POSIMIR
These highlights do not include all the information needed to use POSIMIR safely and effectively. See full prescribing information for POSIMIR. POSIMIR (bupivacaine solution) for infiltration use Initial U.S. Approval: 1972
Approved
Approval ID
dbc4df8d-62ba-4893-9c0c-90cbc4c4ca39
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 12, 2022
Manufacturers
FDA
INNOCOLL PHARMACEUTICALS
DUNS: 989921395
Products 1
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 Code51715-660
Application NumberNDA204803
Product Classification
M
Marketing Category
C73594
G
Generic Name
bupivacaine
Product Specifications
Route of AdministrationINFILTRATION
Effective DateDecember 12, 2022
FDA Product Classification
INGREDIENTS (3)
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SUCROSE ACETATE ISOBUTYRATEInactive
Code: H5KI1C3YTV
Classification: IACT
BUPIVACAINEActive
Quantity: 660 mg in 5 mL
Code: Y8335394RO
Classification: ACTIB