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VARENICLINE

Prescription ANDA TE AB
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
VARENICLINE
Generic name
Varenicline
Dosage form
Tablet
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Umedica Laboratories USA Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
5
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Varenicline Tartrate .5 mg/1 636671 View
Varenicline Tartrate 1 mg/1 636671 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet
Route of administration
Oral
Presentations
7

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Cholinergic Agonists [MoA] MoA 8 members — no class page
Cholinergic Receptor Agonist [EPC] EPC All 10 members
Partial Cholinergic Nicotinic Agonist [EPC] EPC 4 members — no class page
Partial Cholinergic Nicotinic Agonists [MoA] MoA 4 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
218985
Application type
ANDA · Abbreviated New Drug Application
Approval date
January 9, 2026
Sponsor
UMEDICA
Products on application
2
Submissions recorded
1
Products approved under application 218985.
Product Trade name Form Strength Ingredient Status TE Flags
218985-001 VARENICLINE TARTRATE TABLET VARENICLINE TARTRATE Prescription AB
218985-002 VARENICLINE TARTRATE TABLET VARENICLINE TARTRATE Prescription AB

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
No
Reference Standard
No

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 218985.
Type No. Action Status Date Review
Original application 1 Approved January 9, 2026 Standard

Adverse event reports

Source: openFDA FAERS
79,554
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: VARENICLINE TARTRATE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
60290-077-01 60290-077 Umedica Laboratories USA Inc. 56 TABLET in 1 BOTTLE (60290-077-01) January 9, 2026
60290-077-02 60290-077 Umedica Laboratories USA Inc. 60 BLISTER PACK in 1 CARTON (60290-077-02) / 1 TABLET in 1 BLISTER PACK January 9, 2026
60290-078-01 60290-078 Umedica Laboratories USA Inc. 56 TABLET in 1 BOTTLE (60290-078-01) January 9, 2026
60290-078-02 60290-078 Umedica Laboratories USA Inc. 60 BLISTER PACK in 1 CARTON (60290-078-02) / 1 TABLET in 1 BLISTER PACK January 9, 2026
60290-078-03 60290-078 Umedica Laboratories USA Inc. 56 TABLET in 1 BLISTER PACK (60290-078-03) April 17, 2026
60290-077 60290-077 Umedica Laboratories USA Inc. — January 9, 2026
60290-078 60290-078 Umedica Laboratories USA Inc. — January 9, 2026

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.