VARENICLINE TARTRATE

Orange BookUNIISPLATC N07BA03

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

Identification

ManufacturerKanchan Healthcare Inc

CountryUS (United States)

ATC codeN07BA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
8574201615
56 TABLET, FILM COATED in 1 BOTTLE (85742-016-15)
ndc11
8574201616
1 BLISTER PACK in 1 BOX (85742-016-16) / 56 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

82269ASB48

VARENICLINE TARTRATE

RxCUI 636674

Orange Book

A217151

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": "85742-016_bfc03c5c-16ca-4b83-af77-a9c539b87813",
  "productndc": "85742-016",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "217151",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.5MG BASE",
        "product_no": "001",
        "approval_date": "Jul 25, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "002",
        "approval_date": "Jul 25, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VARENICLINE TARTRATE",
  "proprietary_name": "VARENICLINE TARTRATE",
  "active_ingred_unit": "mg/561",
  "application_number": "ANDA217151",
  "marketing_category": "ANDA",
  "nonproprietary_name": "VARENICLINE TARTRATE",
  "start_marketing_date": "20231001",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code N07BA03.

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