Ibuprofen
Ibuprofen Oral Suspension USP, 100 mg/5 mL
Approved
Approval ID
d40a898e-524a-4f6e-83a7-bab4ce5218d1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 14, 2021
Manufacturers
FDA
PINNACLE PHARMA LLC
DUNS: 081126970
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ibuprofen
PRODUCT DETAILS
NDC Product Code81646-113
Application NumberANDA076925
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 14, 2021
Generic NameIbuprofen
INGREDIENTS (14)
IBUPROFENActive
Quantity: 100 mg in 5 mL
Code: WK2XYI10QM
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
BUTYLPARABENInactive
Code: 3QPI1U3FV8
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
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
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT