# Budesonide and formoterol fumarate dihydrate

NDC: 0480-3080
Generic name: Budesonide and formoterol fumarate dihydrate
Labeler / Manufacturer: Teva Pharmaceuticals, Inc.
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: Abbreviated NDA (generic)
Dosage form: AEROSOL, METERED
Routes: RESPIRATORY (INHALATION)
Marketing started: 20260527

FDA application: ANDA212212

## Active ingredients

- BUDESONIDE: 80 ug/1
- FORMOTEROL FUMARATE: 4.5 ug/1

## Pharmacological class

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## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"0480-3080"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=0480-3080
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=dd352302-e2fe-4388-b4b0-00b34f6ebe48