HYDROXYZINE HYDROCHLORIDE
HydrOXYzine Hydrochloride Tablets USP Revised: June 2009 Rx only 190944
Approved
Approval ID
eb509c97-5315-4f69-abb9-c84e1ea63527
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 15, 2011
Manufacturers
FDA
RedPharm Drug Inc.
DUNS: 008039641
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 Code67296-0381
Application NumberANDA088349
Product Classification
M
Marketing Category
C73584
G
Generic Name
HYDROXYZINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJuly 15, 2011
FDA Product Classification
INGREDIENTS (13)
HYDROXYZINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 76755771U3
Classification: ACTIB
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT