United States· US:68682-658_cfc0acf9-28d8-4404-81ec-c832914d2ea6
budesonide
A medicinal product containing budesonide, registered in United States by Oceanside Pharmaceuticals.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- BUDESONIDE
- Manufacturer
- Oceanside Pharmaceuticals
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc1168682-658-03
- ndc1168682658032 CANISTER in 1 CARTON (68682-658-03) / 1 AEROSOL, FOAM in 1 CANISTER (68682-658-02)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Budesonide in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- NetherlandsBudenofalk Schuim 2 mg, schuim voor rectaal gebruikDr. Falk Pharma Benelux B.V.
- SwitzerlandBudenofalk
- CanadaUCERISBAUSCH HEALTH, CANADA INC.
- PolandBudenofalkDr. Falk Pharma GmbH
- United KingdomBudenofalk 2mg/application foam enemaDr. Falk Pharma UK Ltd
- SpainINTESTIFALK 2 mg/DOSIS ESPUMA RECTALDr. Falk Pharma Gmbh
- FinlandBudenofalkDr. Falk Pharma GmbH
- SwedenBudaxiro 3 mg Kapsel med modifierad frisättning, hårdMedical Valley Invest AB
Authorised across Europe · EMA
The same active substance is authorised in 31 EEA countries. Names it is sold under:
- Austria · Budenofalk, Budo-San
- Belgium · Budenofalk, Budesonid Sandoz
- Bulgaria · Airbudenid, Буденофалк
- Cyprus · Axelovert, Biosonide
- Czechia · Budenofalk, Budenofalk Uno
- Germany · Aquacort, Budapp Nasal
- Denmark · Benarhin, Budenofalk
- Estonia · Budesonid Sandoz, Budesonide
- Spain · Budena, Budesonida
- Finland · Budenofalk, Budesonid Easyhaler Orion
- France · Budésonide Arrow, Budesonide Biogaran
- United Kingdom (Northern Ireland) · Benacort, Benacort Hayfever Relief For Adults
- Greece · Aurid, Axelovert
- Croatia · Budelin Novolizer, Budosan
- Hungary · Budenofalk, Budesonid Easyhaler
- Ireland · Budenofalk, Budesonide Azure
- Iceland · Budesonide Stada, Cortiment
- Italy · Aircort, Bidien
- Liechtenstein · Jorveza, Kinpeygo
- Lithuania · Budenofalk, Budesonide Ferring
- Luxembourg · Budenofalk, Budesonide Eg
- Latvia · Budenofalk, Budesonid Sandoz
- Malta · Budesonida Aldo-Unión, Budesonide Azure
- Netherlands · Budenofalk, Budenofalk Schuim
- Norway · Budenofalk, Budesonid Medical Valley
- Poland · Bds N, Benodil
- Portugal · Aeromax, Budenofalk
- Romania · Budenofalk, Budenofalk Uno
- Sweden · Budaxiro, Budenofalk
- Slovenia · Budenofalk, Budesonid Easyhaler Orion
- Slovakia · Budelin Novolizer, Budenofalk
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/3d0b7b98-5bd3-4c07-bb49-ac210f169841 GET /v1/drugs/3d0b7b98-5bd3-4c07-bb49-ac210f169841?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "RECTAL",
"source": "ndc",
"strength": "2",
"substance": "BUDESONIDE",
"productndc": "68682-658",
"dosage_form": "AEROSOL, FOAM",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "NDA205613",
"marketing_category": "NDA"
}See everything about budesonide.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.