SPL Set ID: 951caefe-6e18-48ff-9567-beb545b09c25

1 drug(s) with this SPL Set ID

Open DailyMed details

Rabeprazole Sodium RABEPRAZOLE
#50 (RABEPRAZOLE) 20 mg Delayed-release
AMNEAL PHARMACEUTICALS LLC FDA Rx Only

The active ingredient in rabeprazole sodium delayed-release tablets is rabeprazole sodium, USP which is a proton pump inhibitor. It is a substituted benzimidazole known chemically as 2-[[[4-(3-­methoxypropoxy)-3-methyl-2-pyridinyl]-methyl]sulfinyl]-1 H –benzimidazole sodium salt. It has an empirical formula of C 18 H 20 N 3 NaO 3 S and a molecular weight of 381.42. Rabeprazole sodium, USP is a white to slightly yellowish-white solid. It is very soluble in water and methanol, freely soluble in ethanol, chloroform, and ethyl acetate and insoluble in ether and n- hexane. The stability of rabeprazole sodium is a function of pH; it is rapidly degraded in acid media, and is more stable under alkaline conditions. The structural figure is: Figure 1 Rabeprazole sodium, USP is available for oral administration as delayed-release, enteric-coated tablets containing 20 mg of rabeprazole sodium, USP. Inactive ingredients of the 20 mg tablet are ammonium hydroxide, crospovidone, diethyl phthalate, ethyl cellulose, hydroxypropyl cellulose, hypromellose phthalate, iron oxide black, iron oxide yellow, light magnesium oxide, magnesium stearate, mannitol, propylene glycol, shellac, sodium stearyl fumarate, talc, and titanium dioxide. 1

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