Package 59651-801-20

Brand: roflumilast

Generic: roflumilast
NDC Package

Package Facts

Identity

Package NDC 59651-801-20
Digits Only 5965180120
Product NDC 59651-801
Description

1 BLISTER PACK in 1 CARTON (59651-801-20) / 20 TABLET in 1 BLISTER PACK

Marketing

Marketing Status
Marketed Since 2025-01-31
Brand roflumilast
Generic roflumilast
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "586e58c7-172f-4c3f-a91f-045ea4d089fc", "openfda": {"nui": ["N0000182961", "N0000182960"], "unii": ["0P6C6ZOP5U"], "rxcui": ["1091839", "2001319"], "spl_set_id": ["7cb11d48-6bb9-437b-bc7f-382050a2d3e6"], "pharm_class_epc": ["Phosphodiesterase 4 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 4 Inhibitors [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (59651-801-20)  / 20 TABLET in 1 BLISTER PACK", "package_ndc": "59651-801-20", "marketing_start_date": "20250131"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (59651-801-28)  / 28 TABLET in 1 BLISTER PACK", "package_ndc": "59651-801-28", "marketing_start_date": "20250131"}], "brand_name": "ROFLUMILAST", "product_id": "59651-801_586e58c7-172f-4c3f-a91f-045ea4d089fc", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 4 Inhibitor [EPC]", "Phosphodiesterase 4 Inhibitors [MoA]"], "product_ndc": "59651-801", "generic_name": "ROFLUMILAST", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ROFLUMILAST", "active_ingredients": [{"name": "ROFLUMILAST", "strength": "250 ug/1"}], "application_number": "ANDA213298", "marketing_category": "ANDA", "marketing_start_date": "20250131", "listing_expiration_date": "20261231"}