MedPath
FDA Approval

Hydroxyzine Hydrochloride

January 15, 2024

HUMAN PRESCRIPTION DRUG LABEL

Hydroxyzine(50 mg in 1 1)

Products (1)

Hydroxyzine Hydrochloride

70518-3574

ANDA040604

ANDA (C73584)

ORAL

January 15, 2024

MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
Code: 76755771U3Class: ACTIBQuantity: 50 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
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