varenicline

Generic: varenicline tartrate

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

Drug Facts

Product Profile

Brand Name varenicline
Generic Name varenicline tartrate
Labeler marlex pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

varenicline tartrate 1 mg/1

Manufacturer
Marlex Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 10135-809
Product ID 10135-809_3effcc80-3b6f-8853-e063-6394a90a258d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217283
Listing Expiration 2026-12-31
Marketing Start 2025-01-01

Pharmacologic Class

Classes
cholinergic agonists [moa] cholinergic receptor agonist [epc] partial cholinergic nicotinic agonist [epc] partial cholinergic nicotinic agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10135809
Hyphenated Format 10135-809

Supplemental Identifiers

RxCUI
636671 636676
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 ANDA217283 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 56 TABLET, FILM COATED in 1 BOTTLE (10135-809-56)
source: ndc

Packages (1)

10135-809-56 56 TABLET, FILM COATED in 1 BOTTLE (10135-809-56)

Ingredients (1)

varenicline tartrate (1 mg/1)

Linked Drug Pages (1)

Varenicline ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3effcc80-3b6f-8853-e063-6394a90a258d", "openfda": {"unii": ["82269ASB48"], "rxcui": ["636671", "636676"], "spl_set_id": ["29b6b4ca-aeef-1295-e063-6394a90a21b9"], "manufacturer_name": ["Marlex Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "56 TABLET, FILM COATED in 1 BOTTLE (10135-809-56)", "package_ndc": "10135-809-56", "marketing_start_date": "20250101"}], "brand_name": "Varenicline", "product_id": "10135-809_3effcc80-3b6f-8853-e063-6394a90a258d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinergic Agonists [MoA]", "Cholinergic Receptor Agonist [EPC]", "Partial Cholinergic Nicotinic Agonist [EPC]", "Partial Cholinergic Nicotinic Agonists [MoA]"], "product_ndc": "10135-809", "generic_name": "Varenicline tartrate", "labeler_name": "Marlex Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Varenicline", "active_ingredients": [{"name": "VARENICLINE TARTRATE", "strength": "1 mg/1"}], "application_number": "ANDA217283", "marketing_category": "ANDA", "marketing_start_date": "20250101", "listing_expiration_date": "20261231"}