ROBINUL Tablet Ref.[50367] Active ingredients: Glycopyrronium

Source: FDA, National Drug Code (US)  Revision Year: 2022 

Product description

ROBINUL and ROBINUL FORTE tablets contain synthetic anticholinergic glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentyl hydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide. The molecular formula for glycopyrrolate is C19H28BrNO3, the molecular weight is 398.3 g/mol, and the structural formula is:

Each ROBINUL tablet contains glycopyrrolate, USP 1 mg, as the active ingredient. Each ROBINUL FORTE tablet contains glycopyrrolate, USP 2 mg, as the active ingredient. The inactive ingredients are dibasic calcium phosphate, lactose monohydrate, magnesium stearate, povidone, and sodium starch glycolate.

Dosage Forms and Strengths

Tablets:

  • 1 mg, white, round, flat-faced, beveled-edge tablet, debossed “CS” and “007” on one side and functionally scored on the other side.
  • 2 mg, white, round, flat-faced, beveled-edge tablet, debossed “CS” score “008” on one side and plain on the other side.
How Supplied

ROBINUL (glycopyrrolate) tablets, 1 mg are white, round, flat-faced, beveled-edge tablet, debossed “CS” and “007” on one side and functionally scored on the other side. Available as

  • Bottles of 30 NDC 70199-007-30
  • Bottles of 90 NDC 70199-007-90

ROBINUL FORTE (glycopyrrolate) tablets, 2 mg are white, round, flat-faced, beveled-edge tablet, debossed “CS” score “008” on one side and plain on the other side. Available as

  • Bottles of 30 NDC 70199-008-30
  • Bottles of 90 NDC 70199-008-90

Manufactured for: Casper Pharma LLC, East Brunswick, NJ 08816

Manufactured by: Suven Pharmaceuticals Limited, Telangana, India

Drugs

Drug Countries
ROBINUL Austria, Estonia, Finland, New Zealand, Romania, United States, South Africa

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