TRULANCE Tablet Ref.[10170] Active ingredients: Plecanatide

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

Product description

TRULANCE (plecanatide) is a guanylate cyclase-C (GC-C) agonist. Plecanatide is a 16 amino acid peptide with the following chemical name: L-Leucine, L-asparaginyl-L-α-aspartyl-L-α-glutamyl-L-cysteinyl-L-α-glutamyl-L-leucyl-L-cysteinyl-L-valyl-L-asparaginyl-L-valyl-L-alanyl-L-cysteinyl-L-threonylglycyl-L-cysteinyl-, cyclic (4→12),(7→15)-bis(disulfide).

The molecular formula of plecanatide is C65H104N18O26S4 and the molecular weight is 1682 Daltons.

The amino acid sequence for plecanatide is shown below:

The solid lines linking cysteines illustrate disulfide bridges.

Plecanatide is an amorphous, white to off-white powder. It is soluble in water. TRULANCE tablets are supplied as 3 mg tablets for oral administration. The inactive ingredients are magnesium stearate and microcrystalline cellulose.

Dosage Forms and Strengths

TRULANCE Tablets:

3 mg: white to off-white, plain, round tablet debossed with “SP” on one side and “3” for 3 mg on the other side.

How Supplied

TRULANCE tablets are packaged in an aluminum foil unit dose blister pack of 30 in a child-resistant pack or in a white, opaque, high-density polyethylene round bottle with a screw-top polypropylene child-resistant cap and heat-activated induction seal. Each bottle container-closure system also contains a desiccant and a polyester coil.

TRULANCE 3 mg tablets are white to off-white, plain and round, debossed with “SP” on one side and “3” for 3 mg on the other side and supplied as:

NDC NumberSize
65649-003-30 Bottle of 30
70194-003-30 Aluminum foil unit dose blister pack of 30 in a child-resistant pack

Drugs

Drug Countries
TRULANCE United States

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