VARENICLINE

Orange BookUNIISPLATC N07BA03

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeN07BA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009064460
56 TABLET, FILM COATED in 1 BOTTLE (50090-6446-0)

Annotations

UNII (FDA Substance ID)

82269ASB48

VARENICLINE TARTRATE

RxCUI 636674

Orange Book

A201962

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": "50090-6446_6fd1d19f-3d72-4c29-b97b-d5a11dbeeb0b",
  "productndc": "50090-6446",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "201962",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.5MG BASE",
        "product_no": "001",
        "approval_date": "Jan 25, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "002",
        "approval_date": "Jan 25, 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": "ANDA201962",
  "marketing_category": "ANDA",
  "nonproprietary_name": "VARENICLINE",
  "start_marketing_date": "20230126",
  "active_numerator_strength": "1"
}

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