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United States · US · US:75834-336_077ec752-4145-4592-9ee1-6fdc9a04795a
varenicline
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNivagen Pharmaceuticals Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1175834336242 BOX in 1 KIT (75834-336-24) / 1 KIT in 1 BOX * 1 BLISTER PACK in 1 BOX (75834-334-25) / 11 TABLET, FILM COATED in 1 BLISTER PACK * 3 BLISTER PACK in 1 BOX (75834-335-26) / 14 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
Orange Book
A217115
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": "75834-336_077ec752-4145-4592-9ee1-6fdc9a04795a",
"productndc": "75834-336",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "217115",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 0.5MG BASE",
"product_no": "001",
"approval_date": "Jul 23, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 1MG BASE",
"product_no": "002",
"approval_date": "Jul 23, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "varenicline",
"active_ingred_unit": null,
"application_number": "ANDA217115",
"marketing_category": "ANDA",
"nonproprietary_name": "varenicline",
"start_marketing_date": "20260302",
"active_numerator_strength": null
}Access this data programmatically
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