# ZTALMY

NDC: 81583-100
Generic name: ganaxolone
Labeler / Manufacturer: Immedica Pharma US Inc
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: New Drug Application (innovator)
Dosage form: SUSPENSION
Routes: ORAL
Marketing started: 20220606

FDA application: NDA215904

## Active ingredients

- GANAXOLONE: 50 mg/mL

## Pharmacological class

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## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"81583-100"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=81583-100
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d91612c4-b03a-4be4-a1ee-6a13e3b83d4e