United States· US:60505-3615_4fb749d9-409f-d07a-7006-394063557043
VARENICLINE
A medicinal product, registered in United States by Apotex Corp.
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
- Apotex Corp
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 20, 2026
Packs & prices · 2
- ndc1160505-3615-4
- ndc1160505361541 KIT in 1 CARTON (60505-3615-4) * 11 TABLET, FILM COATED in 1 BLISTER PACK (60505-3606-1) * 42 TABLET, FILM COATED in 1 BLISTER PACK (60505-3607-1)
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/c9a425af-7881-4c35-9c0e-fbb49b29afba GET /v1/drugs/c9a425af-7881-4c35-9c0e-fbb49b29afba?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": null,
"substance": null,
"productndc": "60505-3615",
"dosage_form": "KIT",
"dea_schedule": null,
"strength_unit": null,
"application_number": "ANDA201962",
"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.