HYDROXYZINE PAMOATE
Rx only
Approved
Approval ID
29130fb6-7920-4cea-af10-7d23029a7140
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 21, 2014
Manufacturers
FDA
TYA Pharmaceuticals
DUNS: 938389038
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
HYDROXYZINE PAMOATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64725-0169
Application NumberANDA201507
Product Classification
M
Marketing Category
C73584
G
Generic Name
HYDROXYZINE PAMOATE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 20, 2014
FDA Product Classification
INGREDIENTS (10)
HYDROXYZINE PAMOATEActive
Quantity: 25 mg in 1 1
Code: M20215MUFR
Classification: ACTIR
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
HYDROXYZINE PAMOATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64725-0170
Application NumberANDA201507
Product Classification
M
Marketing Category
C73584
G
Generic Name
HYDROXYZINE PAMOATE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 20, 2014
FDA Product Classification
INGREDIENTS (10)
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
HYDROXYZINE PAMOATEActive
Quantity: 50 mg in 1 1
Code: M20215MUFR
Classification: ACTIR
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT