NDC Code(s) : 43063-095-06, 43063-095-10, 43063-095-12, 43063-095-16, 43063-095-20, 43063-095-40, 43063-095-60
Packager : PD-Rx Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Hydroxyzine HydrochlorideHydroxyzine TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-095(NDC:67405-671)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROXYZINE HYDROCHLORIDE(UNII: 76755771U3)
(HYDROXYZINE - UNII:30S50YM8OG) 		HYDROXYZINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
CARNAUBA WAX(UNII: R12CBM0EIZ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (12 MPA.S AT 5%)(UNII: 40UAA97IT9)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color white Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code AN;71
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43063-095-066 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product16/04/2009
2NDC:43063-095-1010 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product16/04/2009
3NDC:43063-095-1212 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product04/08/2013
4NDC:43063-095-1616 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product04/08/2013
5NDC:43063-095-2020 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product23/01/2013
6NDC:43063-095-4040 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product16/10/2013
7NDC:43063-095-6060 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product16/10/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040808 06/29/2007

PRINCIPAL DISPLAY PANEL

image