United States · FDA National Drug Code directory
VARENICLINE TARTRATE
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
- 69315-403_cd15d74e-92d3-4bf0-8c76-a01f9190b172
- Product NDC
- 69315-403
- Form
- TABLET, FILM COATED
- Composition / generic term
- VARENICLINE TARTRATE
- Labeler
- Leading Pharma, LLC
- Marketing category
- ANDA
- Marketing start / end (source format)
- 20231001
- Source listing expiry
- 20261231
Source-listed ingredients
- VARENICLINE TARTRATE — 1 mg/561
These values do not establish equivalence or a dose recommendation.
Packages
- 56 TABLET, FILM COATED in 1 BOTTLE (69315-403-56) · 69315-403-56
- 1 BLISTER PACK in 1 BOX (69315-403-58) / 56 TABLET, FILM COATED in 1 BLISTER PACK · 69315-403-58
Source and coverage
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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.
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