SPL Set ID: 24847065-0be0-46eb-a084-7e5425a8be73

Name: Midodrine hydrochloride tablets, USP Dosage Form: 2.5 mg, 5 mg and 10 mg tablets for oral administration Active Ingredient: Midodrine hydrochloride, USP 2.5 mg, 5 mg and 10 mg Inactive Ingredients: colloidal silicon dioxide, corn starch, FD&C Blue No. 1 Lake (10 mg tablets), FD&C Red No. 40 Lake (5 mg and 10 mg tablets), magnesium stearate, microcrystalline cellulose and talc. Pharmacological Classification: Vasopressor/Antihypotensive Chemical Names (USAN: Midodrine Hydrochloride): (1) Acetamide, 2-amino-N-[2-(2,5-dimethoxyphenyl)-2-hydroxyethyl]-monohydrochloride, (±)-; (2) (±)-2-amino- N -(β-hydroxy-2,5-dimethoxyphenethyl)acetamide monohydrochloride BAN, INN, JAN: Midodrine Structural Formula: Molecular Formula: C 12 H 18 N 2 O 4 HCl; Molecular Weight: 290.7 Organoleptic Properties: Odorless, white, crystalline powder Solubility: Water: Soluble Methanol: Sparingly soluble pKa: 7.8 (0.3% aqueous solution) pH: 3.5 to 5.5 (5% aqueous solution) Melting Range: 200° to 203°C chemical structure