Source: FDA, National Drug Code (US) Revision Year: 2020
Artesunate for Injection 110 mg contains artesunate, a semi-synthetic artemisinin derivative, that is intended for intravenous administration. Artesunate is an antimalarial drug.
The structural formula is:
Artesunate is a white or almost white powder with a molecular weight of 384.43. The chemical name is butanedioic acid, mono[(3R,5aS,6R,8aS,9R,10S,12R,12aR)-decahydro-3,6,9-trimethyl-3,12-epoxy-12H-pyrano[4,3-j]-1,2-benzodioxepin-10-yl] ester.
The empirical formula is C19H28O8.
Artesunate for Injection is supplied as white or almost white sterile powder for constitution. Each 20 mL glass single-dose vial contains 110 mg of artesunate for constitution with 11 mL of the supplied sterile diluent. The constituted solution should be a colorless solution.
Each single-dose vial of the supplied sterile diluent contains 12 mL of a sterile diluent. Each 11 mL of the sterile diluent that is used for constitution contains 24.1 mg sodium phosphate monobasic monohydrate and 443.6 mg sodium phosphate dibasic anhydrous in water for injection. Sodium hydroxide and phosphoric acid are used to adjust the pH to 7.9-8.1.
The pH specification for the constituted solution is 7.2-7.7 and the measured osmolality is 305-317 mOsm/kg.
| Dosage Forms and Strengths |
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For Injection: 110 mg of artesunate as a sterile white or almost white, fine crystalline powder in a clear glass single-dose vial for constitution. |
| How Supplied |
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Artesunate for Injection is supplied as follows:
Artesunate for Injection single-dose vial: NDC 73607-001-01 Sterile Diluent for Constitution single-dose vial: NDC 73607-001-02 Packages of 4 total vials (2 vials of Artesunate for Injection, 110 mg and 2 vials sterile diluent for Artesunate for Injection): NDC 73607-001-11 Packages of 8 total vials (4 vials of Artesunate for Injection, 110 mg and 4 vials sterile diluent for Artesunate for Injection): NDC 73607-001-10 Manufactured for Amivas LLC, 1209 Orange St, Wilmington Delaware 19801, USA |
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