United States· US:57841-1150_0649301c-fc4e-42a4-a62d-9a023a3f9f98

Talicia

A omeprazole, amoxicillin and rifabutin product containing omeprazole magnesium; amoxicillin; rifabutin, registered in United States by RedHill Biopharma Ltd.

ATC A02BD16US 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…normalisedTaliciaATCA02BD16REGISTER NO.US:57841-1150_0649301…PACKS LISTED4CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
OMEPRAZOLE MAGNESIUM; AMOXICILLIN; RIFABUTIN
Manufacturer
RedHill Biopharma Ltd
Country
United States (US)
ATC code
A02BD16
ATC class
Omeprazole, amoxicillin and rifabutin
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 4

  • ndc11
    5784111502
    2 BOTTLE in 1 CARTON (57841-1150-2) / 84 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57841-1150-1)
  • ndc11
    5784111504
    2 BOTTLE in 1 CARTON (57841-1150-4) / 84 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57841-1150-3)
  • ndc11
    57841-1150-2
  • ndc11
    57841-1150-4

Regulatory notes

No shortage, Orange Book or US label notes for this record.

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/b55e6fee-4aea-4ff5-9bdf-0a6583d85d2a
GET /v1/drugs/b55e6fee-4aea-4ff5-9bdf-0a6583d85d2a?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": "10; 250; 12.5",
  "substance": "OMEPRAZOLE MAGNESIUM; AMOXICILLIN; RIFABUTIN",
  "productndc": "57841-1150",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "dea_schedule": null,
  "strength_unit": "mg/1; mg/1; mg/1",
  "application_number": "NDA213004",
  "marketing_category": "NDA"
}

See everything about omeprazole, amoxicillin and rifabutin.

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.