HYDROXYZINE PAMOATE
Hydroxyzine Pamoate Capsules USP
Approved
Approval ID
b6a5fb1e-b133-452d-ba97-84c1cca03fc1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 3, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
HYDROXYZINE PAMOATE
PRODUCT DETAILS
NDC Product Code16590-357
Application NumberANDA087479
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 3, 2012
Generic NameHYDROXYZINE PAMOATE
INGREDIENTS (13)
HYDROXYZINE PAMOATEActive
Quantity: 25 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 GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT