Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
childrens ibuprofen 100
Product Details
NDC Product Code
0363-1521Application Number
ANDA076359Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 7, 2025IbuprofenActive
Code: WK2XYI10QMClass: ACTIBQuantity: 100 mg in 1 1
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9Class: IACT
AMMONIUM GLYCYRRHIZATEInactive
Code: 3VRD35U26CClass: IACT
ASPARTAMEInactive
Code: Z0H242BBR1Class: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6KClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SOYBEAN OILInactive
Code: 241ATL177AClass: IACT
SUCCINIC ACIDInactive
Code: AB6MNQ6J6LClass: IACT