varenicline

Generic: varenicline

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name varenicline
Generic Name varenicline
Labeler mylan pharmaceuticals inc.
Dosage Form KIT
Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-5091
Product ID 0378-5091_5b7b6e3b-f427-4000-b252-968f3adbaa3b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202019
Marketing Start 2024-03-14
Marketing End 2026-04-30

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03785091
Hyphenated Format 0378-5091

Supplemental Identifiers

RxCUI
636671 636676 749289
UPC
0303785090731 0303785089735
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 ANDA202019 (source: ndc)
Routes
oral
source: label

Resolved Composition

Strengths
  • 0.855 mg
  • 1.710 mg
  • 0.5 mg
  • 1 mg
source: label
Packaging
  • 1 KIT in 1 KIT (0378-5091-85) * 11 TABLET, FILM COATED in 1 BLISTER PACK (0378-5089-46) * 42 TABLET, FILM COATED in 1 BLISTER PACK (0378-5090-23)
source: ndc

Packages (1)

0378-5091-85 1 KIT in 1 KIT (0378-5091-85) * 11 TABLET, FILM COATED in 1 BLISTER PACK (0378-5089-46) * 42 TABLET, FILM COATED in 1 BLISTER PACK (0378-5090-23)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Varenicline ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "5b7b6e3b-f427-4000-b252-968f3adbaa3b", "openfda": {"upc": ["0303785090731", "0303785089735"], "unii": ["82269ASB48"], "rxcui": ["636671", "636676", "749289"], "spl_set_id": ["4233fb78-ac6c-49f3-aad8-7e4bee18cac6"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 KIT (0378-5091-85)  *  11 TABLET, FILM COATED in 1 BLISTER PACK (0378-5089-46)  *  42 TABLET, FILM COATED in 1 BLISTER PACK (0378-5090-23)", "package_ndc": "0378-5091-85", "marketing_end_date": "20260430", "marketing_start_date": "20240314"}], "brand_name": "Varenicline", "product_id": "0378-5091_5b7b6e3b-f427-4000-b252-968f3adbaa3b", "dosage_form": "KIT", "product_ndc": "0378-5091", "generic_name": "Varenicline", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Varenicline", "application_number": "ANDA202019", "marketing_category": "ANDA", "marketing_end_date": "20260430", "marketing_start_date": "20240314"}