budesonide

Generic: budesonide

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name budesonide
Generic Name budesonide
Labeler padagis israel pharmaceuticals ltd
Dosage Form AEROSOL, FOAM
Routes
RECTAL
Active Ingredients

budesonide 2 mg/1

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-627
Product ID 45802-627_ad4a68e7-9200-4f05-8058-714d5d8900f8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215328
Listing Expiration 2026-12-31
Marketing Start 2023-04-17

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 45802627
Hyphenated Format 45802-627

Supplemental Identifiers

RxCUI
1596779
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 ANDA215328 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 2 CANISTER in 1 CARTON (45802-627-86) / 1 AEROSOL, FOAM in 1 CANISTER (45802-627-01)
source: ndc

Packages (1)

45802-627-86 2 CANISTER in 1 CARTON (45802-627-86) / 1 AEROSOL, FOAM in 1 CANISTER (45802-627-01)

Ingredients (1)

budesonide (2 mg/1)

Linked Drug Pages (1)

BUDESONIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RECTAL"], "spl_id": "ad4a68e7-9200-4f05-8058-714d5d8900f8", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["Q3OKS62Q6X"], "rxcui": ["1596779"], "spl_set_id": ["ad4a68e7-9200-4f05-8058-714d5d8900f8"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 CANISTER in 1 CARTON (45802-627-86)  / 1 AEROSOL, FOAM in 1 CANISTER (45802-627-01)", "package_ndc": "45802-627-86", "marketing_start_date": "20230417"}], "brand_name": "BUDESONIDE", "product_id": "45802-627_ad4a68e7-9200-4f05-8058-714d5d8900f8", "dosage_form": "AEROSOL, FOAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "45802-627", "generic_name": "budesonide", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BUDESONIDE", "active_ingredients": [{"name": "BUDESONIDE", "strength": "2 mg/1"}], "application_number": "ANDA215328", "marketing_category": "ANDA", "marketing_start_date": "20230417", "listing_expiration_date": "20261231"}