SOLOSEC Oral granules Ref.[10387] Active ingredients: Secnidazole

Source: FDA, National Drug Code (US)  Revision Year: 2019 

Product description

The active ingredient in SOLOSEC Oral Granules is secnidazole (also named 1-(2- hydroxypropyl)-2-methyl-5-nitroimidazole and 1-(2-methyl-5-nitro-1H-imidazol-1-yl) propan-2- ol), a nitroimidazole antimicrobial.

The molecular formula of secnidazole is C7H11N3O3, the molecular weight is 185.18 and the chemical structure is:

Each packet of SOLOSEC contains 4.8 g of off-white to slightly yellowish granules, which contain 2 g of secnidazole and the following inactive ingredients: Eudragit NE30D (ethyl acrylate methyl methacrylate copolymer), polyethylene glycol 4000, povidone, sugar spheres, and talc. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).

Dosage Forms and Strengths

Oral Granules: 2 g, of off-white to slightly yellowish granules with 4.8 g net weight, packed in a unit-of-use child-resistant foil packet.

How Supplied

SOLOSEC (secnidazole) Oral Granules, 2 g, consists of off-white to slightly yellowish granules containing secnidazole. SOLOSEC is supplied in a unit-of-use package containing one packet of granules in an individual carton. Each packet contains 4.8 g of granules containing 2 g secnidazole. SOLOSEC is supplied as follows:

NDC 27437-051-01 carton containing one unit-of-use 2 g packet

Manufactured for and Distributed by: Lupin Pharmaceuticals, Inc, Baltimore, MD 21202

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