United States· US:72162-2231_baa76dde-3c5b-4ff4-ba0c-f19660a796c1

Mesalamine

A medicinal product containing mesalamine, registered in United States by Bryant Ranch Prepack.

US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedMesalamineATC—REGISTER NO.US:72162-2231_baa76dd…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
MESALAMINE
Manufacturer
Bryant Ranch Prepack
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

  • ndc11
    7216222312
    120 TABLET, DELAYED RELEASE in 1 BOTTLE (72162-2231-2)
  • ndc11
    72162-2231-2

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.

All mesalamine products

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/dac887e6-5e51-424e-a55f-6b6efdb8ab92
GET /v1/drugs/dac887e6-5e51-424e-a55f-6b6efdb8ab92?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": "1.2",
  "substance": "MESALAMINE",
  "productndc": "72162-2231",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "dea_schedule": null,
  "strength_unit": "g/1",
  "application_number": "ANDA203817",
  "marketing_category": "ANDA"
}

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.