DEPAKOTE SPRINKLES Capsule Ref.[10555] Active ingredients: Valproic acid

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure:

Divalproex sodium occurs as a white powder with a characteristic odor.

Depakote Sprinkle Capsules are for oral administration. Depakote Sprinkle Capsules contain specially coated particles of divalproex sodium equivalent to 125 mg of valproic acid in a hard gelatin capsule.

Inactive Ingredients:

125 mg Depakote Sprinkle Capsules: cellulosic polymers, D&C Red No. 28, FD&C Blue No. 1 gelatin, iron oxide, magnesium stearate, silica gel, titanium dioxide, and triethyl citrate.

Meets USP Dissolution Test 2.

Dosage Forms and Strengths

Depakote Sprinkle Capsules are for oral administration. Depakote Sprinkle Capsules contain specially coated particles of divalproex sodium equivalent to 125 mg of valproic acid in a hard gelatin capsule.

How Supplied

Depakote Sprinkle Capsules (divalproex sodium delayed release capsules), for oral use 125 mg, are white opaque and blue, and are supplied in bottles of 100 (NDC 0074-6114-13) and Unit Dose Packages of 100 (NDC 0074-6114-11).

AbbVie Inc., North Chicago, IL 60064, U.S.A.

Drugs

Drug Countries
DEPAKOTE Brazil, France, United Kingdom, United States

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