budesonide

Generic: budesonide

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name budesonide
Generic Name budesonide
Labeler a-s medication solutions
Dosage Form SUSPENSION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

budesonide .25 mg/2mL

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-6590
Product ID 50090-6590_603b6f9a-a2ea-46b1-9ed1-c5fa6cb97507
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211922
Listing Expiration 2026-12-31
Marketing Start 2021-05-01

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 500906590
Hyphenated Format 50090-6590

Supplemental Identifiers

RxCUI
349094
UNII
Q3OKS62Q6X
NUI
N0000175576 N0000175450

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 budesonide (source: ndc)
Generic Name budesonide (source: ndc)
Application Number ANDA211922 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • .25 mg/2mL
source: ndc
Packaging
  • 6 POUCH in 1 CARTON (50090-6590-0) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE
source: ndc

Packages (1)

50090-6590-0 6 POUCH in 1 CARTON (50090-6590-0) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE

Ingredients (1)

budesonide (.25 mg/2mL)

Linked Drug Pages (1)

Budesonide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "603b6f9a-a2ea-46b1-9ed1-c5fa6cb97507", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["Q3OKS62Q6X"], "rxcui": ["349094"], "spl_set_id": ["d406759d-4c02-4fc0-b513-56b303afca98"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "6 POUCH in 1 CARTON (50090-6590-0)  / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE", "package_ndc": "50090-6590-0", "marketing_start_date": "20230814"}], "brand_name": "Budesonide", "product_id": "50090-6590_603b6f9a-a2ea-46b1-9ed1-c5fa6cb97507", "dosage_form": "SUSPENSION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "50090-6590", "generic_name": "Budesonide", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Budesonide", "active_ingredients": [{"name": "BUDESONIDE", "strength": ".25 mg/2mL"}], "application_number": "ANDA211922", "marketing_category": "ANDA", "marketing_start_date": "20210501", "listing_expiration_date": "20261231"}