Bupivacaine Hydrochloride
Bupivacaine Hydrochloride Injection
Approved
Approval ID
8c168503-9120-20ea-e053-2a95a90a8bf2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 14, 2021
Manufacturers
FDA
Areva Pharmaceuticals
DUNS: 833189835
Products 4
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 Code59923-720
Product Classification
G
Generic Name
Bupivacaine Hydrochloride
Product Specifications
Route of AdministrationEPIDURAL, INTRACAUDAL, PERINEURAL
Effective DateJanuary 14, 2021
FDA Product Classification
INGREDIENTS (3)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
BUPIVACAINE HYDROCHLORIDE ANHYDROUSActive
Quantity: 5 mg in 1 mL
Code: AKA908P8J1
Classification: ACTIB
Bupivacaine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59923-718
Product Classification
G
Generic Name
Bupivacaine Hydrochloride
Product Specifications
Route of AdministrationEPIDURAL, INTRACAUDAL, PERINEURAL
Effective DateJanuary 14, 2021
FDA Product Classification
INGREDIENTS (3)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BUPIVACAINE HYDROCHLORIDE ANHYDROUSActive
Quantity: 5 mg in 1 mL
Code: AKA908P8J1
Classification: ACTIB
Bupivacaine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59923-717
Product Classification
G
Generic Name
Bupivacaine Hydrochloride
Product Specifications
Route of AdministrationEPIDURAL, INTRACAUDAL, PERINEURAL
Effective DateJanuary 14, 2021
FDA Product Classification
INGREDIENTS (3)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BUPIVACAINE HYDROCHLORIDE ANHYDROUSActive
Quantity: 2.5 mg in 1 mL
Code: AKA908P8J1
Classification: ACTIB
Bupivacaine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59923-719
Product Classification
G
Generic Name
Bupivacaine Hydrochloride
Product Specifications
Route of AdministrationEPIDURAL, INTRACAUDAL, PERINEURAL
Effective DateJanuary 14, 2021
FDA Product Classification
INGREDIENTS (3)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
BUPIVACAINE HYDROCHLORIDE ANHYDROUSActive
Quantity: 2.5 mg in 1 mL
Code: AKA908P8J1
Classification: ACTIB