HydrOXYzine hydrochloride
Approved
Approval ID
81f9d88f-c50b-4c6a-a25b-46fa162a503e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 4, 2010
Manufacturers
FDA
Caraco Pharmaceutical Laboratories, Ltd.
DUNS: 146974886
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 Code57664-112
Application NumberANDA040899
Product Classification
M
Marketing Category
C73584
G
Generic Name
HydrOXYzine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 4, 2010
FDA Product Classification
INGREDIENTS (11)
HYDROXYZINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 76755771U3
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HydrOXYzine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57664-113
Application NumberANDA040899
Product Classification
M
Marketing Category
C73584
G
Generic Name
HydrOXYzine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 4, 2010
FDA Product Classification
INGREDIENTS (11)
HYDROXYZINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 76755771U3
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HydrOXYzine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57664-114
Application NumberANDA040899
Product Classification
M
Marketing Category
C73584
G
Generic Name
HydrOXYzine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 4, 2010
FDA Product Classification
INGREDIENTS (11)
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYDROXYZINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 76755771U3
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT