NDC Code(s) : 68084-784-11, 68084-784-21
Packager : American Health Packaging

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:68084-784(NDC:51672-4042)
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 DIPOTASSIUM3.75 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM OXIDE(UNII: 3A3U0GI71G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POTASSIUM CARBONATE(UNII: BQN1B9B9HA)
POTASSIUM CHLORIDE(UNII: 660YQ98I10)
TALC(UNII: 7SEV7J4R1U)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color purple (pale violet) Score 2 pieces
Shape ROUND (flat beveled edge, slightly mottled) Size 9 mm
Flavor Imprint Code T;45
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68084-784-2130 in 1 BOX, UNIT-DOSE 11/08/2014
1NDC:68084-784-111 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075731 07/31/2014 05/31/2017

PRINCIPAL DISPLAY PANEL

Clorazepate Dipotassium Tablets USP, 3.75 mg label

NDC 68084-784-21

Clorazepate
Dipotassium CIV
Tablets USP

3.75 mg

30 Tablets (3 x 10)

DISPENSE WITH THE ACCOMPANYING MEDICATION GUIDE TO EACH PATIENT.

Each tablet contains: 3.75 mg of clorazepate dipotassium USP.

Usual dosage: See package insert for full prescribing information.

Store at 20° to 25°C (68° to 77°F)
[see USP Controlled Room temperature]
Protect from moisture.

Keep this and all drugs out of reach of children.

Rx Only

The drug product contained in this package is from NDC # 51672-4042, Taro Pharmaceuticals U.S.A., Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

078421
Rev. 05/2014