Ibuprofen
Ibuprofen Oral Suspension USP, 100 mg/5 mL
Approved
Approval ID
b3efef0a-1530-6db4-e053-2a95a90aad95
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 13, 2021
Manufacturers
FDA
Pharmaceutical Associates, Inc.
DUNS: 044940096
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 Code0121-0918
Application NumberANDA209204
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateDecember 13, 2021
FDA Product Classification
INGREDIENTS (9)
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
IBUPROFENActive
Quantity: 100 mg in 5 mL
Code: WK2XYI10QM
Classification: ACTIB