AMARYL Tablet Ref.[10536] Active ingredients: Glimepiride

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

Product description

AMARYL is an oral sulfonylurea that contains the active ingredient glimepiride. Chemically, glimepiride is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]phenyl]sulfonyl]3(trans-4-methylcyclohexyl)urea (C24H34N4O5S) with a molecular weight of 490.62. Glimepiride is a white to yellowish-white, crystalline, odorless to practically odorless powder and is practically insoluble in water.

The structural formula is:

AMARYL tablets contain the active ingredient glimepiride and the following inactive ingredients: lactose (hydrous), sodium starch glycolate, povidone, microcrystalline cellulose, and magnesium stearate. In addition, AMARYL 1 mg tablets contain Ferric Oxide Red, AMARYL 2 mg tablets contain Ferric Oxide Yellow and FD&C Blue #2 Aluminum Lake, and AMARYL 4 mg tablets contain FD&C Blue #2 Aluminum Lake.

Dosage Forms and Strengths

AMARYL is formulated as tablets of:

  • 1 mg (pink, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)
  • 2 mg (green, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)
  • 4 mg (blue, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side)
How Supplied

AMARYL tablets are available in the following strengths and package sizes:

  • 1 mg (pink, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0221-10)
  • 2 mg (green, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0222-10)
  • 4 mg (blue, flat-faced, oblong with notched sides at double bisect, imprinted with “AMA RYL” on one side) in bottles of 100 (NDC 0039-0223-10)

sanofi-aventis U.S. LLC, Bridgewater, NJ 08807, A SANOFI COMPANY

Drugs

Drug Countries
AMARYL Austria, Australia, Brazil, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Malta, Mexico, Netherlands, Poland, Romania, Singapore, Turkey, United States, South Africa
 
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