SPL Set ID: 39d53698-57fa-7c99-fc5b-f52a55684826
1 drug(s) with this SPL Set ID
TREANDA (bendamustine hydrochloride) is an alkylating agent. The chemical name of bendamustine hydrochloride is 1H-benzimidazole-2-butanoic acid, 5-[bis(2-chloroethyl)amino]-1 methyl-, monohydrochloride. Its empirical molecular formula is C 16 H 21 Cl 2 N 3 O 2 ∙ HCl, and the molecular weight is 394.7. Bendamustine hydrochloride contains a mechlorethamine group and a benzimidazole heterocyclic ring with a butyric acid substituent, and has the following structural formula: TREANDA Injection (45 mg/0.5 mL or 180 mg/2 mL solution) TREANDA (bendamustine HCl) Injection for intravenous use is supplied as a sterile clear colorless to yellow solution in a single-dose vial. Each 0.5 mL vial contains 45 mg of bendamustine hydrochloride, 162 mg of Propylene Glycol, USP and 293 mg of N,N-Dimethylacetamide, EP. Each 2 mL vial contains 180 mg of bendamustine hydrochloride, 648 mg of Propylene Glycol, USP and 1172 mg of N,N-Dimethylacetamide, EP. An overfill of 0.2 mL is included in each vial. TREANDA for Injection (25 mg/vial or 100 mg/vial lyophilized powder) TREANDA (bendamustine HCl) for Injection for intravenous use is supplied as a sterile non-pyrogenic white to off-white lyophilized powder in a single-dose vial. Each 25-mg vial contains 25 mg of bendamustine hydrochloride and 42.5 mg of mannitol, USP. Each 100-mg vial contains 100 mg of bendamustine hydrochloride and 170 mg of mannitol, USP. The pH of the reconstituted solution is 2.5 to 3.5. Structural Formula