NDC 43063-095-20
API & Excipient Details

Hydroxyzine Dihydrochloride marketed by PD-Rx Pharmaceuticals, Inc. under NDC Code 43063-095-20

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROXYZINE HYDROCHLORIDE(UNII: 76755771U3) (HYDROXYZINE - UNII:30S50YM8OG)	HYDROXYZINE HYDROCHLORIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43063-095-06	6 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product	16/04/2009
2	NDC:43063-095-10	10 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product	16/04/2009
3	NDC:43063-095-12	12 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product	04/08/2013
4	NDC:43063-095-16	16 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product	04/08/2013
5	NDC:43063-095-20	20 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product	23/01/2013
6	NDC:43063-095-40	40 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product	16/10/2013
7	NDC:43063-095-60	60 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product	16/10/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA040808	06/29/2007

PRINCIPAL DISPLAY PANEL