VARENICLINE

Orange BookUNIISPLATC N07BA03

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

Identification

ManufacturerUmedica Laboratories USA Inc.

CountryUS (United States)

ATC codeN07BA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6029007701
56 TABLET in 1 BOTTLE (60290-077-01)
ndc11
6029007702
60 BLISTER PACK in 1 CARTON (60290-077-02) / 1 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

82269ASB48

VARENICLINE TARTRATE

RxCUI 636674

Orange Book

A218985

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": "60290-077_48e02d69-578d-6c15-e063-6394a90ade7c",
  "productndc": "60290-077",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "218985",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.5MG BASE",
        "product_no": "001",
        "approval_date": "Jan 9, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "002",
        "approval_date": "Jan 9, 2026"
      }
    ],
    "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": "ANDA218985",
  "marketing_category": "ANDA",
  "nonproprietary_name": "VARENICLINE",
  "start_marketing_date": "20260109",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code N07BA03.

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