Ibuprofen
IBU Tablets
Approved
Approval ID
72ec2491-924d-460f-9510-62d624d54b59
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 12, 2023
Manufacturers
FDA
Preferred Pharmaceuticals, Inc.
DUNS: 791119022
Products 3
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 Code68788-9112
Application NumberANDA075682
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateJuly 12, 2023
FDA Product Classification
INGREDIENTS (11)
IbuprofenActive
Quantity: 800 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB
carnauba waxInactive
Code: R12CBM0EIZ
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
polydextroseInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Ibuprofen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68788-9111
Application NumberANDA075682
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateJuly 12, 2023
FDA Product Classification
INGREDIENTS (11)
IbuprofenActive
Quantity: 600 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB
carnauba waxInactive
Code: R12CBM0EIZ
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
polydextroseInactive
Code: VH2XOU12IE
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Ibuprofen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68788-9110
Application NumberANDA075682
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateJuly 12, 2023
FDA Product Classification
INGREDIENTS (11)
carnauba waxInactive
Code: R12CBM0EIZ
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
IbuprofenActive
Quantity: 400 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
polydextroseInactive
Code: VH2XOU12IE
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT