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United States· US:27241-187_1c32f27d-6637-481f-9df9-9ef064fd86e4

Varenicline

A medicinal product containing varenicline tartrate, registered in United States by Ajanta Pharma USA Inc..

Orange BookUS 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…normalisedVareniclineATC—REGISTER NO.US:27241-187_1c32f27d…PACKS LISTED1CHECKEDSeptember 12, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about varenicline tartrateAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
Varenicline tartrate
Manufacturer
Ajanta Pharma USA Inc.
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 12, 2026

Packs & prices · 1

  • ndc11
    2724118757
    1 KIT in 1 CARTON (27241-187-57) * 42 TABLET, FILM COATED in 1 BLISTER PACK * 11 TABLET, FILM COATED in 1 BLISTER PACK

Regulatory notes

Orange Book
A213019
ABAB
DailyMed SPL labels
1 version tracked

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/bb8e3a80-84fe-45d0-81ba-e4fe2ba97002
GET /v1/drugs/bb8e3a80-84fe-45d0-81ba-e4fe2ba97002?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,
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 3
  },
  "spl_meta": {
    "9e5c0ef3-3179-4d7b-bc76-901473c73ce8": {
      "match": "brand_token",
      "title": "VARENICLINE (VARENICLINE TARTRATE) TABLET, FILM COATED VARENICLINE (VARENICLINE TARTRATE) KIT [PAR HEALTH USA, LLC]",
      "spl_version": "23",
      "published_date": "2026-05-14"
    }
  },
  "productid": "27241-187_1c32f27d-6637-481f-9df9-9ef064fd86e4",
  "productndc": "27241-187",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "213019",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.5MG BASE",
        "product_no": "001",
        "approval_date": "Mar 19, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "002",
        "approval_date": "Mar 19, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Varenicline",
  "active_ingred_unit": null,
  "application_number": "ANDA213019",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Varenicline tartrate",
  "start_marketing_date": "20240131",
  "active_numerator_strength": null
}
API referenceMCP serverPlans

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.

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