BEPREVE Ophthalmic solution Ref.[9955] Active ingredients:

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

Product description

BEPREVE (bepotastine besilate ophthalmic solution) 1.5% is a sterile, topically administered drug for ophthalmic use. Each mL of BEPREVE contains 15 mg bepotastine besilate. Bepotastine besilate is designated chemically as (+)4[[(S)-p-chloro-alpha-2-pyridylbenzyl]oxy]-1-piperidine butyric acid monobenzenesulfonate. The chemical structure for bepotastine besilate is:

Bepotastine besilate is a white to pale yellowish-white crystalline powder. The molecular weight of bepotastine besilate is 547.06 daltons. BEPREVE ophthalmic solution is supplied as a sterile, aqueous 1.5% solution, with an approximate pH of 6.8. The osmolality of BEPREVE (bepotastine besilate ophthalmic solution) 1.5% is approximately 295 mOsm/kg.

Each mL of BEPREVE (bepotastine besilate ophthalmic solution) 1.5% contains:

  • Active: bepotastine besilate 15 mg (equivalent to 10.7 mg bepotastine)
  • Inactives: monobasic sodium phosphate dihydrate, sodium chloride, sodium hydroxide to adjust pH, and water for injection, USP.
  • Preservative: benzalkonium chloride 0.005%
Dosage Forms and Strengths

Ophthalmic solution containing bepotastine besilate 15 mg/mL (1.5%).

How Supplied

BEPREVE (bepotastine besilate ophthalmic solution) 1.5% is supplied in a white low density polyethylene bottle with a sterile linear low density polyethylene controlled dropper tip and a white polypropylene cap in the following sizes:

NDC 24208-629-02 5 mL Bottle

NDC 24208-629-01 10 mL Bottle

Drugs

Drug Countries
BEPREVE Canada, United States

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