Ibuprofen Lysine
These highlights do not include all the information needed to use IBUPROFEN LYSINE INJECTION safely and effectively. See full prescribing information for IBUPROFEN LYSINE INJECTION. IBUPROFEN LYSINE Injection, for intravenous use Initial U.S. Approval: 2006
Approved
Approval ID
6cfdec66-9483-4abe-98d3-3a7d389cc952
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 1, 2024
Manufacturers
FDA
XGen Pharmaceuticals DJB, Inc.
DUNS: 117380305
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ibuprofen Lysine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code39822-1030
Application NumberANDA202402
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ibuprofen Lysine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 1, 2024
FDA Product Classification
INGREDIENTS (2)
IBUPROFEN LYSINEActive
Quantity: 10 mg in 1 mL
Code: N01ORX9D6S
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT