Ibuprofen
Ibuprofen Oral Suspension USP Rx Only
Approved
Approval ID
758eeb45-e599-4c1a-969d-8fa33f27bf14
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 15, 2023
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ibuprofen Oral
PRODUCT DETAILS
NDC Product Code59651-032
Application NumberANDA209178
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJuly 15, 2023
Generic NameIbuprofen Oral
INGREDIENTS (14)
IBUPROFENActive
Quantity: 100 mg in 5 mL
Code: WK2XYI10QM
Classification: ACTIB
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
RASPBERRYInactive
Code: 4N14V5R27W
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57T
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
STARCH, POTATOInactive
Code: 8I089SAH3T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT