hydroxyzine pamoate
Rx only
Approved
Approval ID
74bf62c3-b444-46dc-aab6-af74b101a68a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 28, 2025
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-7540
Application NumberANDA201507
Product Classification
M
Marketing Category
C73584
G
Generic Name
hydroxyzine pamoate
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2025
FDA Product Classification
INGREDIENTS (17)
ACID YELLOW 3Inactive
Code: 35SW5USQ3G
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
HYDROXYZINE PAMOATEActive
Quantity: 50 mg in 1 1
Code: M20215MUFR
Classification: ACTIR
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CURRY REDInactive
Code: WZB9127XOA
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
BLUE 1Inactive
Code: H3R47K3TBD
Classification: IACT
CI 77891Inactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
CI 77499Inactive
Code: XM0M87F357
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT