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FDA Approval

ibuprofen

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
April 27, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Ibuprofen(100 mg in 5 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ibuprofen childrens

Product Details

NDC Product Code
41250-897
Application Number
ANDA074937
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 27, 2025
IbuprofenActive
Code: WK2XYI10QMClass: ACTIBQuantity: 100 mg in 5 mL
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
HIGH FRUCTOSE CORN SYRUPInactive
Code: XY6UN3QB6SClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
SORBITOL SOLUTIONInactive
Code: 8KW3E207O2Class: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
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