NDC 43063-382-10
API & Excipient Details

Clorazepate Dipotassium marketed by PD-Rx Pharmaceuticals, Inc. under NDC Code 43063-382-10

NDC Code(s) : 43063-382-03, 43063-382-06, 43063-382-10, 43063-382-12
Packager : PD-Rx Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Clorazepate dipotassiumClorazepate dipotassium TABLET

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:43063-382(NDC:63304-554)
Route of Administration	ORAL	DEA Schedule	CIV

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CLORAZEPATE DIPOTASSIUM(UNII: 63FN7G03XY) (CLORAZEPIC ACID - UNII:D51WO0G0L4)	CLORAZEPATE DIPOTASSIUM	15 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM OXIDE(UNII: 3A3U0GI71G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POTASSIUM CARBONATE(UNII: BQN1B9B9HA)
POTASSIUM CHLORIDE(UNII: 660YQ98I10)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
FD&C RED NO. 40(UNII: WZB9127XOA)

Product Characteristics
Color	red	Score	2 pieces
Shape	ROUND	Size	8 mm
Flavor		Imprint Code	RX;554
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43063-382-03	3 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product	16/08/2012
2	NDC:43063-382-06	6 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product	16/08/2012
3	NDC:43063-382-10	10 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product	16/08/2012
4	NDC:43063-382-12	12 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product	16/08/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076911	01/14/2005

PRINCIPAL DISPLAY PANEL