FDA NDC Directory · JSON-LD · Markdown

ROFLUMILAST

NDC 59651-801 · HUMAN PRESCRIPTION DRUG · TABLET

Labeler / ManufacturerAurobindo Pharma Limited
Marketing categoryAbbreviated NDA (generic) · App ANDA213298
Dosage form / routeTABLET · ORAL
Active ingredientsROFLUMILAST (250 ug/1)
Marketing started20250131
Package count2

External sources

Source: openFDA. Public-domain (CC0).