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 KIT
Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-577
Product ID 33342-577_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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342577
Hyphenated Format 33342-577

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: label

Resolved Composition

Strengths
  • 0.5 mg
  • 1 mg
source: label
Packaging
  • 1 KIT in 1 CARTON (33342-577-49) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

33342-577-49 1 KIT in 1 CARTON (33342-577-49) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Varenicline ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"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": "1 KIT in 1 CARTON (33342-577-49)  *  11 TABLET, FILM COATED in 1 BLISTER PACK *  42 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "33342-577-49", "marketing_start_date": "20241210"}], "brand_name": "Varenicline", "product_id": "33342-577_c6a5644a-f80a-4e20-9850-aea0360a76fd", "dosage_form": "KIT", "product_ndc": "33342-577", "generic_name": "Varenicline", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Varenicline", "application_number": "ANDA215048", "marketing_category": "ANDA", "marketing_start_date": "20241210", "listing_expiration_date": "20261231"}