SPL Set ID: c0167aec-a89d-4e96-afe5-2ccf3e89fe72

XACDURO (sulbactam for injection and durlobactam for injection) is an antibacterial co-packaged product containing sulbactam sodium, a penicillin derivative beta-lactam antibacterial and beta-lactamase inhibitor, and durlobactam sodium, a diazabicyclooctane beta-lactamase inhibitor, for intravenous administration. Sulbactam Sodium Sulbactam sodium is a beta-lactam antibacterial and a beta-lactamase inhibitor. Chemically, sulbactam sodium is sodium penicillinate sulfone; sodium (2S, 5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylate 4,4-dioxide. Sulbactam is a white to off-white crystalline powder that is freely soluble in water and its empirical formula is C 8 H 10 NNaO 5 S with a molecular weight of 255.22. Figure 1: Chemical structure of sulbactam sodium Figure 1 Durlobactam Sodium Durlobactam is a beta-lactamase inhibitor antibacterial drug. Chemically, durlobactam sodium is sodium (2 S ,5 R )-2-carbamoyl-3-methyl-7-oxo-1,6-diazabicyclo[3.2.1]oct-3-en-6-yl sulfate. Durlobactam sodium is the pure (2S,5R)-enantiomer of the trans diastereoisomer. It is a white to yellow amorphous powder that is freely soluble in water. The empirical formula is C 8 H 10 N 3 NaO 6 S and the molecular weight (sodium salt) is 299.23. Figure 2: Chemical structure of durlobactam sodium XACDURO is supplied as a co-packaged kit containing three single-dose vials each containing sterile powder for reconstitution: one clear single-dose vial contains 1 g sulbactam (equivalent to 1.1 g sulbactam sodium) and two amber single-dose vials each contain 0.5 g durlobactam (equivalent to 0.54 g durlobactam sodium) together with sodium hydroxide and hydrochloric acid used for pH adjustment. Figure 2