varenicline

Generic: varenicline

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name varenicline
Generic Name varenicline
Labeler zydus lifesciences limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

varenicline tartrate .5 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1773
Product ID 70771-1773_df89bfa8-f749-4840-a207-6499b82516f5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216723
Listing Expiration 2026-12-31
Marketing Start 2023-06-13

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 707711773
Hyphenated Format 70771-1773

Supplemental Identifiers

RxCUI
636671 636676
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 ANDA216723 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 56 TABLET, FILM COATED in 1 BOTTLE (70771-1773-6)
source: ndc

Packages (1)

70771-1773-6 56 TABLET, FILM COATED in 1 BOTTLE (70771-1773-6)

Ingredients (1)

varenicline tartrate (.5 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": "df89bfa8-f749-4840-a207-6499b82516f5", "openfda": {"unii": ["82269ASB48"], "rxcui": ["636671", "636676"], "spl_set_id": ["481b94af-ee34-44be-8ca1-b2415525efac"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "56 TABLET, FILM COATED in 1 BOTTLE (70771-1773-6)", "package_ndc": "70771-1773-6", "marketing_start_date": "20230613"}], "brand_name": "Varenicline", "product_id": "70771-1773_df89bfa8-f749-4840-a207-6499b82516f5", "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": "70771-1773", "generic_name": "Varenicline", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Varenicline", "active_ingredients": [{"name": "VARENICLINE TARTRATE", "strength": ".5 mg/1"}], "application_number": "ANDA216723", "marketing_category": "ANDA", "marketing_start_date": "20230613", "listing_expiration_date": "20261231"}