SPL Set ID: dbe34bc1-06b2-493f-8859-e8b143357aa8

1 drug(s) with this SPL Set ID

Open DailyMed details

BENDAMUSTINE HYDROCHLORIDE BENDAMUSTINE HYDROCHLORIDE
EUGIA US LLC FDA Rx Only

Bendamustine hydrochloride, USP is an alkylating agent. The chemical name of bendamustine hydrochloride, USP is 4-[5-[Bis(2-chloroethyl)amino]-1-methylbenzimidazol-2-yl]butanoic acid hydrochloride monohydrate. Its molecular formula is C 16 H 21 Cl 2 N 3 O 2 .HCl.H 2 O and the molecular weight is 412.74. Bendamustine hydrochloride, USP contains a mechlorethamine group and a benzimidazole heterocyclic ring with a butyric acid substituent, and has the following structural formula: Bendamustine hydrochloride for injection, USP (25 mg/vial or 100 mg/vial lyophilized powder) Bendamustine hydrochloride for injection, USP 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, USP and 42.5 mg of mannitol, USP. Each 100 mg vial contains 100 mg of bendamustine hydrochloride, USP and 170 mg of mannitol, USP. The pH of the reconstituted solution is 2.5 to 3.5. Chemical Structure

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