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
75834-336_077ec752-4145-4592-9ee1-6fdc9a04795a
Product NDC
75834-336
Form
KIT
Composition / generic term
varenicline
Labeler
Nivagen Pharmaceuticals Inc.
Marketing category
ANDA
Marketing start / end (source format)
20260302
Source listing expiry
20271231

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

  • 2 BOX in 1 KIT (75834-336-24) / 1 KIT in 1 BOX * 1 BLISTER PACK in 1 BOX (75834-334-25) / 11 TABLET, FILM COATED in 1 BLISTER PACK * 3 BLISTER PACK in 1 BOX (75834-335-26) / 14 TABLET, FILM COATED in 1 BLISTER PACK · 75834-336-24

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.

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