Package 85612-011-01

Brand: pulmicort flexhaler

Generic: budesonide
NDC Package

Package Facts

Identity

Package NDC 85612-011-01
Digits Only 8561201101
Product NDC 85612-011
Description

1 INHALER in 1 CARTON (85612-011-01) / 120 AEROSOL, POWDER in 1 INHALER

Marketing

Marketing Status
Marketed Since 2025-07-01
Brand pulmicort flexhaler
Generic budesonide
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "a035bb8f-2fe9-4a86-af53-32196ffc0361", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["Q3OKS62Q6X"], "rxcui": ["966522", "966524", "966527", "966529"], "spl_set_id": ["ae1105cd-69fc-4c15-937f-c535304341c2"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Rubicon Holdings Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 INHALER in 1 CARTON (85612-011-01)  / 120 AEROSOL, POWDER in 1 INHALER", "package_ndc": "85612-011-01", "marketing_start_date": "20250701"}], "brand_name": "PULMICORT FLEXHALER", "product_id": "85612-011_a035bb8f-2fe9-4a86-af53-32196ffc0361", "dosage_form": "AEROSOL, POWDER", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "85612-011", "generic_name": "Budesonide", "labeler_name": "Rubicon Holdings Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PULMICORT", "brand_name_suffix": "FLEXHALER", "active_ingredients": [{"name": "BUDESONIDE", "strength": "180 ug/1"}], "application_number": "NDA021949", "marketing_category": "NDA", "marketing_start_date": "20250701", "listing_expiration_date": "20261231"}