Hydroxyzine Pamoate
HydrOXYzine Pamoate Capsules, USP Rx only
Approved
Approval ID
2bbcabc3-657f-4b2e-a473-774adfeba78e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 17, 2010
Manufacturers
FDA
Contract Pharmacy Services-PA
DUNS: 945429777
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 Code67046-282
Application NumberANDA086183
Product Classification
M
Marketing Category
C73584
G
Generic Name
HYDROXYZINE PAMOATE
Product Specifications
Route of AdministrationORAL
Effective DateMay 25, 2010
FDA Product Classification
INGREDIENTS (14)
HYDROXYZINE PAMOATEActive
Quantity: 50 mg in 1 1
Code: M20215MUFR
Classification: ACTIR
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYDROXYZINE PAMOATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67046-281
Application NumberANDA087479
Product Classification
M
Marketing Category
C73584
G
Generic Name
HYDROXYZINE PAMOATE
Product Specifications
Route of AdministrationORAL
Effective DateMay 25, 2010
FDA Product Classification
INGREDIENTS (14)
HYDROXYZINE PAMOATEActive
Quantity: 25 mg in 1 1
Code: M20215MUFR
Classification: ACTIR
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT