budesonide

Generic: budesonide

Labeler: rugby laboratories
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name budesonide
Generic Name budesonide
Labeler rugby laboratories
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

budesonide 32 ug/1

Manufacturer
Rugby Laboratories

Identifiers & Regulatory

Product NDC 0536-1112
Product ID 0536-1112_ce26c1bb-c50d-7731-6877-0b8a5fda98df
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA078949
Marketing Start 2016-07-27
Marketing End 2027-06-30

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 05361112
Hyphenated Format 0536-1112

Supplemental Identifiers

RxCUI
1797929
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 ANDA078949 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 32 ug/1
source: ndc
Packaging
  • 1 BOTTLE, SPRAY in 1 CARTON (0536-1112-48) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
source: ndc

Packages (1)

0536-1112-48 1 BOTTLE, SPRAY in 1 CARTON (0536-1112-48) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY

Ingredients (1)

budesonide (32 ug/1)

Linked Drug Pages (1)

Budesonide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "ce26c1bb-c50d-7731-6877-0b8a5fda98df", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["Q3OKS62Q6X"], "rxcui": ["1797929"], "spl_set_id": ["04eb9e98-1323-353f-3fd7-2d317dfac526"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Rugby Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, SPRAY in 1 CARTON (0536-1112-48)  / 120 SPRAY, METERED in 1 BOTTLE, SPRAY", "package_ndc": "0536-1112-48", "marketing_end_date": "20270630", "marketing_start_date": "20160727"}], "brand_name": "Budesonide", "product_id": "0536-1112_ce26c1bb-c50d-7731-6877-0b8a5fda98df", "dosage_form": "SPRAY, METERED", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0536-1112", "generic_name": "Budesonide", "labeler_name": "Rugby Laboratories", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Budesonide", "active_ingredients": [{"name": "BUDESONIDE", "strength": "32 ug/1"}], "application_number": "ANDA078949", "marketing_category": "ANDA", "marketing_end_date": "20270630", "marketing_start_date": "20160727"}