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United States · US · US:42571-475_426f1bdc-211b-b246-e063-6394a90a8de3
Varenicline tartrate
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMicro Labs Limited
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1142571475841 KIT in 1 CARTON (42571-475-84) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
Orange Book
A218302
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": "42571-475_426f1bdc-211b-b246-e063-6394a90a8de3",
"productndc": "42571-475",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "218302",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 0.5MG BASE",
"product_no": "001",
"approval_date": "Oct 29, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 1MG BASE",
"product_no": "002",
"approval_date": "Oct 29, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Varenicline tartrate",
"active_ingred_unit": null,
"application_number": "ANDA218302",
"marketing_category": "ANDA",
"nonproprietary_name": "Varenicline tartrate",
"start_marketing_date": "20251201",
"active_numerator_strength": null
}Access this data programmatically
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