DEPAKOTE Delayed-release tablet Ref.[10553] 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 tablets are for oral administration. Depakote tablets are supplied in three dosage strengths containing divalproex sodium equivalent to 125 mg, 250 mg, or 500 mg of valproic acid.

Inactive Ingredients

Depakote tablets: cellulosic polymers, diacetylated monoglycerides, povidone, pregelatinized starch (contains corn starch), silica gel, talc, titanium dioxide, and vanillin.

In addition, individual tablets contain:

125 mg tablets: FD&C Blue No. 1 and FD&C Red No. 40.

250 mg tablets: FD&C Yellow No. 6 and iron oxide.

500 mg tablets: D&C Red No. 30, FD&C Blue No. 2, and iron oxide.

Dosage Forms and Strengths

Depakote tablets (divalproex sodium delayed-release tablets) are supplied as:

  • 125 mg salmon pink-colored tablets
  • 250 mg peach-colored tablets
  • 500 mg lavender-colored tablets
How Supplied

Depakote tablets (divalproex sodium delayed-release tablets) are supplied as:

125 mg salmon pink-colored tablets:

Bottles of 100 (NDC 0074-6212-13)
Unit Dose Packages of 100 (NDC 0074-6212-11)

250 mg peach-colored tablets:

Bottles of 100 (NDC 0074-6214-13)
Bottles of 500 (NDC 0074-6214-53)
Unit Dose Packages of 100 (NDC 0074-6214-11)

500 mg lavender-colored tablets:

Bottles of 100 (NDC 0074-6215-13)
Bottles of 500 (NDC 0074-6215-53)
Unit Dose Packages of 100 (NDC 0074-6215-11)

Mfd. by: AbbVie LTD, Barceloneta, PR 00617

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

Drugs

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

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