varenicline

Generic: varenicline

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

Drug Facts

Product Profile

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

varenicline tartrate .5 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70748-127
Product ID 70748-127_3647a217-0da1-4778-adea-08d19a9c446f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211862
Listing Expiration 2026-12-31
Marketing Start 2024-01-09

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 70748127
Hyphenated Format 70748-127

Supplemental Identifiers

RxCUI
636671 636676 749289
UPC
0370748128497 0370748127490
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 (source: ndc)
Application Number ANDA211862 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 56 TABLET, FILM COATED in 1 BOTTLE (70748-127-49)
source: ndc

Packages (1)

70748-127-49 56 TABLET, FILM COATED in 1 BOTTLE (70748-127-49)

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": "3647a217-0da1-4778-adea-08d19a9c446f", "openfda": {"upc": ["0370748128497", "0370748127490"], "unii": ["82269ASB48"], "rxcui": ["636671", "636676", "749289"], "spl_set_id": ["bf20c4cc-1731-4873-8de1-b93d17591e9f"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "56 TABLET, FILM COATED in 1 BOTTLE (70748-127-49)", "package_ndc": "70748-127-49", "marketing_start_date": "20240109"}], "brand_name": "VARENICLINE", "product_id": "70748-127_3647a217-0da1-4778-adea-08d19a9c446f", "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": "70748-127", "generic_name": "VARENICLINE", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VARENICLINE", "active_ingredients": [{"name": "VARENICLINE TARTRATE", "strength": ".5 mg/1"}], "application_number": "ANDA211862", "marketing_category": "ANDA", "marketing_start_date": "20240109", "listing_expiration_date": "20261231"}