MENEST Film-coated tablet Ref.[50205] Active ingredients: Estrogens, esterified

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

Esterified estrogens is a mixture of the sodium salts of the sulfate esters of the estrogenic substances, principally estrone, that are of the type excreted by pregnant mares. It contains the concomitant component, 17α-estradiol. The content of total esterified estrogens is not less than 90 percent and not more than 110 percent of the labeled amount. Esterified estrogens contain not less than 75 percent and not more than 85 percent of sodium estrone sulfate, and not less than 6 percent and not more than 15 percent of sodium equilin sulfate, in such proportion that the total of these two components is not less than 90 percent, all percentages being calculated on the basis of the total esterified estrogens content.

Inactive Ingredients

Ethyl cellulose, fragrances, hydroxypropyl cellulose, hypromellose 2910, lactose, magnesium stearate, methylcellulose, polyethylene glycol, sodium bicarbonate, shellac, starch, stearic acid, titanium dioxide, and vanillin. Dyes in the form of aluminum lakes are contained in each tablet strength as follows:

0.3 mg Tablet: FD&C Yellow No. 6, D&C Yellow No. 10.

0.625 mg Tablet: FD&C Yellow No. 6, D&C Yellow No. 10.

1.25 mg Tablet: FD&C Yellow No. 6, D&C Yellow No. 10, FD&C Blue No. 1.

2.5 mg Tablet: D&C Red No. 30.

How Supplied

Tablets:

0.3 mg yellow, film-coated oblong tablet imprinted with M72
100’s: NDC 61570-072-01

0.625 mg orange, film-coated oblong tablet imprinted with M73
100’s: NDC 61570-073-01

1.25 mg green, film-coated oblong tablet imprinted with M74
100’s: NDC 61570-074-01

2.5 mg pink, film-coated oblong tablet imprinted with M75
50’s: NDC 61570-075-50

Drugs

Drug Countries
MENEST United States

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