DUREZOL Emulsion Ref.[10018] Active ingredients: Difluprednate

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

DUREZOL (difluprednate ophthalmic emulsion) 0.05% is a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. The chemical name is 6α,9difluoro-11β,17,21-trihydroxypregna-1,4-diene-3,20-dione 21-acetate 17-butyrate (CAS number 23674-86-4).

Difluprednate is represented by the following structural formula:

Difluprednate has a molecular weight of 508.56 g/mol, and the empirical formula is C27H34F2O7.

Each mL of DUREZOL contains:

ACTIVE: difluprednate 0.5 mg (0.05%)

INACTIVE: boric acid, castor oil, edetate disodium, glycerin, polysorbate 80, sodium acetate, sodium hydroxide (to adjust the pH to 5.2 to 5.8), water for injection. The emulsion is essentially isotonic with a tonicity of 304 to 411 mOsm/kg

PRESERVATIVE: sorbic acid 0.1%

Dosage Forms and Strengths

DUREZOL contains 0.05% difluprednate as a sterile preserved emulsion for topical ophthalmic administration.

How Supplied

DUREZOL (difluprednate ophthalmic emulsion) 0.05% is a sterile, aqueous topical ophthalmic emulsion supplied in an opaque plastic bottle with a controlled drop tip and a pink cap in the following sizes:

5 mL in a 8 mL bottle NDC 0065-9240-07

Drugs

Drug Countries
DUREZOL Canada, Ecuador, United States

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