FACTIVE Tablet Ref.[50460] Active ingredients:

Source: FDA, National Drug Code (US)  Revision Year: 2016 

Product description

FACTIVE (gemifloxacin mesylate) is a synthetic broad-spectrum antibacterial agent for oral administration. Gemifloxacin, a compound related to the fluoroquinolone class of antibiotics, is available as the mesylate salt in the sesquihydrate form. Chemically, gemifloxacin is (R,S)7[(4Z)3(aminomethyl)4(methoxyimino)-1-pyrrolidinyl]-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-1,8-naphthyridine-3-carboxylic acid.

The mesylate salt is a white to light brown solid with a molecular weight of 485.49. Gemifloxacin is considered freely soluble at neutral pH (350 ฮผg/mL at 37ยบC, pH 7.0). Its empirical formula is C18H20FN5O4โ€ขCH4O3S and its chemical structure is:

Each white to off-white, oval, film-coated FACTIVE tablet has breaklines and GE 320 debossed on both faces and contains gemifloxacin mesylate equivalent to 320 mg gemifloxacin. The inactive ingredients are crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, and titanium dioxide.

How Supplied

FACTIVE (gemifloxacin mesylate) is available as white to off-white, oval, film-coated tablets with breaklines and GE 320 debossed on both faces. Each tablet contains gemifloxacin mesylate equivalent to 320 mg of gemifloxacin.

320 mg Unit of Use (CR*) 5’s NDC 44001-321-05
320 mg Unit of Use (CR*) 7’s NDC 44001-321-07

* Child Resistant

Manufactured for: MERUS LABS, Toronto, ON M5K 1H1 Canada

Licensed from LG Life Sciences, Ltd. Seoul, Korea

Drugs

Drug Countries
FACTIVE Brazil, Ecuador, Mexico, Tunisia, Turkey, South Africa

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