NDC Code(s) : 69189-0302-1
Packager : Avera McKennan Hospital

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Hydroxyzine PamoateHydroxyzine Pamoate CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69189-0302(NDC:0555-0302)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROXYZINE PAMOATE(UNII: M20215MUFR)
(HYDROXYZINE - UNII:30S50YM8OG) 		HYDROXYZINE50 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
D&C RED NO. 33(UNII: 9DBA0SBB0L)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ALUMINUM OXIDE(UNII: LMI26O6933)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
INDIGOTINDISULFONATE SODIUM(UNII: D3741U8K7L)
FD&C RED NO. 40(UNII: WZB9127XOA)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color YELLOW (light yellow), RED (maroon) Score no score
Shape CAPSULE Size 16 mm
Flavor Imprint Code barr;302;50
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69189-0302-11 in 1 DOSE PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088487 03/04/2015

PRINCIPAL DISPLAY PANEL

Hydroxyzine Pamoate 50mg capsule label