Ibuprofen Lysine
These highlights do not include all the information needed to use Ibuprofen Lysine safely and effectively. See full prescribing information for Ibuprofen Lysine. Ibuprofen Lysine Injection, for intravenous use Initial U.S. Approval: 1974
Approved
Approval ID
307431c7-12de-21e5-e054-00144ff88e88
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 5, 2024
Manufacturers
FDA
Prasco Laboratories
DUNS: 065969375
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 Code66993-490
Application NumberNDA021903
Product Classification
M
Marketing Category
C73605
G
Generic Name
ibuprofen lysine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 31, 2023
FDA Product Classification
INGREDIENTS (2)
IBUPROFEN LYSINEActive
Quantity: 10 mg in 1 mL
Code: N01ORX9D6S
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT