Drug Information for Folic Acid Tablets, (Amneal Pharmaceuticals, LLC): DESCRIPTION

Folic acid, N-[p-[[(2-amino-4- hydroxy-6-pteridinyl) methyl]- amino] benzoyl]-Lglutamic acid, is a B complex vitamin containing apteridine moiety linked by a methylene bridge to para-aminobenzoic acid, which is joined by a peptide linkage to glutamic acid. Conjugates of folic acid are present in a wide variety of foods, particularly liver, kidneys, yeast, and leafy green vegetables. Commercially available folic acid is pre pared synthetically. Folic acid occurs as a yellow or yellowish-orange crystalline powder and is very slightly soluble in water and insoluble in alcohol. Folic acid is readily soluble in dilute solutions of alkali hydroxides and carbonates, and solutions of the drug may be prepared with the aid of sodium hydroxide or sodium carbonate, thereby forming the soluble sodium salt of folic acid (sodium folate). Aqueous solutions of folic acid are heat sensitive and rapidly decompose in the presence of light and/or riboflavin; solutions should be stored in a cool place protected from light.

The structural formula of folic acid is as follows:

C₁₉H₁₉N₇O₆ M.W. 441.40

Each tablet, for oral administration, contains 1 mg folic acid.

Folic Acid Tablets, USP 1 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and stearic acid.