SPL Set ID: 4473326f-79f1-61b2-e063-6294a90a17a3
1 drug(s) with this SPL Set ID
Acamprosate calcium delayed-release tablets are supplied as an enteric-coated tablet for oral administration. Acamprosate calcium is a synthetic compound with a chemical structure similar to that of the endogenous amino acid homotaurine, which is a structural analogue of the amino acid neurotransmitter γ-aminobutyric acid and the amino acid neuromodulator taurine. Its chemical name is calcium acetylaminopropane sulfonate. Its chemical formula is C 10 H 20 N 2 O 8 S 2 Ca and molecular weight is 400.48 g/mol. Its structural formula is: Acamprosate calcium, USP is white or almost white powder. It is freely soluble in water, practically insoluble in alcohol and in methylene chloride. Each acamprosate calcium delayed-release tablet contains acamprosate calcium, USP 333 mg, equivalent to 300 mg of acamprosate. Inactive ingredients in acamprosate calcium delayed-release tablets include: colloidal silicon dioxide, crospovidone, magnesium silicate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, povidone, propylene glycol, sodium starch glycolate, and talc. In addition, the black imprinting ink for the tablets contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze. Sulfites were used in the synthesis of the drug substance and traces of residual sulfites may be present in the drug product. Structure.jpg