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United States · US · US:27241-187_1c32f27d-6637-481f-9df9-9ef064fd86e4
Varenicline
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAjanta Pharma USA Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1127241187571 KIT in 1 CARTON (27241-187-57) * 42 TABLET, FILM COATED in 1 BLISTER PACK * 11 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
Orange Book
A213019
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": "27241-187_1c32f27d-6637-481f-9df9-9ef064fd86e4",
"productndc": "27241-187",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "213019",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 0.5MG BASE",
"product_no": "001",
"approval_date": "Mar 19, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 1MG BASE",
"product_no": "002",
"approval_date": "Mar 19, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Varenicline",
"active_ingred_unit": null,
"application_number": "ANDA213019",
"marketing_category": "ANDA",
"nonproprietary_name": "Varenicline tartrate",
"start_marketing_date": "20240131",
"active_numerator_strength": null
}Access this data programmatically
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