budesonide

Generic: budesonide

Labeler: apotex corp.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name budesonide
Generic Name budesonide
Labeler apotex corp.
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

budesonide 32 ug/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-6129
Product ID 60505-6129_df59479a-8980-e041-8936-c4fb5926ef88
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA078949
Listing Expiration 2026-12-31
Marketing Start 2016-04-19

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 605056129
Hyphenated Format 60505-6129

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 BOTTLE, SPRAY (60505-6129-2) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
  • 2 BOTTLE, SPRAY in 1 CARTON (60505-6129-6) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
  • 3 BOTTLE, SPRAY in 1 CARTON (60505-6129-7) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
source: ndc

Packages (3)

60505-6129-2 1 BOTTLE, SPRAY in 1 BOTTLE, SPRAY (60505-6129-2) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY 60505-6129-6 2 BOTTLE, SPRAY in 1 CARTON (60505-6129-6) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY 60505-6129-7 3 BOTTLE, SPRAY in 1 CARTON (60505-6129-7) / 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": "df59479a-8980-e041-8936-c4fb5926ef88", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["Q3OKS62Q6X"], "rxcui": ["1797929"], "spl_set_id": ["f1aac35a-bc72-dd68-8179-8661354589cb"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, SPRAY in 1 BOTTLE, SPRAY (60505-6129-2)  / 120 SPRAY, METERED in 1 BOTTLE, SPRAY", "package_ndc": "60505-6129-2", "marketing_start_date": "20160419"}, {"sample": false, "description": "2 BOTTLE, SPRAY in 1 CARTON (60505-6129-6)  / 120 SPRAY, METERED in 1 BOTTLE, SPRAY", "package_ndc": "60505-6129-6", "marketing_start_date": "20160419"}, {"sample": false, "description": "3 BOTTLE, SPRAY in 1 CARTON (60505-6129-7)  / 120 SPRAY, METERED in 1 BOTTLE, SPRAY", "package_ndc": "60505-6129-7", "marketing_start_date": "20160419"}], "brand_name": "Budesonide", "product_id": "60505-6129_df59479a-8980-e041-8936-c4fb5926ef88", "dosage_form": "SPRAY, METERED", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "60505-6129", "generic_name": "Budesonide", "labeler_name": "Apotex Corp.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Budesonide", "active_ingredients": [{"name": "BUDESONIDE", "strength": "32 ug/1"}], "application_number": "ANDA078949", "marketing_category": "ANDA", "marketing_start_date": "20160419", "listing_expiration_date": "20261231"}