Source: FDA, National Drug Code (US) Revision Year: 2020
FLUORESCITE (fluorescein injection, USP) 10% contains fluorescein sodium (equivalent to fluorescein 10% w/v). It is a sterile solution for use intravenously as a diagnostic aid. Its chemical name is spiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one, 3’6'-dihydroxy, disodium salt.
The active ingredient is represented by the chemical structure:
FLUORESCITE (fluorescein injection, USP) 10% is supplied as a sterile, unpreserved, unit dose aqueous solution, that has a pH of 8.0–9.8 and an osmolality of 572-858 mOsm/kg.
Active ingredient: fluorescein sodium
Inactive Ingredients: Sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection.
| Dosage Forms and Strengths |
|---|
|
Single use 5 mL vial containing 100 mg/mL fluorescein. |
| How Supplied |
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FLUORESCITE (fluorescein injection, USP) 10% is supplied in a single use 5 mL glass vial with a gray FluroTec coated chlorobutyl stopper and purple flip-off aluminum seal. The vial stopper is not made with natural rubber latex. The vial contains a sterile, red-orange solution of fluorescein sodium. NDC 0065-0092-05 Distributed By: ALCON LABORATORIES, INC., Fort Worth, Texas 76134 USA |
| Drug | Countries | |
|---|---|---|
| FLUORESCITE | Canada, Estonia, Hong Kong, Japan, New Zealand, Turkey, United States |
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