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United States · US · US:14445-155_97b537d2-8829-42ad-86e9-8523b4430843
Varenicline
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerIndoco Remedies Limited
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1114445155011 KIT in 1 CARTON (14445-155-01) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
Orange Book
A219106
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": "14445-155_97b537d2-8829-42ad-86e9-8523b4430843",
"productndc": "14445-155",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "219106",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 0.5MG BASE",
"product_no": "001",
"approval_date": "Oct 29, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 1MG BASE",
"product_no": "002",
"approval_date": "Oct 29, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Varenicline",
"active_ingred_unit": null,
"application_number": "ANDA219106",
"marketing_category": "ANDA",
"nonproprietary_name": "Varenicline Tartrate",
"start_marketing_date": "20241101",
"active_numerator_strength": null
}Access this data programmatically
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