SPL Set ID: b14feecc-04c6-4b2d-ba55-2e1dbef6b0d7

1 drug(s) with this SPL Set ID

Open DailyMed details

Duloxetine DULOXETINE
#35 20 mg Delayed-release
CAMBER PHARMACEUTICALS, INC. FDA Rx Only

Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (γS)-N-Methyl-γ-(1-napthalenyloxy)-2-thiophenepropanamine hydrochloride. The empirical formula is C 18 H 19 NOS•HCl, which corresponds to a molecular weight of 333.87. The structural formula is: Duloxetine hydrochloride, USP is an off-white to white colored crystalline powder which is freely soluble in methanol and sparingly soluble in water. Each capsule contains film-coated pellets of 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. Inactive ingredients include crospovidone, FD & C Blue 2, gelatin, hydroxy propyl methyl cellulose acetate succinate, hypromellose, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide and triethyl citrate. In addition, the 20 mg and 60 mg capsules also contain iron oxide yellow. The imprinting ink contains propylene glycol, shellac, and strong ammonia solution. The 20 mg capsule also contains black iron oxide and potassium hydroxide. The 30 mg capsule also contains yellow iron oxide. The 60 mg capsule also contains potassium hydroxide and titanium dioxide. duloxetinestructure

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