SPL Set ID: 873c8e29-6961-4648-bfc8-f91c2086bd94

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: Microcrystalline cellulose, crospovidone, hydroxypropyl cellulose, colloidal silicon dioxide and magnesium stearate. 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-(ß-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 to off-white powder Solubility: Soluble in water, sparingly soluble in methanol pKa: 7.8 (0.3% aqueous solution) pH: 3.5 to 5.5 (5% aqueous solution) Melting Range: 200 to 203°C structure