# AZASITE

NDC: 82584-307
Generic name: azithromycin monohydrate
Labeler / Manufacturer: Thea Pharma Inc.
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: New Drug Application (innovator)
Dosage form: SOLUTION/ DROPS
Routes: OPHTHALMIC
Marketing started: 20221101

FDA application: NDA050810

## Active ingredients

- AZITHROMYCIN MONOHYDRATE: 10 mg/mL

## Pharmacological class

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## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"82584-307"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=82584-307
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0c5d6f5e-18ea-436f-8c62-bbaf66effe3d