ZOLOFT (sertraline) Pharmaceutical Information

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Drug Substance

Tradename: ZOLOFT
Generic Name: sertraline hydrochloride
Code Name: CP-51,974-01
Chemical Name: (lS,cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride
Structural Formula:
Molecular Formula: C17H17NCl2HCl
Molecular Weight: 342.7
Description: Sertraline hydrochloride is a white to off-white crystalline powder that is slightly soluble in water and isopropyl alcohol, very slightly soluble in 0.1N aqueous hydrochloric acid, practically insoluble in 0.1N aqueous sodium hydroxide, sparingly soluble in ethanol, and soluble in chloroform.

Capsules are formulated to contain sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline.

The following excipients are used in the manufacture of ZOLOFT capsules:

Lactose, anhydrous
Corn Starch
Magnesium Stearate
Sodium Lauryl Sulfate
Hard Gelatin Capsule Shells