Package 42571-369-83

Brand: roflumilast

Generic: roflumilast
NDC Package

Package Facts

Identity

Package NDC 42571-369-83
Digits Only 4257136983
Product NDC 42571-369
Description

28 TABLET in 1 BOTTLE (42571-369-83)

Marketing

Marketing Status
Marketed Since 2023-05-01
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": "3aacb2a6-70a4-650d-e063-6394a90af9fc", "openfda": {"nui": ["N0000182961", "N0000182960"], "upc": ["0342571259327", "0342571369835", "0342571259303"], "unii": ["0P6C6ZOP5U"], "rxcui": ["1091839", "2001319"], "spl_set_id": ["dc2a689f-cfa4-4863-9623-a9813dcf86a9"], "pharm_class_epc": ["Phosphodiesterase 4 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 4 Inhibitors [MoA]"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (42571-369-05)", "package_ndc": "42571-369-05", "marketing_start_date": "20230501"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (42571-369-11)  / 10 TABLET in 1 BLISTER PACK (42571-369-32)", "package_ndc": "42571-369-11", "marketing_start_date": "20230501"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (42571-369-30)", "package_ndc": "42571-369-30", "marketing_start_date": "20230501"}, {"sample": false, "description": "28 TABLET in 1 BOTTLE (42571-369-83)", "package_ndc": "42571-369-83", "marketing_start_date": "20230501"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (42571-369-90)", "package_ndc": "42571-369-90", "marketing_start_date": "20230501"}], "brand_name": "ROFLUMILAST", "product_id": "42571-369_3aacb2a6-70a4-650d-e063-6394a90af9fc", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 4 Inhibitor [EPC]", "Phosphodiesterase 4 Inhibitors [MoA]"], "product_ndc": "42571-369", "generic_name": "ROFLUMILAST", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ROFLUMILAST", "active_ingredients": [{"name": "ROFLUMILAST", "strength": "250 ug/1"}], "application_number": "ANDA208180", "marketing_category": "ANDA", "marketing_start_date": "20230501", "listing_expiration_date": "20261231"}