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TESTOSTERONE CYPIONATE

All injection strengths: Limited Use (codes 397)

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

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

Taro-Testosterone Cypionate Injection · DIN 02496003 · 100mg/mL · Oily injection solution-10mL Pk

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
1 brand, same coverage
Taro-Testosterone Cypionate Injection · DIN 02496003 Manufacturer: Taro Pharmaceuticals Inc.; listing date 2021-04-30 Health Canada: Marketed since 2020-10-20 · brand TARO-TESTOSTERONE CYPIONATE INJECTION · ATC G03BA03 TESTOSTERONE · form Solution · route Intramuscular · ingredients TESTOSTERONE CYPIONATE 100 MG/ML · company Taro pharmaceuticals inc · schedule Controlled drugs (cdsa iv)
Check this DIN again · Health Canada product record

Taro-Testosterone Cypionate Injection: Formulary list price $34.8780/unit (unit not stated in source; not the patient's cost)

Ministry pays: $34.8780 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=98589 · Verify on the e-Formulary ↗ (DIN 02496003)

Source record
DIN 02496003: Taro-Testosterone Cypionate Injection Raw flags: sec12=Y, sec3=Y Item: 680800013; group id 724; item number 1787; lccId 00175; manufacturer id TAR Source form: Oily Inj Sol-10mL Pk; strength: 100mg/mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $34.8780; ministry $34.8780 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02496003 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=98589
Interchangeable products
Depo-Testosterone · DIN 00030783 · not recorded
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

· 5 products · Limited Use, codes 397 · strengths: 1% · 2.5g Foil Packet, 5.0g Foil Packet, Top Gel-5g 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.
Other drugs whose Health Canada label lists a similar indication: testosterone replacement therapy
From Health Canada product monographs; label wording only, not a treatment recommendation. Matching is lexical and uses one held product label per generic; formulations and qualifying criteria may differ. No displayed matched alternative is a general benefit. TESTOSTERONE ENANTHATE · Listed, not a benefit (1), Limited Use, codes 397 (1) INDICATIONS AND CLINICAL USE Testosterone Enanthate Injection, USP (testosterone enanthate) is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism). PM: https://pdf.hres.ca/dpd_pm/00071616.PDF; date not captured; DIN 02536315; fetched 2026-09-10 Product monograph TESTOSTERONE UNDECANOATE · Listed, not a benefit (1), Limited Use, codes 397 (1) INDICATIONS AND CLINICAL USE Taro-Testosterone (testosterone undecanoate capsules) is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. PM: https://pdf.hres.ca/dpd_pm/00048154.PDF; date not captured; DIN 02421186; fetched 2026-09-10 Product monograph Coverage source: ON formulary extract 2026-08-26
What the Health Canada label says it is for
INDICATIONS AND CLINICAL USE TARO–TESTOSTERONE CYPIONATE INJECTION (testosterone cypionate injection) is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism). TARO–TESTOSTERONE CYPIONATE INJECTION (testosterone cypionate injection) 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 two separate validated biochemical assays (morning testosterone) before initiating therapy with any testosterone replacement, including TARO–TESTOSTERONE CYPIONATE INJECTION treatment. Safety and efficacy of testosterone cypionate injection in men with “age- related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established. Ge riatrics (> 65 ye ars of age ): There are no controlled clinical trial data to support the use of testosterone cypionate injection in the geriatric population (see WARNINGS AND PRECAUTIONS – Spe cia… https://pdf.hres.ca/dpd_pm/00066102.PDF PM date: May 26, 2022 Source product: TARO-TESTOSTERONE CYPIONATE INJECTION; DIN 02496003; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.