LANOXIN Tablet Ref.[10579] Active ingredients: Digoxin

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

Product description

LANOXIN (digoxin) is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”).

Digoxin is described chemically as (3β,5β,12β)3[(O-2,6-dideoxy-β-D-ribohexopyranosyl(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide.

Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is:

Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine.

LANOXIN is supplied as 62.5 mcg (unscored), 125 mcg (scored), and 250 mcg (scored) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients: corn and potato starches, lactose and magnesium stearate. The 125 mcg tablets contain D&C Yellow No. 10 and FD&C Yellow No. 6, and the 62.5 mcg tablets contain FD&C Yellow No. 6.

Dosage Forms and Strengths

Unscored Tablets: 62.5 mcg are peach, round with “U3A” imprinted on one side.

Scored Tablets: 125 mcg are yellow, round, scored tablets with “Y3B” imprinted on one side.

Scored Tablets: 250 mcg are white, round, scored tablets with “X3A” imprinted on one side.

How Supplied

LANOXIN Tablets have “LANOXIN” on one side and are supplied as follows:

McgScoredColorImprintNDC 59212-xxxx-xx Bottle/100 Unit dose/100
62.5 No Peach U3A 240-55 Not applicable
125 Yes Yellow Y3B 242-55 242-56
250 Yes White X3A 249-55 249-56

LANOXIN is a registered trademark of GlaxoSmithKline.

Mfd. for: Concordia Pharmaceuticals

Distributed by: Amdipharm Limited, 17 Northwood House, Dublin 9, Ireland

Drugs

Drug Countries
LANOXIN Australia, Cyprus, Hong Kong, Ireland, Israel, Lithuania, Malta, Mexico, Netherlands, New Zealand, Singapore, United Kingdom, United States, South Africa

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