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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLORAZEPATE DIPOTASSIUM(UNII: 63FN7G03XY)
(CLORAZEPIC ACID - UNII:D51WO0G0L4) 		CLORAZEPATE DIPOTASSIUM15 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43063-382-033 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product16/08/2012
2NDC:43063-382-066 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product16/08/2012
3NDC:43063-382-1010 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product16/08/2012
4NDC:43063-382-1212 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product16/08/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076911 01/14/2005

PRINCIPAL DISPLAY PANEL


Clorazepate dipotassium tablets, USP, 15 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient *

Rx only


43063382 Label