Source: FDA, National Drug Code (US) Revision Year: 2020
MYTESI (crofelemer) delayed-release tablets is an anti-diarrheal, enteric-coated drug product for oral administration. It contains 125 mg of crofelemer, a botanical drug substance that is derived from the red latex of Croton lechleri Müll. Arg. Crofelemer is an oligomeric proanthocyanidin mixture primarily composed of (+)–catechin, (-)–epicatechin, (+)–gallocatechin, and (-)–epigallocatechin monomer units linked in random sequence, as represented below. The average degree of polymerization for the oligomers ranges between 5 and 7.5, as determined by phloroglucinol degradation.
R = H or OH range n = 3 to 5.5
Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose.
Coating ingredients: ethylacrylate and methylacrylate copolymer dispersion, talc, triethyl citrate, and white dispersion which contains xanthan gum, titanium dioxide, propyl paraben, and methyl paraben.
| Dosage Forms and Strengths |
|---|
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Delayed-Release Tablets: 125 mg of crofelemer as a white, oval, delayed-release tablet printed on one side with 125SLXP. |
| How Supplied |
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MYTESI (crofelemer) 125 mg delayed-release tablets are white, oval tablets printed on one side with 125SLXP. They are available in the following package size: Bottles of 60: NDC 70564-802-60 |
| Drug | Countries | |
|---|---|---|
| MYTESI | United States |
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