varenicline tartrate

Generic: varenicline tartrate

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

Drug Facts

Product Profile

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

varenicline tartrate 1 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-894
Product ID 68462-894_67a82933-5f10-4a9a-8605-d09cd2f08d52
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214255
Listing Expiration 2027-12-31
Marketing Start 2023-08-22

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 68462894
Hyphenated Format 68462-894

Supplemental Identifiers

RxCUI
636671 636676 749289 749788
UPC
0368462893562 0368462894569
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 ANDA214255 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (68462-894-04) / 56 TABLET, FILM COATED in 1 BLISTER PACK
  • 56 TABLET, FILM COATED in 1 BOTTLE (68462-894-56)
source: ndc

Packages (2)

68462-894-04 1 BLISTER PACK in 1 CARTON (68462-894-04) / 56 TABLET, FILM COATED in 1 BLISTER PACK 68462-894-56 56 TABLET, FILM COATED in 1 BOTTLE (68462-894-56)

Ingredients (1)

varenicline tartrate (1 mg/1)

Linked Drug Pages (1)

varenicline tartrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "67a82933-5f10-4a9a-8605-d09cd2f08d52", "openfda": {"upc": ["0368462893562", "0368462894569"], "unii": ["82269ASB48"], "rxcui": ["636671", "636676", "749289", "749788"], "spl_set_id": ["e8a06e8e-1938-412c-a98a-28f0a29fe3ac"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (68462-894-04)  / 56 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "68462-894-04", "marketing_start_date": "20230822"}, {"sample": false, "description": "56 TABLET, FILM COATED in 1 BOTTLE (68462-894-56)", "package_ndc": "68462-894-56", "marketing_start_date": "20230822"}], "brand_name": "varenicline tartrate", "product_id": "68462-894_67a82933-5f10-4a9a-8605-d09cd2f08d52", "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": "68462-894", "generic_name": "varenicline tartrate", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "varenicline tartrate", "active_ingredients": [{"name": "VARENICLINE TARTRATE", "strength": "1 mg/1"}], "application_number": "ANDA214255", "marketing_category": "ANDA", "marketing_start_date": "20230822", "listing_expiration_date": "20271231"}