United States · FDA National Drug Code directory

Varenicline

A source-listed medicine record.

Factual source checks only. This page is not a clinically reviewed monograph. Historical or discontinued records may be included; listing does not confirm approval, current availability or pharmacy stock.

Medicine identity

Source reference: 33342-577_c6a5644a-f80a-4e20-9850-aea0360a76fd
Product NDC: 33342-577
Form: KIT
Composition / generic term: Varenicline
Labeler: Macleods Pharmaceuticals Limited
Marketing category: ANDA
Marketing start / end (source format): 20241210
Source listing expiry: 20261231

Source-listed ingredients

Separate ingredient quantities are not available in this snapshot. Any composition term above is preserved as source text.

These values do not establish equivalence or a dose recommendation.

Packages

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

Source and coverage

Open FDA National Drug Code directory →

Snapshot retrieved: 2026-09-17. This is the acquisition date, not a medical review date.

Clinical information, images and comparisons appear only when separately reviewed for this record. Coverage may be incomplete. Ask a pharmacist or clinician about your treatment.

Browse United States records →