SPL Set ID: 0c64bc71-2e7f-4b15-a8e1-acb8de04395f

1 drug(s) with this SPL Set ID

Open DailyMed details

Zolpidem Tartrate ZOLPIDEM TARTRATE
6.25 mg Extended-release
SUN PHARMACEUTICAL INDUSTRIES, INC. FDA Rx Only

Zolpidem tartrate extended-release tablets, USP contains zolpidem tartrate, USP, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem tartrate extended-release tablets, USP are available in 6.25 mg and 12.5 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)­-tartrate (2:1). It has the following structure: Zolpidem tartrate is a white to off-white crystalline powder that is slightly soluble in water, sparingly soluble in alcohol, and propylene glycol. It has a molecular weight of 764.86. Zolpidem tartrate extended-release tablets, USP consist of a coated two-layer tablet: one layer that releases its drug content immediately and another layer that allows a slower release of additional drug content. The 6.25 mg zolpidem tartrate extended-release tablets, USP contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, ferric oxide red, hypromellose, sodium starch glycolate, magnesium stearate, tartaric acid, talc, polyethylene glycol, polysorbate 80. The 12.5 mg zolpidem tartrate extended-release tablets, USP contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, ferric oxide yellow, hypromellose, sodium starch glycolate, magnesium stearate, tartaric acid, talc, polyethylene glycol, polysorbate 80. The imprinting ink contains shellac glaze, black iron oxide, propylene glycol, and ammonium hydroxide. It meets USP Dissolution Test 2. chemical-structure

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