budesonide

Generic: budesonide

Labeler: oceanside pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name budesonide
Generic Name budesonide
Labeler oceanside pharmaceuticals
Dosage Form AEROSOL, FOAM
Routes
RECTAL
Active Ingredients

budesonide 2 mg/1

Manufacturer
Oceanside Pharmaceuticals

Identifiers & Regulatory

Product NDC 68682-658
Product ID 68682-658_cfc0acf9-28d8-4404-81ec-c832914d2ea6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205613
Listing Expiration 2026-12-31
Marketing Start 2022-07-15

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 68682658
Hyphenated Format 68682-658

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 NDA205613 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 2 CANISTER in 1 CARTON (68682-658-03) / 1 AEROSOL, FOAM in 1 CANISTER (68682-658-02)
source: ndc

Packages (1)

68682-658-03 2 CANISTER in 1 CARTON (68682-658-03) / 1 AEROSOL, FOAM in 1 CANISTER (68682-658-02)

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": "cfc0acf9-28d8-4404-81ec-c832914d2ea6", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["Q3OKS62Q6X"], "rxcui": ["1596779"], "spl_set_id": ["b2cf85c5-3ae0-4f91-9f3a-1d6771e14a73"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Oceanside Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 CANISTER in 1 CARTON (68682-658-03)  / 1 AEROSOL, FOAM in 1 CANISTER (68682-658-02)", "package_ndc": "68682-658-03", "marketing_start_date": "20220715"}], "brand_name": "budesonide", "product_id": "68682-658_cfc0acf9-28d8-4404-81ec-c832914d2ea6", "dosage_form": "AEROSOL, FOAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68682-658", "generic_name": "budesonide", "labeler_name": "Oceanside Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "budesonide", "active_ingredients": [{"name": "BUDESONIDE", "strength": "2 mg/1"}], "application_number": "NDA205613", "marketing_category": "NDA", "marketing_start_date": "20220715", "listing_expiration_date": "20261231"}