Tlando testosterone undecanoate 112.5 mg Capsule, Liquid Filled, 120-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Androgen class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Testosterone is used to treat low or no testosterone levels in men. Testosterone is a male sex hormone responsible for development and functioning of male sex organs and male characteristics. Testosterone works by replacing testosterone that is normally produced by the body.
Read the full MedlinePlus article ↗- Testosterone replacement is specifically for men whose bodies aren't making enough testosterone because of a medical condition — like a problem with the testes themselves (primary...
- What exactly is testosterone replacement therapy for — do I really need it?
- Yes, this is a serious concern. Children who accidentally touch the gel on your skin or clothing can absorb testosterone and develop early puberty signs — things like pubic hair gr...
- I use the gel — do I really need to worry about my kids or partner being exposed to it?
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Supplement & herbal interactions
Some supplements/herbs that may interact with Testosterone Undecanoate — tap one for details:
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII 5138Q19F1X
Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
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Ascorbyl palmitate is a fat-soluble form of vitamin C used as an antioxidant in medicines. It prevents oils and fats in the product from breaking down and becoming less stable over time.
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A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
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Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII 4763AXI84L
Glyceryl monolinoleate is a fatty substance derived from linoleic acid, a natural oil component. It acts as an emulsifier and surfactant in medicines, helping blend oil and water-based ingredients together for better mixing and stability.
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UNII Q662QK8M3B
Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
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A synthetic oily substance made from castor oil. It works as a solubilizer and emulsifier to help mix oily and water-based ingredients together in the medicine.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
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Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
10 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $7.181 | $861.73 / 120 capsules |
| Medicaid paysCMS SDUD · 12 mo | $7.04 | $844.98 / 120 capsules |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Tlando 112.5 mgthis 74676-0112-02 | Verity | 120 capsules | $7.181 | — | Availability likely | — |
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⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 12310978 ↗ | Method of use | U-4194 | Feb 21, 2039 |
| US 11433083 ↗ | Method of use | U-1500 | Nov 30, 2030 |
| US 11559530 ↗ | Method of use | U-1500 | Nov 28, 2037 |
| US 11364249 ↗ | Method of use | U-1500 | Nov 30, 2030 |
| US 12011503 ↗ | Method of use | U-3964 | Oct 16, 2040 |
| US 12011503 ↗ | Method of use | U-3965 | Oct 16, 2040 |
| US 10716794 ↗ | Method of use | U-1500 | Nov 30, 2030 |
| US 9949985 ↗ | Method of use | U-1500 | Nov 30, 2030 |
| US 11311555 ↗ | Method of use | U-1500 | Nov 30, 2030 |
| US 11464735 ↗ | Method of use | U-1500 | Apr 28, 2041 |
| US 11304960 ↗ | Method of use | U-1500 | Jan 8, 2029 |
| US 10226473 ↗ | Method of use | U-1500 | Nov 30, 2030 |
| US 9943527 ↗ | Method of use | U-1500 | Nov 30, 2030 |
| US 8865695 ↗ | Method of use | U-1500 | Jan 8, 2029 |
| US 8778922 ↗ | Method of use | U-1500 | Jan 8, 2029 |
Is there a generic version of TLANDO 112.5 MG CAPSULE?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 74676-0112-02 You're viewing this | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (74676-0112-2) | 2022-04-15 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE TLANDO is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle stimulating hormone (FSH), luteinizing hormone (LH)) above the normal range [see Dosage and Administration ( 2.2 )].
Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range [see Dosage and Administration ( 2.2 )]. Limitations of Use Safety and efficacy of TLANDO in males less than 18 years old have not been established [see Use in Specific Populations ( 8.4 )] .
Safety and efficacy of TLANDO in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established [see Use in Specific Populations ( 8.5 )] . TLANDO is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone ( 1 ). Limitations of Use Safety and efficacy of TLANDO in males less than 18 years old have not been established ( 1 ).
Safety and efficacy of TLANDO in men with “age-related hypogonadism” have not been established ( 1 ).
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Prior to initiating TLANDO, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range ( 2.2 ). Recommended dosage is 225 mg orally twice daily with food ( 2.3 ). Monitor serum testosterone after initiating TLANDO to determine if TLANDO should be continued or discontinued ( 2.3 ).
2.1Important Dosage Information TLANDO is not substitutable with other oral testosterone undecanoate products.
2.2Confirmation of Hypogonadism Before Initiation of TLANDO Prior to initiating TLANDO, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range.
2.3Recommended Dosage The recommended dosage of TLANDO is 225 mg (taken as two 112.5 mg capsules), orally twice daily, once in the morning and once in the evening. Take with food. Monitoring for Continued Use or Discontinuation Monitor serum testosterone (8 to 9 hours after the morning dose) 3 to 4 weeks after initiating TLANDO, and periodically thereafter.
Based on serum testosterone measurements, determine if TLANDO should be continued or discontinued: Serum testosterone 300 - 1080 ng/dL: continue TLANDO Serum testosterone < 300 ng/dL: discontinue TLANDO Serum testosterone > 1080 ng/dL: discontinue TLANDO
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Capsules: 112.5 mg, white opaque body imprinted with “112” in black ink and grey opaque cap, banded with a colorless gelatin band. Capsules: 112.5 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS TLANDO is contraindicated in: Patients with carcinoma of the breast or known or suspected carcinoma of the prostate [see Warnings and Precautions ( 5.3 )] . Women who are pregnant. Testosterone can cause virilization of the female fetus when administered to a pregnant woman [see Use in Specific Populations ( 8.1 )] .
Known hypersensitivity to testosterone undecanoate or any of TLANDO’s ingredients [see Description ( 11 )]. Carcinoma of the breast or known or suspected carcinoma of the prostate ( 4 ) Women who are pregnant. Testosterone may cause fetal harm ( 4 , 5.6 , 8.1 ) Hypersensitivity to TLANDO or any of its ingredients ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Polycythemia : Monitor hematocrit approximately every 3 months during the first year after beginning TLANDO and then every 6 months thereafter during treatment. Discontinue TLANDO if necessary ( 5.1 ). Venous thromboembolism (VTE) : VTE, including deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients using testosterone products.
Discontinue TLANDO if VTE is suspected and initiate appropriate workup and management ( 5.2 ). Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer : Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH. Evaluate patients for prostate cancer, including monitoring prostate specific antigen (PSA) prior to initiating and during treatment with androgens ( 5.3 ) Blood Pressure Increases: TLANDO can increase blood pressure, which can increase cardiovascular risk over time.
Measure blood pressure periodically. Not recommended for use in men with uncontrolled hypertension ( 5.4 ) Abuse of Testosterone and Monitoring of Serum Testosterone : If testosterone use at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids is suspected, check serum testosterone concentration ( 5.5 ). Potential for Adverse Effects on Spermatogenesis : TLANDO may cause azoospermia ( 5.7 , 8.3 ).
Edema : Edema, with or without congestive heart failure (CHF) may occur in patients with preexisting cardiac, renal, or hepatic disease. Discontinue TLANDO and initiate appropriate workup ( 5.9 ). Sleep Apnea: TLANDO may potentiate sleep apnea in those with risk factors ( 5.10 ).
Lipid Changes : Testosterone may affect serum lipid profile. Monitor patient lipid concentrations; if necessary, adjust dosage of lipid lowering drug(s) or discontinue TLANDO ( 5.12 ). Increases in Prolactin : Monitor serum prolactin levels prior to initiation of TLANDO and 3 to 4 months after starting TLANDO.
Discontinue TLANDO if serum prolactin levels remain elevated ( 5.15 ).
5.1Polycythemia Increases in hematocrit levels, reflective of increases in red blood cell mass, may require discontinuation of TLANDO. Check hematocrit prior to initiating TLANDO. Evaluate hematocrit approximately every 3 months during the first year of treatment, and then every 6 months thereafter while the patient is taking TLANDO.
If hematocrit becomes elevated, stop TLANDO until hematocrit decreases to an acceptable concentration. If TLANDO is restarted and again causes hematocrit to become elevated, stop TLANDO permanently. An increase in red blood cell mass may increase the risk of thromboembolic events [ see Warnings and Precautions ( 5.2 ) ] .
5.2Venous Thromboembolism There have been post marketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone replacement products such as TLANDO. In the Testosterone Replacement therapy for Assessment of long-term Vascular Events and efficacy ResponSE in hypogonadal men (TRAVERSE) Study, a randomized, double-blind, placebo-controlled, cardiovascular (CV) outcomes study, compared to placebo, topical testosterone gel was associated with a numerically higher incidence of VTE (1.7% vs 1.2%) which included DVT (0.6% vs 0.5%) and PE events (0.9% vs 0.5%) [see Adverse Reactions ( 6.1 )].
Evaluate patients who report symptoms of pain, edema, warmth, and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue TLANDO and initiate appropriate workup and management [see Adverse Reactions ( 6.2 )] .
5.3Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer Patients with BPH treated with androgens are at an increased risk for worsening of signs and symptoms of BPH. Monitor patients with BPH for worsening signs and symptoms. Patients treated wi…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥ 2%): increased blood prolactin, hypertension, increased hematocrit, upper respiratory tract infection, weight increased, headache, and musculoskeletal pain ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Verity Pharma at 1-844-837-4891 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . The following clinically significant adverse reactions are discussed elsewhere in the labeling: Polycythemia [see Warnings and Precautions ( 5.1 )] Venous Thromboembolism [see Warnings and Precautions ( 5.2 )] Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer [see Warnings and Precautions ( 5.3 )] Blood Pressure Increases [see Warnings and Precautions ( 5.4 )] Hepatic Adverse Effects [see Warnings and Precautions ( 5.8 )] Edema [see Warnings and Precautions ( 5.9 )] Sleep Apnea [see Warnings and Precautions ( 5.10 )] Gynecomastia [see Warnings and Precautions ( 5.11 )] Lipid Changes [see Warnings and Precautions ( 5.12 )] Hypercalcemia [see Warnings and Precautions ( 5.13 )] Decreased Thyroxine-binding Globulin [see Warnings and Precautions ( 5.14 )] Increases in Prolactin [see Warnings and Precautions ( 5.15 )]
6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of TLANDO 225 mg twice daily, without dose titration, was evaluated in 233 hypogonadal males during two clinical studies: Study LPCN 1021-18-001 (18-001) and Study LPCN 1021-16-002 (16-002) [see Clinical Studies ( 14 )].
In Study 18-001, an uncontrolled ambulatory blood pressure monitoring (ABPM) study, 138 hypogonadal males were treated with TLANDO 225 mg twice daily with morning and evening meals for approximately four months. Patients had a median age of 54 years (range 26-75), 79% were White, 18% were Black, and 2% were Asian. In 138 hypogonadal male patients, 70% (n=96) were obese (BMI≥30 kg/m 2 ), 24% (n=33) reported a history of type 2 diabetes, and 48% (n=66) reported a history of hypertension.
Table 1 summarizes adverse reactions ( > 2%) reported in patients receiving TLANDO in Study 18-001. Table 1. Adverse Reactions ≥ 2% in Patients Receiving TLANDO in Study 18-001 Adverse Reaction Overall (N=138) n (%) Hypertension 7 (5.1) Hematocrit increased 6 (4.3) Upper respiratory tract infection 5 (3.6) Four of the 138 patients (2.9%) in Study 18-001 reported adverse reactions that led to premature discontinuation from the study, including dizziness (n=1), weight increased (n=1), insomnia (n=1), and hypertension (n=2).
In Study 16-002, 95 hypogonadal males were treated with TLANDO 225 mg twice daily with morning and evening meals for approximately 24 days. The dose of TLANDO was not titrated. Patients had a median age of 56 years (range 29-74), 81% were White, 16% were Black, 2% were mixed race, and 1% were Asian; 26% were Hispanic.
In 95 hypogonadal male patients, 70% (n=66) were obese (BMI≥30 kg/m 2 ), 23% (n=22) reported a history of type 2 diabetes, and 50% (n=47) reported a history of hypertension. Table 2 summarized adverse reactions ( > 2%) reported during Study 16-002 in patients receiving TLANDO. Table 2.
Adverse Reactions ≥2% in Patients Receiving TLANDO in Study 16-002 Adverse Reaction Overall (N=95) n (%) Blood prolactin increased 6 (6.3) Weight increased 2 (2.1) Headache 2 (2.1) Musculoskeletal pain 2 (2.1) One of the 95 patients (1.1%) in the 24-day study reported an adverse reaction (gastric ulcer hemorrhage) that led to premature discontinuation from the study. Blood Pressure Increases In Study 18-001 24-hour ambulatory blood pressure monitoring (ABPM) was conducted in 138 male patients, 126 of whom completed the study.
ABPM was conducted at 2 distinct 24-hour time periods: at baseline and following approximately 16…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Insulin: In patients with diabetes, concomitant use with TLANDO may decrease blood glucose and insulin requirements ( 7.1) . Oral Anticoagulants: Concomitant use with TLANDO may cause changes in anticoagulant activity. Monitor International Normalized Ratio and prothrombin time frequently ( 7.2 ).
Corticosteroids: Concomitant use with TLANDO may result in increased fluid retention. Use with caution, particularly in patients with cardiac, renal, or hepatic disease ( 7.3 ). Drugs that May Also Increase Blood Pressure: Concomitant use with TLANDO may lead to additional increases in blood pressure ( 7.4 ).
7.1Insulin Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements.
7.2Oral Anticoagulants Changes in anticoagulant activity may be seen with androgens. Frequent monitoring of INR and prothrombin time may be necessary in patients taking anticoagulants, especially at the initiation and termination of androgen therapy.
7.3Corticosteroids The concurrent use of testosterone with corticosteroids may result in increased fluid retention and should be monitored cautiously, particularly in patients with cardiac, renal or hepatic disease.
7.4Drugs that May Also Increase Blood Pressure Some prescription drugs and nonprescription analgesic and cold medications can increase blood pressure. Concomitant administration of these medications with TLANDO may lead to additional increases in blood pressure [ see Warnings and Precautions ( 5.4 ) ] .
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Geriatric Patients: Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH and hypertension ( 8.5 ).
8.1Pregnancy Risk Summary TLANDO is contraindicated in pregnant women and not indicated for use in females [ see Contraindications ( 4 )] . Testosterone is teratogenic and may cause fetal harm when administered to a pregnant woman based on data from animal studies (see Data ) and its mechanism of action [ see Clinical Pharmacology ( 12.1 ) ] . Exposure of a female fetus to androgens may result in varying degrees of virilization.
In animal developmental studies, exposure to testosterone in utero resulted in hormonal and behavioral changes in offspring and structural impairments of reproductive tissues in female and male offspring. These studies did not meet current standards for nonclinical development toxicity studies. Data Animal Data In developmental studies conducted in rats, rabbits, pigs, sheep and rhesus monkeys, pregnant animals received intramuscular injection of testosterone during the period of organogenesis.
Testosterone treatment at doses that were comparable to those used for testosterone replacement therapy resulted in structural impairments in both female and male offspring. Structural impairments observed in females included increased anogenital distance, phallus development, empty scrotum, no external vagina, intrauterine growth retardation, reduced ovarian reserve, and increased ovarian follicular recruitment. Structural impairments seen in male offspring included increased testicular weight, larger seminal tubular lumen diameter, and higher frequency of occluded tubule lumen.
Increased pituitary weight was seen in both sexes. Testosterone exposure in utero also resulted in hormonal and behavioral changes in offspring. Hypertension was observed in pregnant females and offspring in rats exposed to doses approximately twice those used for testosterone replacement therapy.
8.2Lactation Risk Summary TLANDO is not indicated for use in females.
8.3Females and Males of Reproductive Potential Infertility Males During treatment with large doses of exogenous androgens, including TLANDO, spermatogenesis may be suppressed through feedback inhibition of the hypothalamic-pituitary-testicular axis [ see Warnings and Precautions ( 5.8 ) ] . Reduced fertility is observed in some men taking testosterone replacement therapy. The impact on fertility may be irreversible.
Testicular atrophy, subfertility, and infertility have also been reported in men who abuse anabolic androgenic steroids [ see Drug Abuse and Dependence ( 9.2 ) ] .
8.4Pediatric Use The safety and effectiveness of TLANDO in pediatric patients less than 18 years old have not been established. Improper use may result in acceleration of bone age and premature closure of epiphyses.
8.5Geriatric Use There have not been sufficient numbers of geriatric patients in controlled clinical studies with TLANDO to determine whether efficacy or safety in those over 65 years of age differs from younger subjects. Of the 95 patients enrolled in Study 16-002, the 24-day major safety and effectiveness study utilizing TLANDO, 16 (16.8%) were over 65 years of age. Additionally, there is insufficient long-term safety data in geriatric patients utilizing TLANDO to assess the potentially increased risk of cardiovascular disease and prostate cancer.
Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH and hypertension [see Warnings and Precautions ( 5.3 and 5.4 )].
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary TLANDO is contraindicated in pregnant women and not indicated for use in females [ see Contraindications ( 4 )] . Testosterone is teratogenic and may cause fetal harm when administered to a pregnant woman based on data from animal studies (see Data ) and its mechanism of action [ see Clinical Pharmacology ( 12.1 ) ] . Exposure of a female fetus to androgens may result in varying degrees of virilization.
In animal developmental studies, exposure to testosterone in utero resulted in hormonal and behavioral changes in offspring and structural impairments of reproductive tissues in female and male offspring. These studies did not meet current standards for nonclinical development toxicity studies. Data Animal Data In developmental studies conducted in rats, rabbits, pigs, sheep and rhesus monkeys, pregnant animals received intramuscular injection of testosterone during the period of organogenesis.
Testosterone treatment at doses that were comparable to those used for testosterone replacement therapy resulted in structural impairments in both female and male offspring. Structural impairments observed in females included increased anogenital distance, phallus development, empty scrotum, no external vagina, intrauterine growth retardation, reduced ovarian reserve, and increased ovarian follicular recruitment. Structural impairments seen in male offspring included increased testicular weight, larger seminal tubular lumen diameter, and higher frequency of occluded tubule lumen.
Increased pituitary weight was seen in both sexes. Testosterone exposure in utero also resulted in hormonal and behavioral changes in offspring. Hypertension was observed in pregnant females and offspring in rats exposed to doses approximately twice those used for testosterone replacement therapy.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of TLANDO in pediatric patients less than 18 years old have not been established. Improper use may result in acceleration of bone age and premature closure of epiphyses.
🧓 Geriatric Use ▾
8.5Geriatric Use There have not been sufficient numbers of geriatric patients in controlled clinical studies with TLANDO to determine whether efficacy or safety in those over 65 years of age differs from younger subjects. Of the 95 patients enrolled in Study 16-002, the 24-day major safety and effectiveness study utilizing TLANDO, 16 (16.8%) were over 65 years of age. Additionally, there is insufficient long-term safety data in geriatric patients utilizing TLANDO to assess the potentially increased risk of cardiovascular disease and prostate cancer.
Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH and hypertension [see Warnings and Precautions ( 5.3 and 5.4 )].
🆘 Overdosage ▾
10 OVERDOSAGE There is one report of acute overdosage with use of an approved injectable testosterone product: this subject had serum testosterone levels of up to 11,400 ng/dL with a cerebrovascular accident. Treatment of overdosage consists of discontinuation of TLANDO and appropriate symptomatic and supportive care.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement, vocal cord thickening, alterations in body musculature and fat distribution. Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies.
Primary hypogonadism is caused by defects of the gonads, such as Klinefelter's Syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH).
12.2Pharmacodynamics There is insufficient data to characterize an exposure-response relationship or time course of pharmacodynamic response.
12.3Pharmacokinetics Absorption Testosterone undecanoate is a lipophilic molecule that is primarily absorbed into the lymph system after oral administration and then released into the general blood circulation by the thoracic duct, avoiding absorption into the portal vein thereby circumventing first-pass metabolism in the liver. Testosterone undecanoate is converted to testosterone following absorption. Following administration of 225 mg of TLANDO in ninety-five hypogonadal males, maximum serum testosterone concentrations were observed at a median (Tmax) of about 5 hours.
The mean maximum (Cmax) serum testosterone concentrations observed were 979 ng/dL and 989 ng/dL following the morning and evening TLANDO doses, respectively. The average serum testosterone concentrations over 24 hours (Cavg0-24h) observed following TLANDO administration was 476 ng/dL. Figure 1 shows the mean serum total testosterone concentration-time profile for hypogonadal men (N=90) administered TLANDO.
Figure 1: Mean (±SEM) Serum Total Testosterone Concentrations (ng/dL) Following TLANDO administration, the mean serum dihydrotestosterone (DHT) Cavg0-24h was 108 ng/dL, the mean serum testosterone undecanoate Cavg0-24h was 11,100 ng/dL and the mean serum dihydrotestosterone undecanoate Cavg0-24h was 4,700 ng/dL. Effect of Food Administration of TLANDO with moderate fat containing food did not significantly impact the pharmacokinetic parameters of testosterone compared to high or low fat. However, there is decrease in exposure when administered without food compared to fed conditions.
In studies with 13 to 14 hypogonadal males, mean testosterone Cmax and AUC were comparable when TLANDO was administered with food containing low, moderate or high fat amounts. Administration in fasting conditions resulted in approximately 65 % and 38% lower Cmax and AUC, respectively, compared to administration with food (high fat). Distribution Circulating testosterone is primarily bound in serum to sex hormone-binding globulin (SHBG) and albumin.
Approximately 40% of testosterone in plasma is bound to SHBG, 2% remains unbound (free) and the rest is bound to albumin and other proteins. Elimination The elimination half-life of testosterone undecanoate is approximately 2 hours. Once testosterone is formed from testosterone undecanoate, there is considerable variation in the half-life of testosterone as reported in the literature, ranging from 10 to 100 minutes.
Metabolism Testosterone undecanoate is metabolized to testosterone via ester cleavage of the undecanoate group and reduced to DHTU by 5α-reductase. Testosterone is metabolized to various 17-keto steroids. The major active metabolites of testosterone are DHT and estradiol.
Excretion About 90% of a dose of testosterone given intramuscularly is excreted in the urine as glucuronic and sulfuric acid conjugates of testosterone and its metabolites. About 6% of a dose is excreted in the feces, mostly…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement, vocal cord thickening, alterations in body musculature and fat distribution. Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies.
Primary hypogonadism is caused by defects of the gonads, such as Klinefelter's Syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH).
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING TLANDO capsules for oral administration are available containing 112.5 mg of testosterone undecanoate. The capsules have a white opaque body imprinted with “112” in black ink and a grey opaque cap, banded with a colorless band. TLANDO capsules are supplied in HDPE bottles with a foil liner and a child resistant cap.
Bottles of 120 capsules: NDC 74676-0112-2. Store at 20ºC to 25°C (68ºF to 77°F); excursions permitted to 15ºC to 30°C (59ºF to 86°F). [See USP Controlled Room Temperature]. Dispose of unused TLANDO via a take-back option.
If a take-back option is unavailable, follow FDA instructions at www.fda.gov/drugdisposal.
📋 Description ▾
11 DESCRIPTION TLANDO (testosterone undecanoate) capsules contain 112.5 mg testosterone undecanoate, an ester of testosterone, for oral administration. Testosterone, an androgen, is formed by cleavage of the ester side chain of testosterone undecanoate. The chemical name of testosterone undecanoate is 17β-undecanoyloxy-4-androsten-3-one.
It has an empirical formula of C 30 H 48 O 3 and a molecular weight of 456.7. The structural formula is: Testosterone undecanoate is a white to off-white crystalline substance. The inactive ingredients in TLANDO capsules are ascorbyl palmitate, glyceryl monolinoleate, polyethylene glycol 8000, and polyoxyl 40 hydrogenated castor oil.
The capsule shell contains black iron oxide, gelatin, and titanium dioxide. The capsule is imprinted with black ink that contains ammonium hydroxide, black iron oxide, propylene glycol, and shellac. Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patients to read the FDA-approved patient labeling ( Medication Guide ). Polycythemia Advise patients that TLANDO can cause an increase in hematocrit levels that may increase the risk of thromboembolic events. Advise patients about the importance of completing laboratory testing as instructed by their health care provider while on TLANDO [see Warnings and Precautions ( 5.1 )].
Venous Thromboembolism Advise patients that TLANDO can cause venous thromboembolism. Advise patients of the signs and symptoms of venous thromboembolism, which may include the following: lower limb pain, edema, or erythema; and dyspnea or chest pain. Advise patients to promptly report the signs and symptoms of venous thromboembolism, discontinue use of TLANDO and seek urgent medical care [see Warnings and Precautions ( 5.2 )] .
Blood Pressure Increases Advise patients that TLANDO can increase blood pressure (BP) which can increase cardiovascular risk over time. Advise patients about the importance of monitoring BP periodically while on TLANDO. If BP increases while on TLANDO, antihypertensive medications may need to be started, added, or adjusted to control BP, or TLANDO may need to be discontinued [see Warnings and Precautions ( 5.4 )] .
Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer Advise patients that TLANDO can cause increased symptoms of BPH and can increase the risk for prostate cancer. Advise patients to contact their health care provider if they have any prostate-related symptoms [see Warnings and Precautions ( 5.3 )]. Edema Advise patients with preexisting cardiac, renal, or hepatic disease that TLANDO can cause edema.
Advise patients to notify their health care provider if edema develops or worsens [see Warnings and Precautions ( 5.10 )]. Sleep Apnea Advise patients that TLANDO can worsen sleep apnea especially in patients with risk factors such as obesity or chronic lung diseases [see Warnings and Precautions ( 5.11 )]. Gynecomastia Advise patients that TLANDO can cause gynecomastia. [see Warnings and Precautions ( 5.12 )].
Administration Instructions Advise patients to take TLANDO with food [see Dosage and Administration ( 2.3 )]. Verity Pharma Medical Affairs: 1-844-VERITY-1 (1-844-837-4891) Manufactured for: Manufactured for Verity Pharmaceuticals, Inc. Ewing, NJ 08628 TLANDO® and its design are registered trademarks of Verity Pharmaceuticals Inc.
Verity Pharmaceuticals, Verity Pharma, and their designs are trademarks of Verity Pharmaceuticals, Inc. © 2026 Verity Pharmaceuticals Inc. All rights reserved. TLA-075
💬 Medication Guide ▾
This Medication Guide has been approved by the U.S. Food and Drug Administration Issued: 02/2026 MEDICATION GUIDE TLANDO ® (Tee-lan-doh) (testosterone undecanoate) capsules, for oral use CIII What is TLANDO? TLANDO is a prescription medicine that contains testosterone.
TLANDO is used to treat adult men who have low or no testosterone due to certain medical conditions. It is not known if TLANDO is safe or effective in children younger than 18 years old. Improper use of TLANDO may affect bone growth in children.
TLANDO is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your TLANDO in a safe place to protect it. Never give your TLANDO to anyone else, even if they have the same symptoms you have.
Selling or giving away this medicine may harm others and is against the law. TLANDO is not meant for use by women. Do not take TLANDO if you: have breast cancer. have or might have prostate cancer. are a woman who is pregnant.
TLANDO may harm your unborn baby. are allergic to TLANDO or any ingredients in TLANDO. See the end of this Medication Guide for a complete list of ingredients in TLANDO. have low testosterone without certain medical conditions. For example, do not take TLANDO if you have low testosterone due to age.
Before you take TLANDO, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure or are being treated for high blood pressure. have heart problems. have high red blood cell count (hematocrit) or high hemoglobin laboratory value. have urinary problems due to an enlarged prostate. have liver or kidney problems. have a history of mental health illness including suicidal thoughts or actions, depression, anxiety or mood disorder. have problems breathing while you sleep (sleep apnea).
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using TLANDO with certain other medicines can affect each other. Especially, tell your healthcare provider if you take: insulin. medicines that decrease blood clotting (blood thinners). corticosteroids. medicines that increase blood pressure such as some cold medicines and pain medicines.
Know the medicines you take. Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I take TLANDO? Take TLANDO exactly as your healthcare provider tells you take it. Take TLANDO by mouth two times daily.
Take 2 capsules in the morning and take 2 capsules in the evening. Take TLANDO with food. What are the possible side effects of TLANDO?
TLANDO may cause serious side effects including: See “ What is the most important information I should know about TLANDO?” Increase in red blood cell count (hematocrit) or hemoglobin. TLANDO increases red blood cell counts in some people. High red blood cell counts increase the risk of blood clots, strokes, and heart attacks.
You may need to stop TLANDO if your red blood cell count increases. Your healthcare provider should check your red blood cell count and hemoglobin while you use TLANDO. If you already have an enlarged prostate, your signs and symptoms may worsen while using TLANDO.
These may include: increased urination at night trouble starting your urine stream urinating many times during the day urge to go to the bathroom right away a urine accident inability to pass urine or weak urine flow Increased risk of prostate cancer . Your healthcare provider should check you for prostate cancer or any other prostate problems before you start and while you use TLANDO. Blood clots in the legs or lungs .
Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain. Increas…