SEYSARA Film-coated tablet Ref.[10373] Active ingredients: Sarecycline

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

Product description

SEYSARA (sarecycline) tablets are a tetracycline class drug for oral administration. Sarecycline hydrochloride is chemically described as (4S,4aS,5aR,12aS)4(dimethylamino)-3,10,12,12a-tetrahydroxy-7-[(methoxy-(methyl)-amino)-methyl]-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide monohydrochloride with an empirical formula of C24H29N3O8.HCl and a molecular weight of 523.96.

The structural formula is represented below:

SEYSARA tablets contain 64.5 mg, 107.5 mg, and 161.2 mg of sarecycline hydrochloride equivalent to 60 mg, 100 mg, and 150 mg sarecycline respectively. Inactive ingredients in the tablet formulations are: microcrystalline cellulose, povidone, sodium starch glycolate, and sodium stearyl fumarate. The yellow film coating contains D&C yellow #10 aluminum lake, iron oxide yellow, methacrylic acid copolymer type C, polyethylene glycol, polyvinyl alcohol, sodium bicarbonate, talc, and titatnium dioxide.

Dosage Forms and Strengths

SEYSARA (sarecycline) tablets:

  • 60 mg: capsule-shaped, yellow, film-coated tablets debossed with “S60” on one side and blank on the other side.
  • 100 mg: capsule-shaped, yellow, film-coated tablets debossed with “S100” on one side and blank on the other side.
  • 150 mg: capsule-shaped, yellow, film-coated tablets debossed with “S150” on one side and blank on the other side.
How Supplied

SEYSARA (sarecycline) tablets, 60 mg are capsule-shaped, yellow, film-coated tablets debossed with “S60” on one side and blank on the other side.

Bottles of 30 tablets with child-resistant closure: NDC: 16110-245-30

SEYSARA (sarecycline) tablets, 100 mg are capsule-shaped, yellow, film-coated tablets debossed with “S100” on one side and blank on the other side.

Bottles of 30 tablets with child-resistant closure: NDC: 16110-246-30

SEYSARA (sarecycline) tablets, 150 mg are capsule-shaped, yellow, film-coated tablets debossed with “S150” on one side and blank on the other side.

Bottles of 30 tablets with child-resistant closure: NDC: 16110-247-30

Distributed by: Almirall, LLC, Exton, PA 19341, USA

Drugs

Drug Countries
SEYSARA United States

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