Minds On Meds

Mental Health Medications

Anti-Anxiety Medications

Clorazepate Dipotassium, Page 2

Clorazepate dipotassium is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. It has depressant effects on the central nervous system. The primary metabolite, nordiazepam, quickly appears in the blood stream. The serum half-life is about 2 days.

Reproduction Studies

Standard fertility, reproduction, and teratology studies were conducted in rats and rabbits. Oral doses in rats up to 150 mg/kg and in rabbits up to 15 mg/kg produced no abnormalities in the fetuses. Clorazepate dipotassium did not alter the fertility indices or reproductive capacity of adult animals. As expected, the sedative effect of high doses interfered with care of the young by their mothers (see Usage in Pregnancy).

HOW SUPPLIED

The 7.5 mg tablets are peach round, scored tablets debossed with M above the score and 40 below the score on one side of the tablet and blank on the other side. They are available as follows:

NDC 67046-906-30
blister of 30 tablets

Recommended storage

Protect from moisture. Keep bottle tightly closed. Store between 20° to 25°C (68° to 70°F) [see USP Controlled Room temperature]. Dispense in a USP tight, light-resistant container.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505

Repackaged by:
Contract Pharmacy Services-PA
125 Titus Ave Suite 200
Warrington, PA 18976 USA

Original–3/2011–NJW

Principal Display Panel

7.5 mg Tablets
(click image for full-size original)

7.5 mg Tablets

CLORAZEPATE DIPOTASSIUM
clorazepate dipotassium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67046-906(NDC:0378-0040)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLORAZEPATE DIPOTASSIUM (CLORAZEPIC ACID) CLORAZEPATE DIPOTASSIUM 7.5 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
FD&C YELLOW NO. 6
MAGNESIUM OXIDE
MAGNESIUM STEARATE
POTASSIUM CARBONATE
SODIUM CHLORIDE
SODIUM LAURYL SULFATE
Product Characteristics
Color ORANGE Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code M;40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67046-906-30 30 TABLET (TABLET) in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071858 03/29/2011
Labeler — Contract Pharmacy Services-PA (945429777)

Revised: 12/2010 Contract Pharmacy Services-PA