NEOPROFEN
These highlights do not include all the information needed to use NEOPROFEN safely and effectively. See full prescribing information for NEOPROFEN. NEOPROFEN (ibuprofen lysine) Injection, for intravenous use Initial U.S. Approval: 1974
Approved
Approval ID
6f5ede6f-b0b7-4fc8-969e-652f60ead047
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 2, 2023
Manufacturers
FDA
Recordati Rare Diseases Inc.
DUNS: 181699406
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 Code55292-122
Application NumberNDA021903
Product Classification
M
Marketing Category
C73594
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