United States· US:73521-030_b8c6f558-9cbd-4389-a8d7-a8c698c49093

Tyrvaya

A medicinal product containing varenicline tartrate, registered in United States by Oyster Point Pharma, Inc..

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…normalisedTyrvayaATC—REGISTER NO.US:73521-030_b8c6f558…PACKS LISTED4CHECKEDAugust 23, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
VARENICLINE TARTRATE
Manufacturer
Oyster Point Pharma, Inc.
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
August 23, 2026

Packs & prices · 4

  • ndc11
    7352103002
    2 BOTTLE, PUMP in 1 CARTON (73521-030-02) / 4.2 mL in 1 BOTTLE, PUMP
  • ndc11
    7352103090
    1 BOTTLE, PUMP in 1 CARTON (73521-030-90) / 4.2 mL in 1 BOTTLE, PUMP
  • ndc11
    73521-030-02
  • ndc11
    73521-030-90

Regulatory notes

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

Same medicine, other countries

Varenicline tartrate in 17 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All varenicline tartrate products

Authorised across Europe · EMA

The same active substance is authorised in 19 EEA countries. Names it is sold under:

  • Austria · Civarenix, Civarenix Starterpackung
  • Belgium · Varenicline Ab, Varenicline Eg
  • Czechia · Civarenix, Varenicline Glenmark
  • Germany · Vareniclin Ascend, Vareniclin Axunio
  • Denmark · Civarenix, Vareniclin Axunio
  • Spain · Byteqi, Cuitvar
  • Finland · Varenicline Glenmark, Varenicline Orion
  • France · Varenicline, Varenicline Arrow
  • United Kingdom (Northern Ireland) · Varenicline, Varenicline Accord
  • Ireland · Varenicline Ascend, Varenicline Teva
  • Iceland · Champix, Vareniclin Normon
  • Italy · Civarenix, Vareniclina Aurobindo
  • Liechtenstein · Champix
  • Luxembourg · Vareniclin Ratiopharm, Vareniclin Starterpackung Ratiopharm
  • Malta · Varenicline Glenmark
  • Netherlands · Byteqi, Cuitvar
  • Norway · Champix, Varenicline Bluefish
  • Portugal · Cuitvar, Exchampra
  • Sweden · Civarenix, Varenicline Bluefish

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/748d4abe-d95b-48d3-afb3-3831f3f069ce
GET /v1/drugs/748d4abe-d95b-48d3-afb3-3831f3f069ce?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": "NASAL",
  "source": "ndc",
  "strength": ".03",
  "substance": "VARENICLINE TARTRATE",
  "productndc": "73521-030",
  "dosage_form": "SPRAY",
  "dea_schedule": null,
  "strength_unit": "mg/.05mL",
  "application_number": "NDA213978",
  "marketing_category": "NDA"
}

See everything about varenicline tartrate.

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.