AMMONUL Solution for injection Ref.[10164] Active ingredients: Banzoic acid

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

Product description

AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10% per 10% (a nitrogen binding agent) is a sterile, concentrated, aqueous solution of sodium phenylacetate and sodium benzoate. The pH of the solution is between 6 and 8. Sodium phenylacetate is a crystalline, white to off-white powder with a strong, offensive odor. It is soluble in water. Sodium benzoate is a white and odorless crystalline powder that is readily soluble in water.

Figure 1:

Sodium phenylacetate has a molecular weight of 158.13 and the molecular formula C8H7NaO2. Sodium benzoate has a molecular weight of 144.11 and the molecular formula C7H5NaO2.

Each mL of AMMONUL contains 100 mg of sodium phenylacetate and 100 mg of sodium benzoate, and Water for Injection. Sodium hydroxide and/or hydrochloric acid may have been used for pH adjustment.

AMMONUL injection is a sterile, concentrated solution intended for intravenous administration via a central venous catheter only after dilution [see Dosage and Administration (2)].

Dosage Forms and Strengths

AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10% per 10% is a sterile, concentrated, aqueous solution of sodium phenylacetate and sodium benzoate.

How Supplied

AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10% per 10% is supplied in a sterile, non-pyrogenic, single use glass vial.

NDC 0187-0010-50 single use vial containing 50 mL of sodium phenylacetate and sodium benzoate injection 10% per 10%.

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