FDA-filed SPL labeling · retrieved through openFDA

Testosterone

Testosterone is a hormone replacement therapy used to treat low testosterone levels caused by primary or secondary hypogonadism in adult males.

Brand names JatenzoAndrodermAveedNatestoFortesta +11 more
Drug classes Androgen Receptor Agonists
Rx/OTC Schedule CIII Forms 9 Routes Intramuscular · Transdermal · Topical · Oral +3
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 49 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveJul 1, 2025
Clinical labels in scope 49
AvailabilityRx/OTC
Earliest approval/marketing year 1953
FDA-listed product records 443
Boxed warningYes
How we combine label and product data →
No current FDA shortage listed · checked Sep 19, 2026 🚨Recall on record · 5
Other forms & routes:
Testosterone at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Testosterone replacement therapy is a well-established treatment for men whose bodies cannot produce enough testosterone due to a medical condition. It's available in several forms — gels, injections, capsules, patches, and more — and which one is right depends on your specific situation and your prescriber's guidance. Like any hormone therapy, it carries real risks including blood clots, prostate effects, and blood pressure changes, so regular monitoring is an important part of staying safe on it.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert

IMPORTANT WARNING: Children and women can be accidentally exposed to testosterone through skin contact with gel application sites. Cases of children developing early puberty signs — including genital growth, pubic hair, increased aggression, and advanced bone development — have been reported after contact with men using testosterone gel. These effects can sometimes be irreversible. Children and women should not touch unwashed skin or uncovered areas where a man has applied testosterone gel. Always wash hands after applying, let the gel dry completely, and cover the area with clothing before contact with others.

Read the full warning on DailyMed →

📖 Testosterone: Patient Information Guide

A plain-language walkthrough of Testosterone — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Testosterone is approved for testosterone replacement therapy across a range of products and delivery methods. Supported conditions include:

  • Primary hypogonadism (congenital or acquired): testicular failure caused by conditions such as Klinefelter's syndrome, undescended testes, testicular torsion, infection, surgical removal, chemotherapy, or toxic damage from alcohol or heavy metals — supported across all listed products
  • Hypogonadotropic hypogonadism (congenital or acquired): failure of the hypothalamus or pituitary gland to signal testosterone production, due to hormone deficiency, tumors, trauma, or radiation — supported across all listed products
  • Delayed puberty in males: Testopel (subcutaneous pellets) may be used to stimulate puberty in carefully selected males with clearly delayed puberty
  • Safety and efficacy for age-related (late-onset) hypogonadism have not been established for AndroGel, Testim, Jatenzo, Kyzatrex, Natesto, Testosterone Cypionate, Depo-Testosterone, Testone CIK, Xyosted, and Testopel
⚙️How it works

Testosterone is the body's primary male androgen hormone. When natural production is too low — whether because the testes can't make it or because the brain isn't sending the right signals — testosterone replacement restores circulating hormone levels. This supports the normal function of male sex organs and maintains secondary sex characteristics like muscle mass, body hair distribution, voice depth, and bone density. The major active forms in the body are testosterone itself and its metabolite dihydrotestosterone (DHT).

💊How it's taken

How testosterone is taken varies significantly by product. Oral capsules (Jatenzo, Kyzatrex, Tlando) are taken with food, typically twice daily. Transdermal gels (AndroGel, Testim, Vogelxo) and the nasal gel (Natesto) are applied daily — gels to the shoulders/upper arms, Natesto three times a day inside the nose. Intramuscular and subcutaneous injections vary by product: some are given weekly, others every two to four weeks, and Aveed is given at longer intervals after the initial doses. Before starting any form, your prescriber will confirm your diagnosis with at least two morning blood tests. Always follow your prescriber's specific schedule and dosing instructions.

🤒Side effects — in detail

The most commonly reported side effects of testosterone therapy include:

  • Increased PSA (a prostate marker monitored by your doctor)
  • High blood pressure
  • Elevated red blood cell count (hematocrit/hemoglobin)
  • Mood changes — irritability, mood swings, aggression
  • Acne
  • Swelling (fluid retention)
  • Application or injection site reactions
  • Decreased sperm count

More serious reactions — including blood clots, stroke, heart attack, prolonged painful erections, or signs of sleep apnea — require prompt medical attention. Contact your doctor right away if any of these occur.

⚠️Warnings & precautions
  • Secondary exposure risk: Children and women who come into skin contact with testosterone gel can absorb it and develop serious hormonal effects. Keep gel-covered skin covered and washed before contact with others.
  • Blood clots (VTE): Testosterone use has been associated with deep vein thrombosis and pulmonary embolism. Watch for leg pain/swelling or sudden shortness of breath.
  • Blood pressure: Testosterone can raise blood pressure; it is not recommended for men with uncontrolled hypertension. Blood pressure should be monitored regularly.
  • Polycythemia: Testosterone can increase red blood cell production to unsafe levels, raising clot risk. Hematocrit is monitored before and during treatment.
  • Prostate effects: Men with BPH may experience worsening symptoms. All men should be evaluated for prostate cancer before and during therapy.
  • Fertility: Testosterone can suppress sperm production; this effect may be irreversible.
  • Sleep apnea: May worsen, especially in men who are obese or have chronic lung disease.
  • Flammability: Gel products contain alcohol and are flammable until completely dry.
🔀What it interacts with

Testosterone can interact with several medications — tell your prescriber about everything you take:

  • Insulin and diabetes medications: Testosterone may lower blood sugar, potentially reducing the amount of insulin or other diabetes medications you need; blood sugar should be monitored more closely
  • Blood thinners (anticoagulants, e.g., warfarin): Testosterone can alter how anticoagulants work, changing clotting time; more frequent INR monitoring is recommended, especially when starting or stopping testosterone
  • Corticosteroids and ACTH: Combining these with testosterone can increase fluid retention, which is especially risky for people with heart, kidney, or liver problems

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Do not use if you have breast cancer or known or suspected prostate cancer
  • Pregnant women must not use testosterone and must avoid skin contact with testosterone gel — it causes fetal harm
  • Women generally should not use these products; they are not indicated for women
  • Men with uncontrolled high blood pressure should not use testosterone gel (not recommended)
  • Men with heart, kidney, or liver disease need extra monitoring for fluid retention
  • Men who want to father children should discuss fertility risks before starting — reduced sperm count may be irreversible
  • Older adults may face higher risks of prostate problems and cardiovascular disease; long-term safety data are limited
  • Children under 18: Safety and efficacy are not established for most products; improper use can cause premature bone aging
  • Men with BPH (enlarged prostate) should be monitored for worsening urinary symptoms
  • Men at risk for sleep apnea (especially if obese or with lung disease) should be monitored
🚑If you take too much

There is at least one reported case of serious overdose with injectable testosterone, involving very high blood levels that were linked to a stroke. If you suspect someone has received too much testosterone, stop use, wash any gel application site thoroughly with soap and water, and seek medical care immediately. Treatment is supportive and based on symptoms.

📡Pharmacodynamics — effects in the body

Testosterone replacement raises circulating testosterone levels back into the normal range seen in healthy men. This supports the development and maintenance of male sex organs and secondary sex characteristics, including muscle and fat distribution, body hair, and bone development. It works by restoring the hormone that the testes or brain signaling system is not producing in sufficient amounts.

🔬Pharmacokinetics — how your body processes it

When testosterone gel is applied to the skin once daily, it is absorbed continuously over 24 hours, maintaining steady blood levels throughout the day. In the bloodstream, about 40% of testosterone is bound to a protein called sex hormone-binding globulin (SHBG), most of the rest is loosely bound to albumin, and only about 2% circulates freely. Testosterone is broken down primarily in the liver into active metabolites including estradiol and DHT, and about 90% is eventually excreted in the urine. After stopping the gel, blood levels return close to baseline within 48 to 72 hours.

📦How to store it

Testosterone Enanthate Injection should be stored at 20º to 25ºC (68º to 77ºF) . at low temperatures.

📄 Written from Testosterone’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

170

Supplements & herbs that interact with Testosterone

170 supplements and herbal products have documented interactions with Testosterone in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 5
  • Moderate · 129
  • Minor · 36
Every supplement checked against Testosterone — ranked by severity The full interaction hub: 5 major · 129 moderate · 36 minor · every one linked to its full report. Check Testosterone against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Testosterone — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is testosterone replacement therapy for — do I really need it?
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 hypogonadism) or a signaling problem in the brain (hypogonadotropic hypogonadism). Before you start, your doctor will confirm low testosterone with at least two blood tests done in the morning. It's not approved for testosterone decline that's just part of normal aging, since safety and effectiveness haven't been established for that use.
I use the gel — do I really need to worry about my kids or partner being exposed to 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 growth, genital changes, or aggressive behavior. To protect them, let the gel dry completely, cover the application area with clothing, and wash the area with soap and water before any skin-to-skin contact. If a child in your home shows any unexpected hormonal changes, tell your doctor right away.
What side effects are most likely to show up, and which ones should make me call my doctor?
The most common things people notice include a rise in PSA (a prostate marker), mood changes like irritability, acne, swelling, and higher red blood cell counts — your doctor will monitor these with regular blood tests. You should call your doctor right away if you have leg pain or swelling, sudden shortness of breath, chest pain, or signs of a stroke like slurred speech or sudden weakness. Also report worsening urinary symptoms or prolonged painful erections immediately.
Will testosterone therapy affect my ability to have children?
It can. Testosterone can suppress sperm production by interfering with the hormonal signals that drive it. Some men see sperm counts drop significantly, and in some cases this may not fully reverse after stopping treatment. If having children is something you're thinking about now or in the future, bring it up with your prescriber before starting therapy — there are options worth discussing.
Does it matter what time of day I take or apply testosterone?
Yes, timing matters and varies by product. Oral capsules like Jatenzo and Kyzatrex are typically taken twice a day — morning and evening — with food. Gels are usually applied once in the morning to the shoulders or upper arms. Natesto nasal gel is used three times a day. Injections are on a weekly or multi-week schedule depending on the product. Follow the specific schedule your prescriber gives you, and try to be consistent with the timing each day.
I take a blood thinner — is it safe to use testosterone?
You can use both, but you'll need closer monitoring. Testosterone can change how blood thinners like warfarin work, which affects your clotting time. Your doctor will likely check your INR (a clotting measure) more often when you start testosterone and if you ever stop it. Make sure every member of your care team knows about all the medications you're taking.
Is Testosterone available over the counter?
Both — Testosterone is sold both over the counter and by prescription, according to its FDA labeling. Lower strengths or certain forms are often available without a prescription, while higher strengths or specialized forms still require one. Ask your pharmacist which version is right for you.
Is Testosterone a controlled substance?
Yes — Testosterone is a federally controlled substance (Schedule III) in the United States, so how it is prescribed, refilled and dispensed is regulated by the DEA.
When was Testosterone first available?
Testosterone has been available in the United States since at least 1953, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Testosterone?
Testosterone is supplied by 92 manufacturers listed in the FDA NDC Directory, including Bryant Ranch Prepack, Actavis Pharma, Inc., Upsher-Smith Laboratories, LLC.

💬 Answers drafted from Testosterone’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Testosterone comes

Testosterone is available in 9 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

By injection · Into a muscle · Under the skin
Brands Aveed Azmiro Depo-Testosterone Testopel Testosterone Cypionate Xyosted
How this form is used
What it may be used for
  • Aveed is indicated for testosterone replacement therapy in adult males with primary or hypogonadotropic hypogonadism
  • Azmiro is indicated for testosterone replacement therapy in males with primary or hypogonadotropic hypogonadism
  • Depo-Testosterone and Testosterone Cypionate are indicated for replacement therapy in males with testosterone deficiency due to primary or hypogonadotropic hypogonadism
  • Testopel (subcutaneous pellets) is indicated for testosterone replacement and may also be used to stimulate puberty in carefully selected males with clearly delayed puberty
Important instructions
  • Aveed is given by deep intramuscular injection by a healthcare professional; patients must be observed for 30 minutes after each injection due to risk of serious reactions
  • Azmiro is administered by deep gluteal intramuscular injection only, by a healthcare professional, using a prefilled syringe
  • Injectable testosterone products have different doses and schedules and are not substitutable on a milligram-per-milligram basis — do not switch products without your prescriber's guidance
  • Testopel pellets are implanted subcutaneously by a healthcare professional
Available strengths 10 strengths
Show 4 more strengths Show fewer strengths
131 FDA-listed product records

Topical cream, ointment or gel

On the skin
Brands Fortesta Vogelxo
How this form is used
What it may be used for
  • Vogelxo is indicated for testosterone replacement therapy in adult males with primary or hypogonadotropic hypogonadism
Important instructions
  • Vogelxo is applied topically once daily at approximately the same time each day
  • Vogelxo is applied to clean, dry, intact skin of the shoulders and/or upper arms — do not apply to the genitals or abdomen
Available strengths 7 strengths
Show 1 more strength Show fewer strengths
55 FDA-listed product records

Topical (transdermal) gel

Through the skin
Brands AndroGel Testim
How this form is used
What it may be used for
  • AndroGel is indicated for testosterone replacement therapy in adult males with primary or hypogonadotropic hypogonadism
  • Testim is indicated for testosterone replacement therapy in adult males with primary or hypogonadotropic hypogonadism
Important instructions
  • AndroGel and Testim are applied to clean, dry, intact skin of the shoulders and/or upper arms once daily
  • Do not apply AndroGel or Testim to the genitals or abdomen
  • Wash hands after applying and keep the area covered with clothing before contact with others, especially children or pregnant women
  • AndroGel and Testim are flammable until dry — avoid fire, flame, or smoking until the gel has fully dried
Available strengths 7 strengths
Show 1 more strength Show fewer strengths
52 FDA-listed product records

Capsule

By mouth
Brands Jatenzo Kyzatrex Tlando
How this form is used
What it may be used for
  • Jatenzo is indicated for testosterone replacement therapy in adult males with primary or hypogonadotropic hypogonadism
  • Kyzatrex is indicated for testosterone replacement therapy in adult males with primary or hypogonadotropic hypogonadism
  • Tlando is indicated for testosterone replacement therapy in adult males with primary or hypogonadotropic hypogonadism
Important instructions
  • Jatenzo must be taken with food, twice daily (morning and evening)
  • Kyzatrex must be taken with food, twice daily (morning and evening)
  • Tlando must be taken with food; follow your prescriber's dosing schedule
  • Jatenzo and Kyzatrex are not interchangeable with each other or with other oral testosterone undecanoate products
Available strengths 8 strengths
Show 2 more strengths Show fewer strengths
29 FDA-listed product records

Topical solution

On the skin
Available strengths 1 strength
24 FDA-listed product records

Nasal topical

In the nose
Brands Natesto
How this form is used
What it may be used for
  • Natesto is indicated for testosterone replacement therapy in adult males with primary or hypogonadotropic hypogonadism
Important instructions
  • Natesto is applied inside the nose (one pump per nostril) three times daily
  • Natesto requires diagnosis confirmation with two morning testosterone blood tests below normal range before starting
  • Natesto is not established as safe or effective in males under 18 years old
Available strengths 1 strength
5 FDA-listed product records

Skin patch

Through the skin
Brands Androderm
How this form is used
What it may be used for
  • Androderm is a transdermal testosterone patch used for testosterone replacement therapy in males
Available strengths 2 strengths
4 FDA-listed product records

Tablet

By mouth
Available strengths 1 strength
1 FDA-listed product record

📊 Testosterone across the U.S. market

How Testosterone appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

9
Dose forms
92
Manufacturers
18
Brand names
443
FDA-listed product records
1953
First marketed

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (137) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack9%
Actavis Pharma, Inc.7%
Upsher-Smith Laboratories, LLC4%
A-S Medication Solutions4%
Padagis Israel Pharmaceuticals Ltd4%
Asclemed USA, Inc.4%
Other makers69%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Testosterone is used

A general measure of how commonly Testosterone is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Testosterone is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

731,644
Medicaid prescriptions filled (Q1–Q4 2025)
$50.7M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Testosterone prescribed? Of the 1,596 medications we measure, Testosterone ranks #213 by Medicaid prescriptions — more than 87% of them.

Where Testosterone ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Testosterone product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 1 mL / 200 mg/mL injection is the most-dispensed Testosterone product — about 71% of these Medicaid prescriptions.

1 ML testosterone cypionate 200 MG/ML Injection Most dispensed

517,489 Medicaid prescriptions (Q1–Q4 2025) 71% of Testosterone prescriptions shown $19.3M gross reimbursement (before rebates) ≈ $37 per prescription (gross)

Summed across the 12 of 30 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2047882

60 ACTUAT testosterone 20.25 MG/ACTUAT Topical Gel

88,516 Medicaid prescriptions (Q1–Q4 2025) 12% of Testosterone prescriptions shown $5.3M gross reimbursement (before rebates) ≈ $60 per prescription (gross)

Summed across the 9 of 22 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1597076

testosterone cypionate 200 MG/ML Injectable Solution

41,498 Medicaid prescriptions (Q1–Q4 2025) 6% of Testosterone prescriptions shown $825,713 gross reimbursement (before rebates) ≈ $20 per prescription (gross)

Summed across the 13 of 40 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 835840

5000 MG testosterone 0.01 MG/MG Topical Gel

18,470 Medicaid prescriptions (Q1–Q4 2025) 3% of Testosterone prescriptions shown $3M gross reimbursement (before rebates) ≈ $161 per prescription (gross)

Summed across the 7 of 27 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1597129

testosterone cypionate 100 MG/ML Injectable Solution

16,530 Medicaid prescriptions (Q1–Q4 2025) 2% of Testosterone prescriptions shown $626,229 gross reimbursement (before rebates) ≈ $38 per prescription (gross)

Summed across the 7 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 835829

0.5 ML testosterone enanthate 150 MG/ML Auto-Injector

8,140 Medicaid prescriptions (Q1–Q4 2025) 1% of Testosterone prescriptions shown $5.5M gross reimbursement (before rebates) ≈ $679 per prescription (gross)

Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2099695

testosterone enanthate 200 MG/ML Injectable Solution

7,776 Medicaid prescriptions (Q1–Q4 2025) 1% of Testosterone prescriptions shown $542,741 gross reimbursement (before rebates) ≈ $70 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 835809

0.5 ML testosterone enanthate 200 MG/ML Auto-Injector

7,659 Medicaid prescriptions (Q1–Q4 2025) 1% of Testosterone prescriptions shown $5.2M gross reimbursement (before rebates) ≈ $678 per prescription (gross)

Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2099681

60 ACTUAT testosterone 12.5 MG/ACTUAT Topical Gel

6,066 Medicaid prescriptions (Q1–Q4 2025) <1% of Testosterone prescriptions shown $836,678 gross reimbursement (before rebates) ≈ $138 per prescription (gross)

Summed across the 4 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1596780

0.5 ML testosterone enanthate 100 MG/ML Auto-Injector

4,599 Medicaid prescriptions (Q1–Q4 2025) <1% of Testosterone prescriptions shown $3.2M gross reimbursement (before rebates) ≈ $689 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2099689

2500 MG testosterone 0.01 MG/MG Topical Gel

4,162 Medicaid prescriptions (Q1–Q4 2025) <1% of Testosterone prescriptions shown $681,025 gross reimbursement (before rebates) ≈ $164 per prescription (gross)

Summed across the 3 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1597123

1250 MG testosterone 0.0162 MG/MG Topical Gel

3,240 Medicaid prescriptions (Q1–Q4 2025) <1% of Testosterone prescriptions shown $875,559 gross reimbursement (before rebates) ≈ $270 per prescription (gross)

Summed across the 2 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1597120

2500 MG testosterone 0.0162 MG/MG Topical Gel

3,156 Medicaid prescriptions (Q1–Q4 2025) <1% of Testosterone prescriptions shown $845,536 gross reimbursement (before rebates) ≈ $268 per prescription (gross)

Summed across the 3 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1597126

testosterone undecanoate 237 MG Oral Capsule

1,284 Medicaid prescriptions (Q1–Q4 2025) <1% of Testosterone prescriptions shown $1.3M gross reimbursement (before rebates) ≈ $1,038 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2121770

3 ML testosterone undecanoate 250 MG/ML Injection

940 Medicaid prescriptions (Q1–Q4 2025) <1% of Testosterone prescriptions shown $1.4M gross reimbursement (before rebates) ≈ $1,463 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1490661

testosterone undecanoate 158 MG Oral Capsule

571 Medicaid prescriptions (Q1–Q4 2025) <1% of Testosterone prescriptions shown $377,258 gross reimbursement (before rebates) ≈ $661 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2121766

testosterone undecanoate 198 MG Oral Capsule

560 Medicaid prescriptions (Q1–Q4 2025) <1% of Testosterone prescriptions shown $385,745 gross reimbursement (before rebates) ≈ $689 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2121768

testosterone 75 MG Drug Implant

496 Medicaid prescriptions (Q1–Q4 2025) <1% of Testosterone prescriptions shown $370,405 gross reimbursement (before rebates) ≈ $747 per prescription (gross)

Summed across the 2 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 318240

60 ACTUAT testosterone 30 MG/ACTUAT Topical Solution

331 Medicaid prescriptions (Q1–Q4 2025) <1% of Testosterone prescriptions shown $33,682 gross reimbursement (before rebates) ≈ $102 per prescription (gross)

Summed across the 3 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1599949

testosterone undecanoate 112.5 MG Oral Capsule

49 Medicaid prescriptions (Q1–Q4 2025) <1% of Testosterone prescriptions shown $40,256 gross reimbursement (before rebates) ≈ $822 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2599054

60 ACTUAT testosterone 5.5 MG/ACTUAT Nasal Gel

12 Medicaid prescriptions (Q1–Q4 2025) <1% of Testosterone prescriptions shown $8,597 gross reimbursement (before rebates) ≈ $716 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1596784

Other Testosterone products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

100 Medicaid prescriptions (Q1–Q4 2025) <1% of Testosterone prescriptions shown $23,653 gross reimbursement (before rebates) ≈ $237 per prescription (gross)

Summed across the 1 of 429 listed NDC products with Medicaid activity.

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Testosterone, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 76 of 635 listed Testosterone NDCs with Medicaid activity.

🔍 Compare Testosterone products

A representative set of FDA-listed product records for Testosterone — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 200 of 443 products — FDA National Drug Code Directory. See every product, package size and price: browse all 443 Testosterone NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Testosterone RxCUI 10379 12 dose forms · 38 strengths
  1. Dose form (SCDF) Buccal Film RxCUI 858105 No current FDA listing
    Clinical drug / strength (SCD) 30 MG RxCUI 858106
  2. Dose form (SCDF) Drug Implant RxCUI 378786 No current FDA listing
    Clinical drug / strength (SCD) 75 MG RxCUI 318240 100 MG RxCUI 250714 200 MG RxCUI 250244
  3. Dose form (SCDF) Injectable Suspension RxCUI 376305 In current FDA listings
    Clinical drug / strength (SCD) 50 MG/ML RxCUI 346968
  4. Dose form (SCDF) Transdermal System RxCUI 1806166 In current FDA listings
    Clinical drug / strength (SCD) 24 HR testosterone 0.0833 MG/HR RxCUI 1190953 24 HR testosterone 0.104 MG/HR RxCUI 199116 24 HR testosterone 0.167 MG/HR RxCUI 313233 24 HR testosterone 0.208 MG/HR RxCUI 313234 24 HR testosterone 0.25 MG/HR RxCUI 313235

Look up RxCUI 10379 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Jatenzo Androderm Aveed Natesto Fortesta Vogelxo Androgel Testim Xyosted Tlando Kyzatrex Undecatrex Azmiro Testopel Depo-Testosterone Testosterone Cypionate

🏭 Manufacturers & labelers

Bryant Ranch Prepack 31 Actavis Pharma, Inc. 24 Upsher-Smith Laboratories, LLC 13 A-S Medication Solutions 12 Padagis Israel Pharmaceuticals Ltd 12 Asclemed USA, Inc. 12 Jiangsu Jiaerke Pharmaceuticals Group Corp., Ltd 12 Antares Pharma, Inc. 11 Marius Pharmaceuticals 11 Cipla USA Inc. 10 Letco Medical, Llc 10 Northstar Rx LLC 9 TOLMAR Inc. 9 Pharmacia and Upjohn Company LLC 9 SCH Global Services Private Limited 9 Medisca Inc. 8 Symbiotec Pharmalab Limited 8 Hikma Pharmaceuticals USA Inc. 8 Pharmacia & Upjohn Company LLC 8 Alvogen Inc. 8 Eugia US LLC 7 Sun Pharmaceutical Industries, Inc. 7 zhejiang xianju pharmaceutical co., Ltd. 6 Endo Pharmaceuticals Inc. 6

…and 16 more on the FDA NDC directory.

RxNorm drug class

Testosterone belongs to the Androgen class.

Pharmacologic class Androgen
Drug family (ATC) 3-oxoandrosten (4) derivatives, Androgens and estrogens
How it works Androgen Receptor Agonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jul 1, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Testosterone.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Testosterone after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
49
NDC products indexed
443
Distinct labelers/manufacturers represented
92
Linked representative label
Antares Pharma, Inc.
Linked label effective
Jul 1, 2025
Composite sections available
30
Linked SPL Set ID
8a3d204c-be26-49e0-8599-0ac12a272e81
Linked SPL Document ID
c8d74eb6-fa94-446a-8307-091436a536dc
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 49 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Antares Pharma, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.