Hydroxyzine Pamoate
HYDROXYZINE PAMOATE Capsules USP
Approved
Approval ID
740fad03-94a7-4da6-86e2-a1622d907f27
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 15, 2011
Manufacturers
FDA
RedPharm Drug Inc.
DUNS: 008039641
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 Code67296-0152
Application NumberANDA088496
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydroxyzine Pamoate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 15, 2011
FDA Product Classification
INGREDIENTS (17)
HYDROXYZINE PAMOATEActive
Quantity: 25 mg in 1 1
Code: M20215MUFR
Classification: ACTIR
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 8/9/2006
0323
0302
0324
Iss. 6/2010
11001678
Rx only