Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Preferred Pharmaceuticals, Inc.
791119022
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Preferred Pharmaceuticals, Inc.
Preferred Pharmaceuticals, Inc.
Preferred Pharmaceuticals, Inc.
791119022
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ibuprofen
Product Details
NDC Product Code
68788-9112Application Number
ANDA075682Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
July 12, 2023IbuprofenActive
Code: WK2XYI10QMClass: ACTIBQuantity: 800 mg in 1 1
carnauba waxInactive
Code: R12CBM0EIZClass: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4Class: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
polydextroseInactive
Code: VH2XOU12IEClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
Ibuprofen
Product Details
NDC Product Code
68788-9111Application Number
ANDA075682Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
July 12, 2023IbuprofenActive
Code: WK2XYI10QMClass: ACTIBQuantity: 600 mg in 1 1
carnauba waxInactive
Code: R12CBM0EIZClass: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4Class: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
polydextroseInactive
Code: VH2XOU12IEClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
Ibuprofen
Product Details
NDC Product Code
68788-9110Application Number
ANDA075682Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
July 12, 2023carnauba waxInactive
Code: R12CBM0EIZClass: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4Class: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
IbuprofenActive
Code: WK2XYI10QMClass: ACTIBQuantity: 400 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
polydextroseInactive
Code: VH2XOU12IEClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT