NESINA Film-coated tablet Ref.[10885] Active ingredients: Alogliptin

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

Product description

NESINA tablets contain the active ingredient alogliptin, which is a selective, orally bioavailable inhibitor of the enzymatic activity of dipeptidyl peptidase-4 (DPP-4).

Chemically, alogliptin is prepared as a benzoate salt, which is identified as 2-({6-[(3R)-3-aminopiperidin-1-yl]-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl}methyl)benzonitrile monobenzoate. It has a molecular formula of C18H21N5O2â€ĒC7H6O2 and a molecular weight of 461.51 daltons.

The structural formula is:

Alogliptin benzoate is a white to off-white crystalline powder containing one asymmetric carbon in the aminopiperidine moiety. It is soluble in dimethylsulfoxide, sparingly soluble in water and methanol, slightly soluble in ethanol and very slightly soluble in octanol and isopropyl acetate.

Each NESINA tablet contains 34 mg, 17 mg or 8.5 mg alogliptin benzoate, which is equivalent to 25 mg, 12.5 mg or 6.25 mg, respectively, of alogliptin and the following inactive ingredients: mannitol, microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, ferric oxide (red or yellow) and polyethylene glycol, and is marked with printing ink (Gray F1).

Dosage Forms and Strengths
  • 25 mg tablets are light red, oval, biconvex, film-coated, with “TAK ALG-25” printed on one side.
  • 12.5 mg tablets are yellow, oval, biconvex, film-coated, with “TAK ALG-12.5” printed on one side.
  • 6.25 mg tablets are light pink, oval, biconvex, film-coated, with “TAK ALG-6.25” printed on one side.
How Supplied

NESINA tablets are available as film-coated tablets containing 25 mg, 12.5 mg or 6.25 mg of alogliptin as follows:

25 mg tablet: light red, oval, biconvex, film-coated, with “TAK ALG-25” printed on one side, available in:

NDC 64764-250-30 Bottles of 30 tablets
NDC 64764-250-90 Bottles of 90 tablets
NDC 64764-250-50 Bottles of 500 tablets

12.5 mg tablet: yellow, oval, biconvex, film-coated, with “TAK ALG-12.5” printed on one side, available in:

NDC 64764-125-30 Bottles of 30 tablets
NDC 64764-125-90 Bottles of 90 tablets
NDC 64764-125-50 Bottles of 500 tablets

6.25 mg tablet: light pink, oval, biconvex, film-coated, with “TAK ALG-6.25” printed on one side, available in:

NDC 64764-625-30 Bottles of 30 tablets
NDC 64764-625-90 Bottles of 90 tablets

Drugs

Drug Countries
NESINA Australia, Brazil, Canada, Hong Kong, Japan, Singapore, United States

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