United States· US:68682-113_0ce2b1db-0b45-4548-e063-6294a90a84f1
mesalamine
A medicinal product containing mesalamine, 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
- MESALAMINE
- 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
- ndc1168682113201 BOTTLE in 1 CARTON (68682-113-20) / 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
- ndc1168682-113-20
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Mesalamine in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomAsacol 1g/application foam enemaAllergan Ltd
- CzechiaASACOLTillotts Pharma GmbH, Rheinfelden
- NetherlandsAsacol 400 tablet, maagsapresistente tabletten 400 mgpharmaand GmbH
- SwedenAsacol 1 g RektalsuspensionTillotts Pharma AB
- ItalyARGONALDICOFARM S.P.A.
- SpainASACOL 1 G SUPOSITORIOSTillotts Pharma Spain S.L.U.
- IrelandAsacolon 1000 mg SuppositoryTillotts Pharma GmbH
- SwitzerlandAsacol
Authorised across Europe · EMA
The same active substance is authorised in 30 EEA countries. Names it is sold under:
- Austria · Azzavix, Claversal
- Belgium · Asamovon, Claversal
- Bulgaria · Salofalk – Салофалк, Пентаза
- Cyprus · Asacol, Mecolzine
- Czechia · Asacol, Asacol Enema
- Germany · Asacol, Claversal
- Denmark · Asacol, Mesalazin Orion
- Estonia · Asacol, Pentasa
- Spain · Asacol, Azzavix
- Finland · Asacol, Asacol 1 G
- France · Fivasa, Mazalvix
- United Kingdom (Northern Ireland) · Asacol, Mesalazine
- Greece · Asacol, Asalazin
- Croatia · Pentasa, Salofalk
- Hungary · Pentasa, Salofalk
- Ireland · Asacolon, Galtasa
- Iceland · Asacol, Pentasa
- Italy · Argonal, Asacol
- Lithuania · Asacol, Pentasa
- Luxembourg · Claversal, Claversal Foam
- Latvia · Asacol, Pentasa
- Malta · Mecolzine, Mezavant Xl
- Netherlands · Asacol, Azzavix
- Norway · Asacol, Mesalazin Orion
- Poland · Crohnax, Granmesa
- Portugal · Asacol, Azzavix
- Romania · Mesalazina Alfasigma, Pentasa
- Sweden · Asacol, Mesalazin Orion
- Slovenia · Asacol, Asacol®
- Slovakia · Pentasa, Pentasa Sachet
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/da1429e6-33b1-43d1-ad0e-0cc61d5916ce GET /v1/drugs/da1429e6-33b1-43d1-ad0e-0cc61d5916ce?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": "ORAL",
"source": "ndc",
"strength": "375",
"substance": "MESALAMINE",
"productndc": "68682-113",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "NDA022301",
"marketing_category": "NDA AUTHORIZED GENERIC"
}See everything about mesalamine.
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.