ULORIC Tablet Ref.[11101] Active ingredients: Febuxostat

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

Product description

ULORIC (febuxostat) is a xanthine oxidase inhibitor. The active ingredient in ULORIC is 2-[3-cyano-4-(2-methylpropoxy) phenyl]-4-methylthiazole-5-carboxylic acid, with a molecular weight of 316.38. The empirical formula is C16H16N2O3S.

The chemical structure is:

Febuxostat is a non-hygroscopic, white crystalline powder that is freely soluble in dimethylformamide; soluble in dimethylsulfoxide; sparingly soluble in ethanol; slightly soluble in methanol and acetonitrile; and practically insoluble in water. The melting range is 205°C to 208°C.

ULORIC tablets for oral use contain the active ingredient, febuxostat, and are available in two dosage strengths, 40 mg and 80 mg. Inactive ingredients include lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, sodium croscarmellose, silicon dioxide and magnesium stearate. ULORIC tablets are coated with Opadry II, green.

Dosage Forms and Strengths
  • 40 mg tablets, light green to green, round, debossed with “TAP” and "40"
  • 80 mg tablets, light green to green, teardrop shaped, debossed with “TAP” and "80"
How Supplied

ULORIC 40 mg tablets are light green to green in color, round, debossed with “TAP” on one side and “40” on the other side and supplied as:

NDC Number Size
64764-918-11 Hospital Unit Dose Pack of 100 Tablets
64764-918-30 Bottle of 30 Tablets
64764-918-90 Bottle of 90 Tablets
64764-918-18 Bottle of 500 Tablets

ULORIC 80 mg tablets are light green to green in color, teardrop shaped, debossed with “TAP” on one side and “80” on the other side and supplied as:

NDC Number Size
64764-677-11 Hospital Unit Dose Pack of 100 Tablets
64764-677-30 Bottle of 30 Tablets
64764-677-13 Bottle of 100 Tablets
64764-677-19 Bottle of 1000 Tablets

Drugs

Drug Countries
ULORIC Canada, United States

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