varenicline

Generic: varenicline

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

varenicline tartrate 1 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-490
Product ID 33342-490_c6a5644a-f80a-4e20-9850-aea0360a76fd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215048
Listing Expiration 2026-12-31
Marketing Start 2024-12-10

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 33342490
Hyphenated Format 33342-490

Supplemental Identifiers

RxCUI
636671 636676 749289
UPC
0333342489197 0333342490193
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 ANDA215048 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 56 TABLET, FILM COATED in 1 BOTTLE (33342-490-19)
  • 1 BLISTER PACK in 1 CARTON (33342-490-27) / 56 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (2)

33342-490-19 56 TABLET, FILM COATED in 1 BOTTLE (33342-490-19) 33342-490-27 1 BLISTER PACK in 1 CARTON (33342-490-27) / 56 TABLET, FILM COATED in 1 BLISTER PACK

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": "c6a5644a-f80a-4e20-9850-aea0360a76fd", "openfda": {"upc": ["0333342489197", "0333342490193"], "unii": ["82269ASB48"], "rxcui": ["636671", "636676", "749289"], "spl_set_id": ["c325d582-8f43-40ea-b348-87837de97a07"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "56 TABLET, FILM COATED in 1 BOTTLE (33342-490-19)", "package_ndc": "33342-490-19", "marketing_start_date": "20241210"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (33342-490-27)  / 56 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "33342-490-27", "marketing_start_date": "20241210"}], "brand_name": "Varenicline", "product_id": "33342-490_c6a5644a-f80a-4e20-9850-aea0360a76fd", "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": "33342-490", "generic_name": "Varenicline", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Varenicline", "active_ingredients": [{"name": "VARENICLINE TARTRATE", "strength": "1 mg/1"}], "application_number": "ANDA215048", "marketing_category": "ANDA", "marketing_start_date": "20241210", "listing_expiration_date": "20261231"}