# gynazole 1

NDC: 45802-396
Generic name: butoconazole nitrate
Labeler / Manufacturer: Padagis Israel Pharmaceuticals Ltd
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: Abbreviated NDA (generic)
Dosage form: CREAM
Routes: VAGINAL
Marketing started: 20150429

FDA application: ANDA200923

## Active ingredients

- BUTOCONAZOLE NITRATE: 100 mg/5g

## Pharmacological class

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## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"45802-396"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=45802-396
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=125d8ede-db38-4eb9-a6be-19208687f36a