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United States · US · US:69315-404_cd15d74e-92d3-4bf0-8c76-a01f9190b172
VARENICLINE TARTRATE
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLeading Pharma, LLC
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1169315404571 KIT in 1 BOX (69315-404-57) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
Orange Book
A217151
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": "69315-404_cd15d74e-92d3-4bf0-8c76-a01f9190b172",
"productndc": "69315-404",
"dosage_form": "KIT",
"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": null,
"proprietary_name": "VARENICLINE TARTRATE",
"active_ingred_unit": null,
"application_number": "ANDA217151",
"marketing_category": "ANDA",
"nonproprietary_name": "VARENICLINE TARTRATE",
"start_marketing_date": "20231001",
"active_numerator_strength": null
}Access this data programmatically
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