varenicline

Generic: varenicline tartrate

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name varenicline
Generic Name varenicline tartrate
Labeler american health packaging
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

varenicline tartrate 1 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-648
Product ID 60687-648_4599c6fb-66cd-c7fe-e063-6294a90ac97f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201785
Marketing Start 2022-02-11
Marketing End 2026-10-31

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 60687648
Hyphenated Format 60687-648

Supplemental Identifiers

RxCUI
636676
UNII
82269ASB48

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 ANDA201785 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (60687-648-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-648-11)
source: ndc

Packages (1)

60687-648-21 30 BLISTER PACK in 1 CARTON (60687-648-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-648-11)

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": "4599c6fb-66cd-c7fe-e063-6294a90ac97f", "openfda": {"unii": ["82269ASB48"], "rxcui": ["636676"], "spl_set_id": ["16a03b5e-03e0-4b0b-92a4-aaf0669906f7"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (60687-648-21)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-648-11)", "package_ndc": "60687-648-21", "marketing_end_date": "20261031", "marketing_start_date": "20220211"}], "brand_name": "Varenicline", "product_id": "60687-648_4599c6fb-66cd-c7fe-e063-6294a90ac97f", "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": "60687-648", "generic_name": "varenicline tartrate", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Varenicline", "active_ingredients": [{"name": "VARENICLINE TARTRATE", "strength": "1 mg/1"}], "application_number": "ANDA201785", "marketing_category": "ANDA", "marketing_end_date": "20261031", "marketing_start_date": "20220211"}