Hydroxyzine
HYDROXYZINE HYDROCHLORIDETABLETS USP
Approved
Approval ID
a49c7e1a-ed02-439a-9b02-bef7d86ed464
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 6, 2010
Manufacturers
FDA
Blenheim Pharmacal, Inc.
DUNS: 171434587
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydroxyzine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10544-209
Application NumberANDA088617
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydroxyzine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 6, 2010
FDA Product Classification
INGREDIENTS (13)
HYDROXYZINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 76755771U3
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 10/6/2010
307
308
309
Rx only
Iss. 6/2010
11001687