varenicline tartrate

Generic: varenicline tartrate

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

varenicline tartrate 1 mg/1

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-460
Product ID 42571-460_426f1bdc-211b-b246-e063-6394a90a8de3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218302
Listing Expiration 2026-12-31
Marketing Start 2025-12-01

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 42571460
Hyphenated Format 42571-460

Supplemental Identifiers

RxCUI
636671 636676 749289 749788
UPC
0342571475840 0342571460884 0342571460822 0342571459826
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 ANDA218302 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 56 TABLET, FILM COATED in 1 BOTTLE (42571-460-82)
  • 1 BLISTER PACK in 1 CARTON (42571-460-88) / 56 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (2)

42571-460-82 56 TABLET, FILM COATED in 1 BOTTLE (42571-460-82) 42571-460-88 1 BLISTER PACK in 1 CARTON (42571-460-88) / 56 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

varenicline tartrate (1 mg/1)

Linked Drug Pages (1)

varenicline tartrate, Varenicline tartrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "426f1bdc-211b-b246-e063-6394a90a8de3", "openfda": {"upc": ["0342571475840", "0342571460884", "0342571460822", "0342571459826"], "unii": ["82269ASB48"], "rxcui": ["636671", "636676", "749289", "749788"], "spl_set_id": ["ee603a5d-9a3c-4dbd-ba89-faf253dc8c42"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "56 TABLET, FILM COATED in 1 BOTTLE (42571-460-82)", "package_ndc": "42571-460-82", "marketing_start_date": "20251201"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (42571-460-88)  / 56 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "42571-460-88", "marketing_start_date": "20251201"}], "brand_name": "varenicline tartrate", "product_id": "42571-460_426f1bdc-211b-b246-e063-6394a90a8de3", "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": "42571-460", "generic_name": "varenicline tartrate", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "varenicline tartrate", "active_ingredients": [{"name": "VARENICLINE TARTRATE", "strength": "1 mg/1"}], "application_number": "ANDA218302", "marketing_category": "ANDA", "marketing_start_date": "20251201", "listing_expiration_date": "20261231"}