Package 43547-005-03

Brand: roflumilast

Generic: roflumilast
NDC Package

Package Facts

Identity

Package NDC 43547-005-03
Digits Only 4354700503
Product NDC 43547-005
Description

30 TABLET in 1 BOTTLE (43547-005-03)

Marketing

Marketing Status
Marketed Since 2022-05-10
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": "4251c764-7224-4f94-9de7-b6c76cb1f5cd", "openfda": {"nui": ["N0000182961", "N0000182960"], "unii": ["0P6C6ZOP5U"], "rxcui": ["1091839"], "spl_set_id": ["4251c764-7224-4f94-9de7-b6c76cb1f5cd"], "pharm_class_epc": ["Phosphodiesterase 4 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 4 Inhibitors [MoA]"], "manufacturer_name": ["Solco Healthcare US, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (43547-005-03)", "package_ndc": "43547-005-03", "marketing_start_date": "20220510"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (43547-005-09)", "package_ndc": "43547-005-09", "marketing_start_date": "20220510"}], "brand_name": "ROFLUMILAST", "product_id": "43547-005_4251c764-7224-4f94-9de7-b6c76cb1f5cd", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 4 Inhibitor [EPC]", "Phosphodiesterase 4 Inhibitors [MoA]"], "product_ndc": "43547-005", "generic_name": "roflumilast", "labeler_name": "Solco Healthcare US, LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ROFLUMILAST", "active_ingredients": [{"name": "ROFLUMILAST", "strength": "500 ug/1"}], "application_number": "ANDA208299", "marketing_category": "ANDA", "marketing_start_date": "20220510", "listing_expiration_date": "20261231"}