Ibuprofen

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

42291-442

Application Number

ANDA078329

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

June 1, 2021

Ingredients

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

Code: WK2XYI10QMClass: ACTIBQuantity: 800 mg in 1 1

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SODIUM CITRATEInactive

Code: 1Q73Q2JULRClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT