varenicline

Generic: varenicline

Labeler: apotex corp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name varenicline
Generic Name varenicline
Labeler apotex corp
Dosage Form KIT
Routes
ORAL
Manufacturer
Apotex Corp

Identifiers & Regulatory

Product NDC 60505-3615
Product ID 60505-3615_4fb749d9-409f-d07a-7006-394063557043
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201962
Listing Expiration 2026-12-31
Marketing Start 2024-01-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605053615
Hyphenated Format 60505-3615

Supplemental Identifiers

RxCUI
636671 636676 749289 749788
UPC
0360505361458 0360505361328
UNII
82269ASB48

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name varenicline (source: ndc)
Generic Name varenicline (source: ndc)
Application Number ANDA201962 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 0.5 mg
  • 1 mg
source: label
Packaging
  • 1 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)
source: ndc

Packages (1)

60505-3615-4 1 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)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

VARENICLINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4fb749d9-409f-d07a-7006-394063557043", "openfda": {"upc": ["0360505361458", "0360505361328"], "unii": ["82269ASB48"], "rxcui": ["636671", "636676", "749289", "749788"], "spl_set_id": ["78d1857f-8708-5410-792f-4a3e5e7971a5"], "manufacturer_name": ["Apotex Corp"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 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)", "package_ndc": "60505-3615-4", "marketing_start_date": "20240115"}], "brand_name": "VARENICLINE", "product_id": "60505-3615_4fb749d9-409f-d07a-7006-394063557043", "dosage_form": "KIT", "product_ndc": "60505-3615", "generic_name": "VARENICLINE", "labeler_name": "Apotex Corp", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VARENICLINE", "application_number": "ANDA201962", "marketing_category": "ANDA", "marketing_start_date": "20240115", "listing_expiration_date": "20261231"}