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Ontario coverage, price, criteria word for word, Health Canada status and shortages for one product

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TESTOSTERONE

All products: Limited Use (codes 397)

Other products in the same Health Canada class (G03BA) — coverage varies; not interchangeable

  • Testosterone cypionate (Depo-Testosterone): limited Use 397, Not a benefit
  • Testosterone enanthate (Delatestryl): limited Use 397, Not a benefit
  • Testosterone undecanoate (Andriol): limited Use 397, Not a benefit

Androgel · DIN 02245346 · 1% · 5.0g Foil Packet

Limited Use — Reason for Use code 397 requiredMarketed · checked 2026-09-19
StatusLimited Use — Reason for Use code 397 required
Write on scriptLU code 397 (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 397
Reason for Use code 397 For male patients with confirmed low morning serum testosterone levels associated with documented, symptomatic hypothalamic, pituitary or testicular disease, or in HIV-infected patients. Note: Older males with nonspecific symptoms of fatigue, malaise, depression who have a low normal random testosterone level do not satisfy these criteria. Coverage limit: LU Authorization Period: 1 year
Savings card: RxHelp ONE lists Androgel (read 2026-09-10) — brand-name savings card, free; cannot be combined with another card on the same claim. (rxhelp.ca ↗)
1 brand, same coverage
Androgel · DIN 02245346 Manufacturer: Solvay Pharma Inc.; listing date 2005-02-22 Health Canada: Marketed since 2016-04-07 · brand ANDROGEL · ATC G03BA03 TESTOSTERONE · form Gel · route Transdermal · ingredients TESTOSTERONE 1 % · company Bgp pharma ulc · schedule Controlled drugs (cdsa iv)
Check this DIN again · Health Canada product record

Ministry pays: $2.9575 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=69385 · Verify on the e-Formulary ↗ (DIN 02245346)

Source record
DIN 02245346: Androgel Raw flags: sec12=Y, sec3=Y Item: 680800031; group id 723; item number 1785; lccId 00160; manufacturer id SPH Source form: 5.0g Foil Packet; strength: 1% Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $4.5117; ministry $2.9575 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02245346 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=69385
Interchangeable products
Taro-Testosterone Gel · DIN 02463806 · $2.9575
Shortage status: not checked (no credentials)
Other drugs in the same formulary class (68:08 Androgens) and how they are covered

Matched class: 68:08 Androgens

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: DANAZOL 68:08 Androgens

TESTOSTERONE CYPIONATE

· 2 products · Listed, not a benefit (1), Limited Use, codes 397 (1) · strengths: 100mg/mL · Oily Inj Sol-10mL Pk

TESTOSTERONE ENANTHATE

· 2 products · Listed, not a benefit (1), Limited Use, codes 397 (1) · strengths: 1000mg/5mL · Oily Inj Sol-5mL Pk

TESTOSTERONE UNDECANOATE

· 2 products · Listed, not a benefit (1), Limited Use, codes 397 (1) · strengths: 40mg · Cap

DANAZOL

· 2 products · General benefit · strengths: 100mg, 200mg · Cap Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 68:08
Full class listing Related classes: 68:04 Corticosteroids, 68:12 Contraceptives, 68:16 Estrogens, 68:20 Anti-Diabetic Agents, 68:24 Parathyroid Agents, 68:28 Pituitary Agents, 68:32 Progestogens and Oral Contraceptives, 68:36 Thyroids, 68:38 Anti-Thyroids Same formulary class, not same indication: class membership alone does not establish equivalent uses.
What the Health Canada label says it is for
1 INDICATIONS ANDROGEL (testosterone) is indicated for: • testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism). ANDROGEL should not be used to treat non-specific symptoms suggestive of hypogonadism if testosterone deficiency has not been demonstrated and if other etiologies responsible for the symptoms have not been excluded. Testosterone deficiency should be clearly demonstrated by clinical features and confirmed by biochemical assays (Endocrine Society Guidelines recommend two separate tests preferably in the morning) before initiating therapy with any testosterone replacement, including ANDROGEL treatment. Due to variability in laboratory values, all measures of testosterone should be carried out in the same laboratory. 1.1 Pediatrics ANDROGEL is not indicated for use in children < 18 years of age since safety and efficacy have not been established in this patient population (see 7.1.3 Pediatrics). 1.2 Geriatrics There are limited controlled clinical study data supporting the use of ANDROGEL in the geriatric population (see 7 WARNINGS AND PRECAUTIONS… https://pdf.hres.ca/dpd_pm/00081277.PDF PM date: FEB 06, 2002 Source product: ANDROGEL; DIN 02245345; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.