hydroxyzine pamoate
Hydroxyzine Pamoate Capsules USP
Approved
Approval ID
ba04ac99-6321-4431-97e1-e18083d7b137
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 25, 2013
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-1854
Application NumberANDA086183
Product Classification
M
Marketing Category
C73584
G
Generic Name
hydroxyzine pamoate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 25, 2013
FDA Product Classification
INGREDIENTS (13)
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYZINE PAMOATEActive
Quantity: 50 mg in 1 1
Code: M20215MUFR
Classification: ACTIR
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
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 Code54868-2892
Application NumberANDA087479
Product Classification
M
Marketing Category
C73584
G
Generic Name
hydroxyzine pamoate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 25, 2013
FDA Product Classification
INGREDIENTS (13)
HYDROXYZINE PAMOATEActive
Quantity: 25 mg in 1 1
Code: M20215MUFR
Classification: ACTIR
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT