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United States · US · US:60505-3615_4fb749d9-409f-d07a-7006-394063557043
VARENICLINE
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerApotex Corp
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1160505361541 KIT in 1 CARTON (60505-3615-4) * 11 TABLET, FILM COATED in 1 BLISTER PACK (60505-3606-1) * 42 TABLET, FILM COATED in 1 BLISTER PACK (60505-3607-1)
Annotations
Orange Book
A201962
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": "ORAL",
"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": "60505-3615_4fb749d9-409f-d07a-7006-394063557043",
"productndc": "60505-3615",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "201962",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 0.5MG BASE",
"product_no": "001",
"approval_date": "Jan 25, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 1MG BASE",
"product_no": "002",
"approval_date": "Jan 25, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "VARENICLINE",
"active_ingred_unit": null,
"application_number": "ANDA201962",
"marketing_category": "ANDA",
"nonproprietary_name": "VARENICLINE",
"start_marketing_date": "20240115",
"active_numerator_strength": null
}Access this data programmatically
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