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United States · US · US:31722-690_09a2708f-ed1b-b986-e063-6394a90a8fb5
Varenicline
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCamber Pharmaceuticals, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1131722690311 KIT in 1 CARTON (31722-690-31) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
Orange Book
A214571
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": "31722-690_09a2708f-ed1b-b986-e063-6394a90a8fb5",
"productndc": "31722-690",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "214571",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 0.5MG BASE",
"product_no": "001",
"approval_date": "Oct 23, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 1MG BASE",
"product_no": "002",
"approval_date": "Oct 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": "ANDA214571",
"marketing_category": "ANDA",
"nonproprietary_name": "Varenicline tartrate",
"start_marketing_date": "20231023",
"active_numerator_strength": null
}Access this data programmatically
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