SPL Set ID: 5e1f739a-eb81-43d8-9a14-89f32b7e1ba1

Daptomycin for Injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus . The chemical name is N -decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl- threo -3-methyl-L-glutamyl-3-anthraniloyl-L-alanine ε 1 -lactone. The chemical structure is: The empirical formula is C 72 H 101 N 17 O 26 ; the molecular weight is 1620.67. Daptomycin for Injection is supplied in a single-dose vial as a sterile, preservative-free, pale yellow to light brown, lyophilized powder or cake containing 350 mg or 500 mg of daptomycin for intravenous (IV) use following reconstitution [see Dosage and Administration (2.7) ]. Daptomycin for Injection 350 mg per vial contains 350 mg daptomycin, 188.1 mg of L-arginine, 100.5 mg of L-histidine, and 28.3 mg of L-isoleucine. Hydrochloric acid is used to adjust the pH. Daptomycin for Injection 500 mg per vial contains 500 mg daptomycin, 268.7 mg of L-arginine, 143.6 mg of L-histidine, and 40.5 mg of L-isoleucine. Hydrochloric acid is used to adjust the pH. The pH of the solution upon reconstitution is between 5.7 and 6.7. Freshly reconstituted solutions of Daptomycin for Injection range in color from pale yellow to light brown. Chemical Structure