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United States · US · US:68462-895_67a82933-5f10-4a9a-8605-d09cd2f08d52
varenicline tartrate
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168462895041 KIT in 1 CARTON (68462-895-04) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
Orange Book
A214255
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": "68462-895_67a82933-5f10-4a9a-8605-d09cd2f08d52",
"productndc": "68462-895",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "214255",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 0.5MG BASE",
"product_no": "001",
"approval_date": "Aug 1, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 1MG BASE",
"product_no": "002",
"approval_date": "Aug 1, 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": "ANDA214255",
"marketing_category": "ANDA",
"nonproprietary_name": "varenicline tartrate",
"start_marketing_date": "20230822",
"active_numerator_strength": null
}Access this data programmatically
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