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VARENICLINE TARTRATE

All products: Limited Use (codes 423)

NRA-Varenicline · DIN 02542986 · 0.5mg & 1.0mg · tablet (Starter Pack-53 Tabs)

Limited Use — Reason for Use code 423 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 423 required
Write on scriptLU code 423 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 423
Reason for Use code 423 For smoking-cessation treatment in adults, in conjunction with smoking-cessation counseling. Network Note: Limited to 12 weeks (168 tablets) of reimbursement per 365 days per patient. Coverage limit: LU Authorization Period: 12 Weeks.
1 brand, same coverage
NRA-Varenicline · DIN 02542986 Manufacturer: Nora Pharma; listing date 2024-08-30 Health Canada: Marketed since 2024-06-19 · brand NRA-VARENICLINE · ATC N07BA03 VARENICLINE · form Tablet, Kit · route Oral · ingredients VARENICLINE (VARENICLINE TARTRATE) 1 MG, VARENICLINE (VARENICLINE TARTRATE) 0.5 MG · company Nora pharma inc · schedule Prescription
Check this DIN again · Health Canada product record

NRA-Varenicline: Formulary list price $24.3853/unit (unit not stated in source; not the patient's cost)

Ministry pays: $24.3853 per source unit.

Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.

Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=103149 · Verify on the e-Formulary ↗ (DIN 02542986)

Source record
DIN 02542986: NRA-Varenicline Raw flags: sec12=Y, sec3=Y Item: 920000702; group id 989; item number 2324; lccId 00211; manufacturer id NRA Source form: Tab (Starter Pack-53 Tabs); strength: 0.5mg & 1.0mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $24.3853; ministry $24.3853 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02542986 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=103149
Interchangeable products
Apo-Varenicline · DIN 02435675 · $24.3853 Champix · DIN 09857519 · not recorded Mint-Varenicline · DIN 02546965 · $24.3853 Teva-Varenicline · DIN 09857631 · $24.3853
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02542986
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Other drugs in the same formulary class (92:00 UNCLASSIFIED THERAPEUTIC AGENTS) and how they are covered

Matched class: 92:00 UNCLASSIFIED THERAPEUTIC AGENTS

Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment. Covered without a code on the Ontario formulary: ALENDRONATE & CHOLECALCIFEROL, AZATHIOPRINE, CYCLOSPORINE, GLUCAGON RDNA ORIGIN, LANREOTIDE ACETATE, LEFLUNOMIDE, LEVODOPA & BENSERAZIDE, MYCOPHENOLATE SODIUM Some products covered without a code (check the product listing): ALENDRONATE, ALLOPURINOL, AMANTADINE HCL, BROMOCRIPTINE, CLOPIDOGREL BISULFATE, LEVODOPA & CARBIDOPA, MYCOPHENOLATE MOFETIL, OCTREOTIDE, RISEDRONATE SODIUM, ROPINIROLE, SELEGILINE HCL, TAMSULOSIN HCL 92:00 UNCLASSIFIED THERAPEUTIC AGENTS

ALENDRONATE

· 28 products · Off-Formulary Interchangeable, not an ODB benefit (4), Listed, not a benefit (1), General benefit (23) · strengths: 5mg, 10mg, 70mg · Tab

ALENDRONATE & CHOLECALCIFEROL

· 6 products · General benefit · strengths: 70mg & 70mcg, 70mg & 140mcg · Tab

ALLOPURINOL

· 10 products · General benefit (6), Listed, not a benefit (4) · strengths: 100mg, 200mg, 300mg · Tab

AMANTADINE HCL

· 5 products · Listed, not a benefit (2), General benefit (3) · strengths: 100mg, 10mg/mL · Cap, O/L

AZATHIOPRINE

· 3 products · General benefit · strengths: 50mg · Tab

BROMOCRIPTINE

· 4 products · Listed, not a benefit (2), General benefit (2) · strengths: 5mg, 2.5mg · Cap, Tab

CLOPIDOGREL BISULFATE

· 19 products · General benefit (16), Off-Formulary Interchangeable, not an ODB benefit (3) · strengths: 75mg, 300mg · Tab

CYCLOSPORINE

· 8 products · General benefit · strengths: 10mg, 25mg, 50mg, 100mg, 100mg/mL · Cap, O/L

GLUCAGON RDNA ORIGIN

· 2 products · General benefit · strengths: 1mg/Vial · Inj Pd-Syr Pk, Inj Pd-Vial Pk

LANREOTIDE ACETATE

· 6 products · General benefit · strengths: 60mg/Syr, 90mg/Syr, 120mg/Syr · ER Pref Syr Pk

LEFLUNOMIDE

· 16 products · General benefit · strengths: 10mg, 20mg · Tab

LEVODOPA & BENSERAZIDE

· 3 products · General benefit · strengths: 50mg & 12.5mg, 100mg & 25mg, 200mg & 50mg · Cap Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 92:00 and 75 more
Full class listing Related classes: Same formulary class, not same indication: class membership alone does not establish equivalent uses.
What the Health Canada label says it is for
INDICATIONS AND CLINICAL USE Adults APO-VARENICLINE (varenicline tartrate) is indicated for smoking-cessation treatment in adults, in conjunction with smoking-cessation counselling. Geriatrics (> 65 years of age): No dosage adjustment is necessary for healthy elderly patients. However, varenicline is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see WARNINGS AND PRECAUTIONS, Special Populations: Geriatrics). Pediatrics (< 18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of varenicline in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use (see WARNINGS AND PRECAUTIONS, Special Populations: Pediatrics). https://pdf.hres.ca/dpd_pm/00073865.PDF PM date: December 18, 2023 Source product: APO-VARENICLINE; DIN 02419882; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.
Free programs for Smoking cessation (Ontario): Ontario Drug Benefit (ODB) Plan coverage of Champix® and Zyban® — coverage of varenicline (Champix®) and bupropion (Zyban®); generic varenicline and bupropion are Limited Use (Reason for Use code 423 for varenicline: 'For smoking-cessation treatment in adults, in conjunction with smoking-cessation counseling', limited to 12 weeks, 168 tablets, per 365 days; code 315 for bupropion) — patients who are seniors (age 65+), in long term-care homes, or those on social assistance (welfare or because of disability) — not stated (toronto.ca, Sep 9, 2026 ↗) Implementing STOP (Smoking Treatment for Ontario Patients) — publicly funded Nicotine Replacement Therapy (NRT) for your patients — residents of Ontario — free (intrepidlab.ca, Sep 9, 2026 ↗) STOP on the Net — free nicotine replacement therapy (NRT) patches and gum/lozenges for 6 weeks of treatment mailed to you within 2 weeks of enrollment — 18 years of age or older and lives within Ontario — free (intrepidlab.ca, Sep 9, 2026 ↗) Smokers' Helpline — quit coach for free, confidential, one-to-one support — patients who want tobacco use cessation counseling/support — free (toronto.ca, Sep 9, 2026 ↗) Pharmacy Smoking Cessation Program — smoking cessation counseling from a pharmacist — eligible ODB recipients — not stated (toronto.ca, Sep 9, 2026 ↗) The Guidebook also includes information on the Pharmacy Smoking Cessation Program for Ontario Drug Benefit recipients who want to quit smoking as part of the Ontario Government’s support to quit smoking. (ontario.ca, Updated August 24, 2023 ↗)