Hydroxyzine pamoate capsule

Ingredients and appearance - Product information

Hydroxyzine pamoate capsule- Hydroxyzine pamoate

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0615-0331
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Hydroxyzine pamoate ( UNII: M20215MUFR)( Hydroxyzine - UNII: 30S50YM8OG ) 25 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)
Fd&c green no. 3 ( UNII: 3P3ONR6O1S)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Gelatin ( UNII: 2G86QN327L)
Hydroxypropyl cellulose (type h) ( UNII: RFW2ET671P)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Propylene glycol ( UNII: 6DC9Q167V3)
Sodium lauryl sulfate ( UNII: 368GB5141J)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color GREEN (light green/dark green) Imprint Code E613
Score 1 Shape CAPSULE
Size 19 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA087479 USA

Labeler - NCS HealthCare of KY, Inc dba Vangard Labs( 050052943)

Establishment

Name ID/FEI Business Operations
NCS HealthCare of KY, Inc dba Vangard Labs 050052943 REPACK( 0615-0331)