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United States · US · US:0904-7415_1297c291-da28-4a73-9c28-d5adee36d7b7
Varenicline
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMajor Pharmaceuticals
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1109047415161 KIT in 1 CARTON (0904-7415-16) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
Orange Book
A214557
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": "0904-7415_1297c291-da28-4a73-9c28-d5adee36d7b7",
"productndc": "0904-7415",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "214557",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 0.5MG BASE",
"product_no": "001",
"approval_date": "Aug 23, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 1MG BASE",
"product_no": "002",
"approval_date": "Aug 23, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Varenicline",
"active_ingred_unit": null,
"application_number": "ANDA214557",
"marketing_category": "ANDA",
"nonproprietary_name": "Varenicline tartrate",
"start_marketing_date": "20231218",
"active_numerator_strength": null
}Access this data programmatically
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