HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
Approved
Approval ID
d60603e7-15c5-7b01-e053-2995a90ad252
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 1, 2023
Manufacturers
FDA
DirectRx
DUNS: 079254320
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72189-315
Application NumberANDA040156
Product Classification
M
Marketing Category
C73584
G
Generic Name
HYDROXYZINE PAMOATE
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2023
FDA Product Classification
INGREDIENTS (10)
HYDROXYZINE PAMOATEActive
Quantity: 50 mg in 1 1
Code: M20215MUFR
Classification: ACTIR
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT