DIMENHYDRINATE Solution for injection Ref.[10838] Active ingredients: Dimenhydrinate

Source: FDA, National Drug Code (US)  Revision Year: 2019 

Product description

Dimenhydrinate, an anti-nauseant/antiemetic, is the 8-chlorotheophylline salt of diphenhydramine. It contains not less than 53% and not more than 55.5% of diphenhydramine, and not less than 44% and not more than 47% of 8-chlorotheophylline, calculated on the dried basis.

Chemically, it is 8-chlorotheophylline compound with 2(diphenylmethoxy)-N,N-dimethylethylamine (1:1), and the structural formula is:

C17H21NO•C7H7ClN4O2

M.W. 469.96

Dimenhydrinate Injection, USP contains a sterile solution of Dimenhydrinate 50 mg/mL; Propylene Glycol 50%; Benzyl Alcohol 5% as preservative; and Water for Injection q.s. Sodium Hydroxide and/or Hydrochloric Acid may have been used to adjust pH.

How Supplied

DimenhyDRINATE Injection, USP, 50 mg/mL is available in multiple dose amber vials, as follows:

Product No. NDC No. Strength Vial Size
361601 63323-366-0150 mg/mL1 mL in 2 mL vial, in packages of 25.
361610 63323-366-10 50 mg/mL 10 mL in a 10 mL vial, packaged individually.

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