SPL Set ID: 390151d4-5fcb-46e2-92e6-de184827f43d

1 drug(s) with this SPL Set ID

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Cyclobenzaprine Hydrochloride CYCLOBENZAPRINE HYDROCHLORIDE
AMNEAL PHARMACEUTICALS LLC FDA Rx Only

Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C 20 H 21 N·HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pK a of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl, USP is designated chemically as 3-( 5H- dibenzo[ a , d ]cyclohepten-5-ylidene)- N , N -dimethyl-1-propanamine hydrochloride, and has the following structural formula: Cyclobenzaprine hydrochloride, USP is supplied as a 5 mg or 10 mg tablet for oral administration. Cyclobenzaprine hydrochloride tablets USP, 5 mg and 10 mg, contain the following inactive ingredients: croscarmellose sodium, D&C Yellow #10 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Yellow #6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc and titanium dioxide. 1

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