Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetaminophen and Ibuprofen
Product Details
NDC Product Code
51316-131Application Number
ANDA216592Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 2, 2025POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0WClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
IbuprofenActive
Code: WK2XYI10QMClass: ACTIBQuantity: 125 mg in 1 1
POVIDONE K90Inactive
Code: RDH86HJV5ZClass: IACT
AcetaminophenActive
Code: 362O9ITL9DClass: ACTIBQuantity: 250 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT