LINZESS Capsule, gelatin coated Ref.[49660] Active ingredients: Linaclotide

Source: FDA, National Drug Code (US)  Revision Year: 2021 

Product description

LINZESS (linaclotide) is a guanylate cyclase-C (G-CC) agonist. Linaclotide is a 14-amino acid peptide with the following chemical name: L-cysteinyl-L-cysteinyl-L-glutamyl-L-tyrosyl-L-cysteinyl-L-cysteinyl-L-asparaginyl-L-prolyl-L-alanyl-L-cysteinyl-L-threonyl-glycyl-L-cysteinyl-L-tyrosine, cyclic (1-6), (2-10), (5-13)-tris (disulfide).

The molecular formula of linaclotide is C59H79N15O21S6 and its molecular weight is 1526.8. The amino acid sequence for linaclotide is shown below:

Linaclotide is an amorphous, white to off-white powder. It is slightly soluble in water and aqueous sodium chloride (0.9%). LINZESS contains linaclotide-coated beads in hard gelatin capsules. LINZESS is available as 72 mcg, 145 mcg and 290 mcg capsules for oral administration.

The inactive ingredients of LINZESS 72 mcg capsules include: calcium chloride dihydrate, L-histidine, microcrystalline cellulose, polyvinyl alcohol, and talc. The components of the capsule shell include gelatin and titanium dioxide.

The inactive ingredients of LINZESS 145 mcg and 290 mcg capsules include: calcium chloride dihydrate, hypromellose, L-leucine, and microcrystalline cellulose. The components of the capsule shell include gelatin and titanium dioxide.

Dosage Forms and Strengths

LINZESS capsules are white to off-white opaque:

  • 72 mcg; gray imprint "FL 72"
  • 145 mcg; gray imprint "FL 145"
  • 290 mcg; gray imprint "FL 290"
How Supplied
LINZESS Capsule Strength Description Packaging NDC number
72 mcg White to off-white opaque hard gelatin capsules with gray imprint “FL 72” Bottle of 30 0456-1203-30
145 mcg White to off-white opaque hard gelatin capsules with gray imprint “FL 145” Bottle of 30 0456-1201-30
290 mcg White to off-white opaque hard gelatin capsules with gray imprint “FL 290” Bottle of 30 0456-1202-30

Drugs

Drug Countries
LINZESS Hong Kong, Japan, United States

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