varenicline

Generic: varenicline tartrate

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name varenicline
Generic Name varenicline tartrate
Labeler avkare
Dosage Form KIT
Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-929
Product ID 42291-929_48bfad2d-97de-5ed7-e063-6394a90a2e86
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214557
Listing Expiration 2027-12-31
Marketing Start 2023-09-14

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291929
Hyphenated Format 42291-929

Supplemental Identifiers

RxCUI
636671 636676 749289
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 tartrate (source: ndc)
Application Number ANDA214557 (source: ndc)
Routes
oral
source: label

Resolved Composition

Strengths
  • 0.5 mg
  • 1 mg
source: label
Packaging
  • 1 KIT in 1 CARTON (42291-929-53) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

42291-929-53 1 KIT in 1 CARTON (42291-929-53) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

varenicline, Varenicline ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "48bfad2d-97de-5ed7-e063-6394a90a2e86", "openfda": {"unii": ["82269ASB48"], "rxcui": ["636671", "636676", "749289"], "spl_set_id": ["0552d7ff-9fe8-9c9f-e063-6394a90a79fe"], "manufacturer_name": ["AvKARE"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (42291-929-53)  *  11 TABLET, FILM COATED in 1 BLISTER PACK *  42 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "42291-929-53", "marketing_start_date": "20230914"}], "brand_name": "Varenicline", "product_id": "42291-929_48bfad2d-97de-5ed7-e063-6394a90a2e86", "dosage_form": "KIT", "product_ndc": "42291-929", "generic_name": "Varenicline tartrate", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Varenicline", "application_number": "ANDA214557", "marketing_category": "ANDA", "marketing_start_date": "20230914", "listing_expiration_date": "20271231"}