CHANTIX

{
  "unii": {
    "unii": "82269ASB48",
    "rxcui": "636674",
    "inchikey": "TWYFGYXQSYOKLK-CYUSMAIQSA-N",
    "display_name": "VARENICLINE TARTRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f0ff4f27-5185-4881-a749-c6b7a0ca5696": {
      "match": "brand_token",
      "title": "CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]",
      "spl_version": "49",
      "published_date": "2026-01-23"
    }
  },
  "productid": "0069-0468_09cce88b-e4f0-48b7-ac05-54d97976b4c5",
  "productndc": "0069-0468",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "021928",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "May 10, 2006"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "May 10, 2006"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VARENICLINE TARTRATE",
  "proprietary_name": "CHANTIX",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021928",
  "marketing_category": "NDA",
  "nonproprietary_name": "varenicline tartrate",
  "start_marketing_date": "20060510",
  "active_numerator_strength": ".5"
}