HYDROXYZINE HYDROCHLORIDE
Hydroxyzine HydrochlorideTablets USP Rx only
Approved
Approval ID
178e8ff8-5443-419e-95c5-3eb68817ff66
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 24, 2023
Manufacturers
FDA
Graviti Pharmaceuticals Private Limited
DUNS: 650884781
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69844-072
Application NumberANDA217652
Product Classification
M
Marketing Category
C73584
G
Generic Name
hydroxyzine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 24, 2023
FDA Product Classification
INGREDIENTS (15)
HYDROXYZINE DIHYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 76755771U3
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
HYPROMELLOSE 2910 (50 MPA.S)Inactive
Code: 1IVH67816N
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
hydroxyzine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69844-071
Application NumberANDA217652
Product Classification
M
Marketing Category
C73584
G
Generic Name
hydroxyzine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 24, 2023
FDA Product Classification
INGREDIENTS (15)
HYDROXYZINE DIHYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 76755771U3
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
HYPROMELLOSE 2910 (50 MPA.S)Inactive
Code: 1IVH67816N
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
hydroxyzine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69844-073
Application NumberANDA217652
Product Classification
M
Marketing Category
C73584
G
Generic Name
hydroxyzine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 24, 2023
FDA Product Classification
INGREDIENTS (15)
HYDROXYZINE DIHYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 76755771U3
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
HYPROMELLOSE 2910 (50 MPA.S)Inactive
Code: 1IVH67816N
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT