pulmicort flexhaler

Generic: budesonide

Labeler: rubicon holdings inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name pulmicort flexhaler
Generic Name budesonide
Labeler rubicon holdings inc.
Dosage Form AEROSOL, POWDER
Routes
RESPIRATORY (INHALATION)
Active Ingredients

budesonide 90 ug/1

Manufacturer
Rubicon Holdings Inc.

Identifiers & Regulatory

Product NDC 85612-010
Product ID 85612-010_a035bb8f-2fe9-4a86-af53-32196ffc0361
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021949
Listing Expiration 2026-12-31
Marketing Start 2025-07-01

Pharmacologic Class

Established (EPC)
corticosteroid [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 85612010
Hyphenated Format 85612-010

Supplemental Identifiers

RxCUI
966522 966524 966527 966529
UNII
Q3OKS62Q6X
NUI
N0000175576 N0000175450

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name pulmicort flexhaler (source: ndc)
Generic Name budesonide (source: ndc)
Application Number NDA021949 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 90 ug/1
source: ndc
Packaging
  • 1 INHALER in 1 CARTON (85612-010-01) / 60 AEROSOL, POWDER in 1 INHALER
source: ndc

Packages (1)

85612-010-01 1 INHALER in 1 CARTON (85612-010-01) / 60 AEROSOL, POWDER in 1 INHALER

Ingredients (1)

budesonide (90 ug/1)

Linked Drug Pages (1)

PULMICORT FLEXHALER ndc-match (0.9)

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 (85612-010-01)  / 60 AEROSOL, POWDER in 1 INHALER", "package_ndc": "85612-010-01", "marketing_start_date": "20250701"}], "brand_name": "PULMICORT FLEXHALER", "product_id": "85612-010_a035bb8f-2fe9-4a86-af53-32196ffc0361", "dosage_form": "AEROSOL, POWDER", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "85612-010", "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": "90 ug/1"}], "application_number": "NDA021949", "marketing_category": "NDA", "marketing_start_date": "20250701", "listing_expiration_date": "20261231"}