varenicline

Orange BookUNIISPLATC N07BA03

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerMajor Pharmaceuticals

CountryUS (United States)

ATC codeN07BA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0904741335
56 TABLET, FILM COATED in 1 BOTTLE (0904-7413-35)

Annotations

UNII (FDA Substance ID)

82269ASB48

VARENICLINE TARTRATE

RxCUI 636674

Orange Book

A214557

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "82269ASB48",
    "rxcui": "636674",
    "inchikey": "TWYFGYXQSYOKLK-CYUSMAIQSA-N",
    "display_name": "VARENICLINE TARTRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "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": "0904-7413_1297c291-da28-4a73-9c28-d5adee36d7b7",
  "productndc": "0904-7413",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "214557",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.5MG BASE",
        "product_no": "001",
        "approval_date": "Aug 23, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "002",
        "approval_date": "Aug 23, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VARENICLINE TARTRATE",
  "proprietary_name": "varenicline",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA214557",
  "marketing_category": "ANDA",
  "nonproprietary_name": "varenicline tartrate",
  "start_marketing_date": "20231218",
  "active_numerator_strength": ".5"
}

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