SPL Set ID: b28a4f3d-0aae-050d-e053-2995a90aa4a6

1 drug(s) with this SPL Set ID

Open DailyMed details

Ziprasidone Mesylate ZIPRASIDONE MESYLATE
20 mg Injection
FOSUN PHARMA USA INC. FDA Rx Only

Ziprasidone mesylate for injection contains the active moiety, ziprasidone, in the form of ziprasidone mesylate salt for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C 21 H 21 ClN 4 OS (free base of ziprasidone) represents the following structural formula: Structure.jpg Ziprasidone mesylate for injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2 benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. The empirical formula is C 21 H 21 ClN 4 OS • CH 3 SO 3 H • 3H 2 O and its molecular weight is 563.09. Ziprasidone mesylate for injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [see Dosage and Administration (2.4) ]. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD). structure.jpg

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