VARENICLINE TARTRATE

Orange BookSPL

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

Identification

ManufacturerLupin Pharmaceuticals, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7074812513
1 BLISTER PACK in 1 CARTON (70748-125-13) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

A211862

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "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": "70748-125_3647a217-0da1-4778-adea-08d19a9c446f",
  "productndc": "70748-125",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "211862",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.5MG BASE",
        "product_no": "001",
        "approval_date": "Dec 4, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "002",
        "approval_date": "Dec 4, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "VARENICLINE TARTRATE",
  "active_ingred_unit": null,
  "application_number": "ANDA211862",
  "marketing_category": "ANDA",
  "nonproprietary_name": "VARENICLINE TARTRATE",
  "start_marketing_date": "20240320",
  "active_numerator_strength": null
}

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