HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE TABLETS, USP
Approved
Approval ID
beefb4ba-ee88-4923-96b0-72050466847b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2012
Manufacturers
FDA
Life Line Home Care Services, Inc.
DUNS: 844985374
Products 1
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 Code75921-011
Application NumberANDA040787
Product Classification
M
Marketing Category
C73584
G
Generic Name
HYDROXYZINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 18, 2012
FDA Product Classification
INGREDIENTS (11)
HYDROXYZINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 76755771U3
Classification: ACTIB
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT