Source: FDA, National Drug Code (US) | Revision Year: 2019 | Publisher:
CORTEF Tablets contain hydrocortisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone USP is white to practically white, odorless, crystalline powder with a melting point of about 215°C. It is very slightly soluble in water and in ether; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform.
The chemical name for hydrocortisone is pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-. Its molecular weight is 362.46 and the structural formula is as outlined below.
CORTEF Tablets are available for oral administration in three strengths: each tablet contains either 5 mg, 10 mg, or 20 mg of hydrocortisone. Inactive ingredients: calcium stearate, corn starch, lactose, mineral oil, sorbic acid, sucrose.
CORTEF Tablets are available in the following strengths and package sizes:
5 mg (white, round, scored, imprinted CORTEF 5): Bottles of 50 NDC 0009-0012-01
10 mg (white, round, scored, imprinted CORTEF 10): Bottles of 100 NDC 0009-0031-01
20 mg (white, round, scored, imprinted CORTEF 20): Bottles of 100 NDC 0009-0044-01
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