Hydroxyzine Hydrochloride
Hydroxyzine Hydrochloride Tablets USP, Film-Coated Rx Only
Approved
Approval ID
82b015dc-999c-46a4-bcaa-a4c81a193b68
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2023
Manufacturers
FDA
Epic Pharma, LLC
DUNS: 827915443
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydroxyzine Hydrochloride
PRODUCT DETAILS
NDC Product Code42806-161
Application NumberANDA040604
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 28, 2023
Generic NameHydroxyzine Hydrochloride
INGREDIENTS (16)
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
HYDROXYZINE DIHYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 76755771U3
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Hydroxyzine Hydrochloride
PRODUCT DETAILS
NDC Product Code42806-160
Application NumberANDA040602
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 28, 2023
Generic NameHydroxyzine Hydrochloride
INGREDIENTS (15)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYDROXYZINE DIHYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 76755771U3
Classification: ACTIB
Hydroxyzine Hydrochloride
PRODUCT DETAILS
NDC Product Code42806-159
Application NumberANDA040600
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 28, 2023
Generic NameHydroxyzine Hydrochloride
INGREDIENTS (15)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYDROXYZINE DIHYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 76755771U3
Classification: ACTIB