BENICAR Film-coated tablet Ref.[49687] Active ingredients: Olmesartan medoxomil

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

Product description

Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist.

Olmesartan medoxomil is described chemically as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate.

Its empirical formula is C29H30N6O6 and its structural formula is:

Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol. Benicar is available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, and (5 mg only) yellow iron oxide.

Dosage Forms and Strengths
  • 5 mg yellow, round, film-coated, non-scored tablets debossed with Sankyo on one side and C12 on the other side.
  • 20 mg white, round, film-coated, non-scored tablets debossed with Sankyo on one side and C14 on the other side.
  • 40 mg white, oval-shaped, film-coated, non-scored tablets debossed with Sankyo on one side and C15 on the other side.
How Supplied

Benicar is supplied as yellow, round, film-coated, non-scored tablets containing 5 mg of olmesartan medoxomil, as white, round, film-coated, non-scored tablets containing 20 mg of olmesartan medoxomil, and as white, oval-shaped, film-coated, non-scored tablets containing 40 mg of olmesartan medoxomil. Tablets are debossed with Sankyo on one side and C12, C14, or C15 on the other side of the 5, 20, and 40 mg tablets, respectively.

Tablets are supplied as follows:

 5 mg 20 mg 40 mg
Bottle of 30 NDC 65597-101-30 NDC 65597-103-30 NDC 65597-104-30
Bottle of 90 Not available NDC 65597-103-90 NDC 65597-104-90
Blister 10 cards × 10 Not available NDC 65597-103-10 NDC 65597-104-10
Blister 1 card × 30 Not available NDC 65597-103-03 NDC 65597-104-03
Carton of 6 cards × 30 Not available NDC 65597-103-06 NDC 65597-104-06

Manufactured for Daiichi Sankyo, Inc., Basking Ridge, NJ 07920

Drugs

Drug Countries
BENICAR Brazil, United States
 
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