# ROFLUMILAST

NDC: 59651-801
Generic name: ROFLUMILAST
Labeler / Manufacturer: Aurobindo Pharma Limited
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: Abbreviated NDA (generic)
Dosage form: TABLET
Routes: ORAL
Marketing started: 20250131

FDA application: ANDA213298

## Active ingredients

- ROFLUMILAST: 250 ug/1

## Pharmacological class

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## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"59651-801"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=59651-801
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7cb11d48-6bb9-437b-bc7f-382050a2d3e6