varenicline tartrate

Generic: varenicline tartrate

Labeler: indoco remedies limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name varenicline tartrate
Generic Name varenicline tartrate
Labeler indoco remedies limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

varenicline tartrate .5 mg/1

Manufacturer
Indoco Remedies Limited

Identifiers & Regulatory

Product NDC 14445-153
Product ID 14445-153_97b537d2-8829-42ad-86e9-8523b4430843
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219106
Listing Expiration 2026-12-31
Marketing Start 2024-11-01

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 14445153
Hyphenated Format 14445-153

Supplemental Identifiers

RxCUI
636671 636676 749289
UPC
0314445155011
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 tartrate (source: ndc)
Generic Name varenicline tartrate (source: ndc)
Application Number ANDA219106 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 56 TABLET, FILM COATED in 1 BOTTLE (14445-153-56)
source: ndc

Packages (1)

14445-153-56 56 TABLET, FILM COATED in 1 BOTTLE (14445-153-56)

Ingredients (1)

varenicline tartrate (.5 mg/1)

Linked Drug Pages (1)

Varenicline tartrate, Varenicline ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "97b537d2-8829-42ad-86e9-8523b4430843", "openfda": {"upc": ["0314445155011"], "unii": ["82269ASB48"], "rxcui": ["636671", "636676", "749289"], "spl_set_id": ["cd83bc6c-20f4-42e1-adb4-a3d1d89413f4"], "manufacturer_name": ["Indoco Remedies Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "56 TABLET, FILM COATED in 1 BOTTLE (14445-153-56)", "package_ndc": "14445-153-56", "marketing_start_date": "20241101"}], "brand_name": "Varenicline tartrate", "product_id": "14445-153_97b537d2-8829-42ad-86e9-8523b4430843", "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": "14445-153", "generic_name": "Varenicline tartrate", "labeler_name": "Indoco Remedies Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Varenicline tartrate", "active_ingredients": [{"name": "VARENICLINE TARTRATE", "strength": ".5 mg/1"}], "application_number": "ANDA219106", "marketing_category": "ANDA", "marketing_start_date": "20241101", "listing_expiration_date": "20261231"}