pulmicort respules

Generic: budesonide

Labeler: astrazeneca pharmaceuticals lp
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name pulmicort respules
Generic Name budesonide
Labeler astrazeneca pharmaceuticals lp
Dosage Form SUSPENSION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

budesonide 1 mg/2mL

Manufacturer
AstraZeneca Pharmaceuticals LP

Identifiers & Regulatory

Product NDC 0186-1990
Product ID 0186-1990_76a8044c-b6f4-4da4-b855-a281fdca66b4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020929
Listing Expiration 2026-12-31
Marketing Start 2007-09-17

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 01861990
Hyphenated Format 0186-1990

Supplemental Identifiers

RxCUI
252559 349094 351109 616817 616819 616830
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 respules (source: ndc)
Generic Name budesonide (source: ndc)
Application Number NDA020929 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 1 mg/2mL
source: ndc
Packaging
  • 6 POUCH in 1 CARTON (0186-1990-04) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE
source: ndc

Packages (1)

0186-1990-04 6 POUCH in 1 CARTON (0186-1990-04) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE

Ingredients (1)

budesonide (1 mg/2mL)

Linked Drug Pages (1)

PULMICORT RESPULES ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "76a8044c-b6f4-4da4-b855-a281fdca66b4", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["Q3OKS62Q6X"], "rxcui": ["252559", "349094", "351109", "616817", "616819", "616830"], "spl_set_id": ["33cd9834-76df-4f26-3fa2-aab6b9eee8f2"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["AstraZeneca Pharmaceuticals LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 POUCH in 1 CARTON (0186-1990-04)  / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE", "package_ndc": "0186-1990-04", "marketing_start_date": "20070917"}], "brand_name": "PULMICORT RESPULES", "product_id": "0186-1990_76a8044c-b6f4-4da4-b855-a281fdca66b4", "dosage_form": "SUSPENSION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0186-1990", "generic_name": "Budesonide", "labeler_name": "AstraZeneca Pharmaceuticals LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PULMICORT RESPULES", "active_ingredients": [{"name": "BUDESONIDE", "strength": "1 mg/2mL"}], "application_number": "NDA020929", "marketing_category": "NDA", "marketing_start_date": "20070917", "listing_expiration_date": "20261231"}