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United States · US · US:63187-618_1da9a839-db61-41e9-a214-d007b8f59820
CHANTIX
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163187618531 KIT in 1 CARTON (63187-618-53) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
Orange Book
N021928
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"f0ff4f27-5185-4881-a749-c6b7a0ca5696": {
"match": "brand_token",
"title": "CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]",
"spl_version": "49",
"published_date": "2026-01-23"
}
},
"productid": "63187-618_1da9a839-db61-41e9-a214-d007b8f59820",
"productndc": "63187-618",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "021928",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "001",
"approval_date": "May 10, 2006"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "002",
"approval_date": "May 10, 2006"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "CHANTIX",
"active_ingred_unit": null,
"application_number": "NDA021928",
"marketing_category": "NDA",
"nonproprietary_name": "varenicline tartrate",
"start_marketing_date": "20060510",
"active_numerator_strength": null
}Access this data programmatically
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