Source: FDA, National Drug Code (US) Revision Year: 2019
ACTOS tablets are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone.
Pioglitazone [(±)5[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]2,4] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown:
Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3S•HCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether.
ACTOS is available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate NF, hydroxypropylcellulose NF, carboxymethylcellulose calcium NF, and magnesium stearate NF.
| Dosage Forms and Strengths |
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Round tablet contains pioglitazone as follows:
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| How Supplied |
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ACTOS is available in 15 mg, 30 mg, and 45 mg tablets as follows: 15 mg tablet: White to off-white, round, convex, nonscored tablet with “ACTOS” on one side, and “15” on the other, available in: NDC 64764-151-04 Bottles of 30 30 mg tablet: White to off-white, round, flat, nonscored tablet with “ACTOS” on one side, and “30” on the other, available in: NDC 64764-301-14 Bottles of 30 45 mg tablet: White to off-white, round, flat, nonscored tablet with “ACTOS” on one side, and “45” on the other, available in: NDC 64764-451-24 Bottles of 30 Distributed by: Takeda Pharmaceuticals America, Inc., Deerfield, IL 60015 ACTOS is a trademark of Takeda Pharmaceutical Company Limited registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc. |
| Drug | Countries | |
|---|---|---|
| ACTOS | Austria, Australia, Estonia, Spain, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States |
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