EXPAREL
These highlights do not include all the information needed to use EXPAREL® safely and effectively. See full prescribing information for EXPAREL. EXPAREL (bupivacaine liposome injectable suspension), for infiltration or perineural use Initial U.S. Approval: 1972
Approved
Approval ID
bb5a9e59-0f51-11df-8a39-0800200c9a66
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2023
Manufacturers
FDA
Pacira Pharmaceuticals, Inc.
DUNS: 783298615
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
bupivacaine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65250-266
Application NumberNDA022496
Product Classification
M
Marketing Category
C73594
G
Generic Name
bupivacaine
Product Specifications
Route of AdministrationINFILTRATION
Effective DateNovember 30, 2023
FDA Product Classification
INGREDIENTS (1)
BUPIVACAINEActive
Quantity: 13.3 mg in 1 mL
Code: Y8335394RO
Classification: ACTIB
bupivacaine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65250-133
Application NumberNDA022496
Product Classification
M
Marketing Category
C73594
G
Generic Name
bupivacaine
Product Specifications
Route of AdministrationINFILTRATION
Effective DateNovember 30, 2023
FDA Product Classification
INGREDIENTS (1)
BUPIVACAINEActive
Quantity: 13.3 mg in 1 mL
Code: Y8335394RO
Classification: ACTIB