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United States · US · US:43598-023_65233c50-9a25-15c3-cc2b-98713a8173b2
varenicline tartrate
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr. Reddys Laboratories Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1143598023531 KIT in 1 CARTON (43598-023-53) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
Orange Book
A215931
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": "43598-023_65233c50-9a25-15c3-cc2b-98713a8173b2",
"productndc": "43598-023",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "215931",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 0.5MG BASE",
"product_no": "001",
"approval_date": "Oct 1, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 1MG BASE",
"product_no": "002",
"approval_date": "Oct 1, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "varenicline tartrate",
"active_ingred_unit": null,
"application_number": "ANDA215931",
"marketing_category": "ANDA",
"nonproprietary_name": "varenicline tartrate",
"start_marketing_date": "20241213",
"active_numerator_strength": null
}Access this data programmatically
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