varenicline

Generic: varenicline tartrate

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name varenicline
Generic Name varenicline tartrate
Labeler ascend laboratories, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

varenicline tartrate 1 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-744
Product ID 67877-744_be62466c-d597-473e-8796-76d3f5bf6885
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214557
Listing Expiration 2026-12-31
Marketing Start 2023-08-25

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 67877744
Hyphenated Format 67877-744

Supplemental Identifiers

RxCUI
636671 636676 749289 749788
UPC
0367877745541
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 ANDA214557 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (67877-744-54) / 56 TABLET, FILM COATED in 1 BLISTER PACK
  • 56 TABLET, FILM COATED in 1 BOTTLE (67877-744-95)
source: ndc

Packages (2)

67877-744-54 1 BLISTER PACK in 1 CARTON (67877-744-54) / 56 TABLET, FILM COATED in 1 BLISTER PACK 67877-744-95 56 TABLET, FILM COATED in 1 BOTTLE (67877-744-95)

Ingredients (1)

varenicline tartrate (1 mg/1)

Linked Drug Pages (1)

varenicline, Varenicline ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "be62466c-d597-473e-8796-76d3f5bf6885", "openfda": {"upc": ["0367877745541"], "unii": ["82269ASB48"], "rxcui": ["636671", "636676", "749289", "749788"], "spl_set_id": ["e22e2a6a-66b4-459c-b978-51700e31a1a9"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (67877-744-54)  / 56 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "67877-744-54", "marketing_start_date": "20230825"}, {"sample": false, "description": "56 TABLET, FILM COATED in 1 BOTTLE (67877-744-95)", "package_ndc": "67877-744-95", "marketing_start_date": "20230825"}], "brand_name": "varenicline", "product_id": "67877-744_be62466c-d597-473e-8796-76d3f5bf6885", "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": "67877-744", "generic_name": "varenicline tartrate", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "varenicline", "active_ingredients": [{"name": "VARENICLINE TARTRATE", "strength": "1 mg/1"}], "application_number": "ANDA214557", "marketing_category": "ANDA", "marketing_start_date": "20230825", "listing_expiration_date": "20261231"}