pulmicort flexhaler

Generic: budesonide

Labeler: h2-pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name pulmicort flexhaler
Generic Name budesonide
Labeler h2-pharma llc
Dosage Form AEROSOL, POWDER
Routes
RESPIRATORY (INHALATION)
Active Ingredients

budesonide 90 ug/1

Manufacturer
H2-Pharma LLC

Identifiers & Regulatory

Product NDC 61269-509
Product ID 61269-509_f6ce08aa-a011-4120-a609-d542a4db8c15
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021949
Listing Expiration 2026-12-31
Marketing Start 2007-03-19

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 61269509
Hyphenated Format 61269-509

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 (61269-509-06) / 60 AEROSOL, POWDER in 1 INHALER
source: ndc

Packages (1)

61269-509-06 1 INHALER in 1 CARTON (61269-509-06) / 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": "f6ce08aa-a011-4120-a609-d542a4db8c15", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["Q3OKS62Q6X"], "rxcui": ["966522", "966524", "966527", "966529"], "spl_set_id": ["10f2ae5b-a6fb-4804-9111-0cd067c2b1b2"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["H2-Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 INHALER in 1 CARTON (61269-509-06)  / 60 AEROSOL, POWDER in 1 INHALER", "package_ndc": "61269-509-06", "marketing_start_date": "20070319"}], "brand_name": "PULMICORT FLEXHALER", "product_id": "61269-509_f6ce08aa-a011-4120-a609-d542a4db8c15", "dosage_form": "AEROSOL, POWDER", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "61269-509", "generic_name": "Budesonide", "labeler_name": "H2-Pharma LLC", "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": "20070319", "listing_expiration_date": "20261231"}