SODIUM CHLORIDEInactive
Quantity: 8.6 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
bupivacaine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71288-725
Application NumberANDA216040
Product Classification
M
Marketing Category
C73584
G
Generic Name
bupivacaine hydrochloride
Product Specifications
Route of AdministrationPERINEURAL, INTRACAUDAL, EPIDURAL
Effective DateJuly 21, 2023
FDA Product Classification
INGREDIENTS (5)
BUPIVACAINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: 7TQO7W3VT8
Classification: ACTIR
SODIUM CHLORIDEInactive
Quantity: 8.1 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
bupivacaine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71288-724
Application NumberANDA216040
Product Classification
M
Marketing Category
C73584
G
Generic Name
bupivacaine hydrochloride
Product Specifications
Route of AdministrationPERINEURAL, INTRACAUDAL, EPIDURAL
Effective DateJuly 21, 2023
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Quantity: 8.1 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
BUPIVACAINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: 7TQO7W3VT8
Classification: ACTIR
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
bupivacaine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71288-728
Application NumberANDA216040
Product Classification
M
Marketing Category
C73584
G
Generic Name
bupivacaine hydrochloride
Product Specifications
Route of AdministrationEPIDURAL, RETROBULBAR
Effective DateJuly 21, 2023
FDA Product Classification
INGREDIENTS (5)
BUPIVACAINE HYDROCHLORIDEActive
Quantity: 7.5 mg in 1 mL
Code: 7TQO7W3VT8
Classification: ACTIR
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 7.6 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT