United States· US:69315-404_cd15d74e-92d3-4bf0-8c76-a01f9190b172
VARENICLINE TARTRATE
A medicinal product, registered in United States by Leading Pharma, LLC.
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)- Manufacturer
- Leading Pharma, LLC
- 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
- ndc1169315-404-57
- ndc1169315404571 KIT in 1 BOX (69315-404-57) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK
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/fa918ac4-b9ff-4ff5-9615-dfdda2c39152 GET /v1/drugs/fa918ac4-b9ff-4ff5-9615-dfdda2c39152?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": null,
"source": "ndc",
"strength": null,
"substance": null,
"productndc": "69315-404",
"dosage_form": "KIT",
"dea_schedule": null,
"strength_unit": null,
"application_number": "ANDA217151",
"marketing_category": "ANDA"
}See everything about VARENICLINE.
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.