# Roflumilast

NDC: 68382-624
Generic name: Roflumilast
Labeler / Manufacturer: Zydus Pharmaceuticals USA Inc.
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: Abbreviated NDA (generic)
Dosage form: TABLET
Routes: ORAL
Marketing started: 20230518

FDA application: ANDA208303

## 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:"68382-624"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=68382-624
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=84145572-f320-4c3f-ab29-bd9f6c18746c