Source: FDA, National Drug Code (US) Revision Year: 2020
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 |
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DUREZOL contains 0.05% difluprednate as a sterile preserved emulsion for topical ophthalmic administration. |
| How Supplied |
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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 |
| Drug | Countries | |
|---|---|---|
| DUREZOL | Canada, Ecuador, United States |
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