budesonide

Generic: budesonide

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name budesonide
Generic Name budesonide
Labeler aurobindo pharma limited
Dosage Form SUSPENSION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

budesonide .5 mg/2mL

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-585
Product ID 59651-585_c70c734f-2431-4414-bb94-4adda4985e5d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216667
Listing Expiration 2026-12-31
Marketing Start 2023-11-29

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 59651585
Hyphenated Format 59651-585

Supplemental Identifiers

RxCUI
351109
UPC
0359651585054
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 budesonide (source: ndc)
Generic Name budesonide (source: ndc)
Application Number ANDA216667 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • .5 mg/2mL
source: ndc
Packaging
  • 6 POUCH in 1 CARTON (59651-585-30) / 5 AMPULE in 1 POUCH (59651-585-05) / 2 mL in 1 AMPULE
source: ndc

Packages (1)

59651-585-30 6 POUCH in 1 CARTON (59651-585-30) / 5 AMPULE in 1 POUCH (59651-585-05) / 2 mL in 1 AMPULE

Ingredients (1)

budesonide (.5 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": "c70c734f-2431-4414-bb94-4adda4985e5d", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0359651585054"], "unii": ["Q3OKS62Q6X"], "rxcui": ["351109"], "spl_set_id": ["c70c734f-2431-4414-bb94-4adda4985e5d"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 POUCH in 1 CARTON (59651-585-30)  / 5 AMPULE in 1 POUCH (59651-585-05)  / 2 mL in 1 AMPULE", "package_ndc": "59651-585-30", "marketing_start_date": "20231129"}], "brand_name": "BUDESONIDE", "product_id": "59651-585_c70c734f-2431-4414-bb94-4adda4985e5d", "dosage_form": "SUSPENSION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "59651-585", "generic_name": "BUDESONIDE", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BUDESONIDE", "active_ingredients": [{"name": "BUDESONIDE", "strength": ".5 mg/2mL"}], "application_number": "ANDA216667", "marketing_category": "ANDA", "marketing_start_date": "20231129", "listing_expiration_date": "20261231"}