ibuprofen
Ibuprofen Oral Suspension Drug Facts
Approved
Approval ID
02889717-204c-463b-8506-4c5cf18c77d3
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Mar 3, 2025
Manufacturers
FDA
Padagis Israel Pharmaceuticals Ltd
DUNS: 600093611
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ibuprofen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code45802-897
Application NumberANDA074937
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateMarch 3, 2025
FDA Product Classification
INGREDIENTS (12)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
HIGH FRUCTOSE CORN SYRUPInactive
Code: XY6UN3QB6S
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
IBUPROFENActive
Quantity: 100 mg in 5 mL
Code: WK2XYI10QM
Classification: ACTIB
SORBITOL SOLUTIONInactive
Code: 8KW3E207O2
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT