XARACOLL
These highlights do not include all the information needed to use XARACOLL safely and effectively. See full prescribing information for XARACOLL. XARACOLL (bupivacaine hydrochloride) implantInitial U.S. Approval: 1972
Approved
Approval ID
46da5733-c892-43a5-b826-1898a753f1c3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 8, 2020
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 HCl Collagen-matrix
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51715-100
Application NumberNDA209511
Product Classification
M
Marketing Category
C73594
G
Generic Name
Bupivacaine HCl Collagen-matrix
Product Specifications
Route of AdministrationParenteral
Effective DateSeptember 9, 2020
FDA Product Classification
INGREDIENTS (1)
BUPIVACAINEActive
Quantity: 100 mg in 1 1
Code: Y8335394RO
Classification: ACTIB