SPL Set ID: f2bf6742-4b85-45e2-8daa-0f9bfc75a128
1 drug(s) with this SPL Set ID
Acamprosate calcium is supplied in 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 3-(Acetylamino)-1-propanesulfonic acid calcium salt (2:1). Its chemical formula is C 10 H 20 N 2 O 8 S 2 Ca and molecular weight is 400.48. Its structural formula is: Acamprosate calcium, USP is a white odorless crystalline powder. It is freely soluble in water, and practically insoluble in absolute ethanol and dichloromethane. Each acamprosate calcium delayed-release tablet contains acamprosate calcium 333 mg, equivalent to 300 mg of acamprosate. Inactive ingredients in acamprosate calcium delayed-release tablets include: colloidal silicon dioxide, glyceryl dibehenate, hypromellose, magnesium stearate, methacrylic acid copolymer type A, microcrystalline cellulose, propylene glycol 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. Acamprosate Calcium Structural Formula