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AZMIRO TESTOSTERONE CYPIONATE 200 mg/mL Injection, Solution, 1 vial — NDC 24338-0056-01 package photo

AZMIRO TESTOSTERONE CYPIONATE 200 mg/mL Injection, Solution, 1 vial

by Azurity Pharmaceuticals, Inc. · 1 VIAL in 1 CARTON (24338-056-01) / 1 mL in 1 VIAL
NDC 24338-0056-01
🏷️ FDA NDC (as labeled) 24338-056-01 billing pads the product segment with a zero
Rx only Brand On market CIII
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Testosterone Cypionate (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 10, 2025 — cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials. (Eugia US LLC) · FDA recall D-0363-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 24338-056-01
Product NDC 24338-056
11-digit billing NDC 24338005601
RxCUI 2047882, 2694309, 2694316, 2694320
UNII M0XW1UBI14
UPC 0324338055014
Application # NDA216318
SPL Set ID 235b5625-570d-3fba-e063-6394a90aa2d1
Established class (EPC) Androgen
Mechanism of action Androgen Receptor Agonists
Chemical class Androstanes
DEA schedule CIII
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-10-04
Route INTRAMUSCULAR
Dosage form INJECTION, SOLUTION
Substance TESTOSTERONE CYPIONATE
Why two NDCs? The FDA registers this code as 24338-056-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 24338-0056-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Androgen class.

Pharmacologic class Androgen
Drug family (ATC) 3-oxoandrosten (4) derivatives, Androgens and estrogens
How it works Androgen Receptor Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAzurity Pharmaceuticals, Inc.
Application holderAZURITY PHARMACEUTICALS INC
FDA applicationNDA216318 (NDA)
Labeler code24338
First marketedOct 2024
DEA scheduleCIII
Product typeHuman Prescription Drug
Portfolio57 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Testosterone injection is used to treat low or no testosterone levels, stimulate puberty in males with delayed puberty, and certain types of breast cancer. Testosterone is in a class of medications called androgenic hormones. Testosterone is a male sex hormone responsible for development and functioning of male sexual organs and typical male characteristics. Testosterone injection works by replacing the testosterone that is normally produced naturally in the body. When used to treat breast cancer, testosterone works by stopping the release of estrogen.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • 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?
📖 Read our full Testosterone guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 20 mg / 1 mL UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • 0.2 mL / 1 mL UNII N863NB338G
    Benzyl benzoate is a liquid organic compound used as a solvent and preservative in medicines. It helps dissolve active ingredients and can extend shelf life by preventing microbial growth in liquid formulations.
  • 542 mg / 1 mL UNII H3E878020N
    Cottonseed oil is a natural vegetable oil extracted from cotton plant seeds. It is used in medicines as a solvent and lubricant to help dissolve active ingredients and allow smooth tablet or capsule movement through manufacturing equipment.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J1072 $1.296 / J1072 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🧾 Billing & reimbursement

FDA NDC (as labeled)24338-056-01
11-digit billing NDC24338-0056-01
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ1072
Descriptor1 MG
Billing units / pkg200 units
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
testosterone cypionate 200 mg/mL 47781-0910-91 Alvogen 10 vials $2.235 AO Availability likely —
Testosterone Cypionate 200 mg/mL 62756-0016-40 Sun 1 vial $3.286 — FDA listed —
Testosterone Cypionate 200 mg/mL 00143-9726-01 Hikma 10 ml $3.651 AO Availability likely —
Testosterone Cypionate 200 mg/mL 00143-9005-01 Hikma 1 vial $3.651 AO Availability likely —
testosterone cypionate 200 mg/mL 70700-0290-22 Xiromed 1 vial $3.651 AO Availability likely —
Testosterone Cypionate 200 mg/mL 62756-0015-40 Sun 1 vial $11.349 — FDA listed —
Testosterone Cypionate 200 mg/mL 00143-9659-01 Hikma 1 ml $11.546 AO Availability likely —
Testosterone Cypionate 200 mg/mL 00409-6562-01 Hospira, 1 vial $11.546 AO Availability likely —
Testosterone Cypionate 200 mg/mL 00574-0820-01 Padagis 1 vial $11.546 AO Availability likely —
Testosterone Cypionate 200 mg/mL 00574-0827-01 Padagis 1 vial $11.546 AO Availability likely —
testosterone cypionate 200 mg/mL 47781-0911-93 Alvogen 1 vial $11.546 AO Availability likely —
Testosterone Cypionate 200 mg/mL 52536-0625-01 Wilshire 1 vial $11.546 AO Availability likely —
Testosterone Cypionate 200 mg/mL 55150-0277-01 Eugia 1 vial $11.546 AO Availability likely —
Testosterone Cypionate 200 mg/mL 69097-0537-31 Cipla 1 ml $11.546 AO Availability likely —
Testosterone Cypionate 200 mg/mL 69097-0802-32 Cipla 1 vial $11.546 AO Availability likely —
testosterone cypionate 200 mg/mL 70700-0289-22 Xiromed 1 vial $11.546 AO Availability likely —
testosterone cypionate 200 mg/mL 72603-0286-01 NorthStar 1 vial $11.546 AO Availability likely —
Depo-Testosterone 200 mg/mL 00009-0086-01 Pharmacia 1 vial $14.140 AO Availability likely —
Depo-Testosterone 200 mg/mL 00009-0417-01 Pharmacia 1 vial $14.140 AO Availability likely —
Testosterone Cypionate 200 mg/mL 00517-1830-01 American 1 vial $14.181 AO Discontinued —
Azmiro 200 mg/mLthis 24338-0056-01 Azurity 1 vial — — FDA listed —
testosterone cypionate 200 mg/mL 50090-7584-00 A-S 1 vial — AO FDA listed —
testosterone cypionate 200 mg/mL 50090-7585-00 A-S 1 vial — AO FDA listed —
Testosterone Cypionate 200 mg/mL 63629-8705-01 Bryant 1 vial — AO FDA listed —
testosterone cypionate 200 mg/mL 68071-3835-01 NuCare 1 vial — AO FDA listed —
Testosterone Cypionate 200 mg/mL 70518-4538-00 REMEDYREPACK 1 ml — AO FDA listed —
Testosterone Cypionate 200 mg/mL 71205-0289-01 Proficient 1 ml — AO FDA listed —
Testosterone Cypionate 200 mg/mL 71335-2470-01 Bryant 1 vial — AO FDA listed —
Testosterone Cypionate 200 mg/mL 71335-2838-01 Bryant 1 vial — AO FDA listed —
Testosterone Cypionate 200 mg/mL 72162-1119-02 Bryant 1 vial — AO FDA listed —
Testosterone Cypionate 200 mg/mL 72162-2348-02 Bryant 1 vial — AO FDA listed —
Testosterone Cypionate 200 mg/mL 72162-2375-02 Bryant 1 vial — AO FDA listed —
Testosterone Cypionate 200 mg/mL 76420-0746-01 Asclemed 1 vial — AO FDA listed —
testosterone cypionate 200 mg/mL 76420-0747-01 Asclemed 1 vial — AO FDA listed —
Testosterone Cypionate 200 mg/mL 63187-0647-10 Proficient 10 ml — AO FDA listed —
Testosterone Cypionate 200 mg/mL 76420-0065-10 Asclemed 10 ml — AO FDA listed —
Testosterone Cypionate 200 mg/mL 63629-8706-01 Bryant 1 vial — AO FDA listed —
Testosterone Cypionate 200 mg/mL 76420-0645-10 Asclemed 1 vial — AO FDA listed —
Testosterone Cypionate 200 mg/mL 76420-0741-10 Asclemed 1 vial — AO FDA listed —
Azmiro 200 mg/mL 24338-0055-01 Azurity 1 syringe — — FDA listed —
testosterone cypionate 200 mg/mL 68071-3840-01 NuCare 10 vials — AO FDA listed —
Testosterone Cypionate 200 mg/mL 50090-4147-00 A-S 1 vial — AO FDA listed —
Testosterone Cypionate 200 mg/mL 50090-7435-00 A-S 1 vial — AO FDA listed —
Testosterone Cypionate 200 mg/mL 68071-3809-01 NuCare 1 vial — AO FDA listed —
Testosterone Cypionate 200 mg/mL 50090-4920-00 A-S 1 vial — AO FDA listed —
testosterone cypionate 200 mg/mL 76420-0752-10 Asclemed 1 vial — AO FDA listed —
Testosterone Cypionate 200 mg/mL 71335-2473-01 Bryant 1 vial — AO FDA listed —
Testosterone Cypionate 200 mg/mL 87063-0272-10 ASCLEMED 1 vial — AO FDA listed —
testosterone cypionate 200 mg/mL 82983-0425-01 Ajenat 1 vial — — FDA listed —
testosterone cypionate 200 mg/mL 82983-0424-01 Ajenat 1 vial — — FDA listed —
testosterone cypionate 200 mg/mL 54288-0150-01 BPI 1 vial — — FDA listed —
testosterone cypionate 200 mg/mL 54288-0156-01 BPI 1 vial — — FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2022
First FDA approval
Jun 2022
📍
2026
Currently FDA-listed
4 years listed
🛡️
2039
Latest patent/protection listed
not a guaranteed launch date
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Mar 2039. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jun 2, 2022 RLD RS ⏳ ~12.5 yr to latest listed protection

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.

Patents & exclusivity — FDA Orange Book
US 12138271 — drug product
US 11642355 — drug product
US 11311554 — drug product
2022 2024 2026 2028 2030 2032 2034 2036 2038
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 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.

Listed patents (3)
PatentTypeUse codeExpires
US 12138271 ↗ Drug product — Mar 25, 2039
US 11642355 ↗ Drug product — Mar 25, 2039
US 11311554 ↗ Drug product — Mar 25, 2039
Common questions
Is there a generic version of this drug?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for this drug. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Azmiro — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Azmiro. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$11.8K
Claims incl. refills
23
Beneficiaries
14
Spend / beneficiary
$841.92
Spend / claim
$512.47
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for AZMIRO (this brand).

Top reported reactions

Fatigue359
Product Deposit267
Pain242
Liquid Product Physical Issue236
Injection Site Pain232
Poor Quality Product Administered216
Headache191

Age at onset

Adolescent14
Adult530
Elderly181

Reporter sex

5,804 reports
Male · 90%
Female · 9%
Unknown · 0%

Serious outcomes

Hospitalization1,220
Disabling206
Death190
Life-threatening110
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 444 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
24338-0056-01 You're viewing this 1 VIAL in 1 CARTON (24338-056-01) / 1 mL in 1 VIAL 2024-10-04 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 24338-056-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 24338-0056-01, written without dashes as 24338005601. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 24338-0056-01, the first segment (24338) is the labeler code FDA assigned to Azurity Pharmaceuticals, Inc.; the middle segment (0056) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Azurity Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Azurity Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J1072 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS & USAGE AZMIRO is indicated for testosterone replacement therapy in males in 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; or orchiectomy, Klinefelter’s syndrome, or toxic damage from alcohol or heavy metals, 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 AZMIRO in men with “age- related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established. • Safety and efficacy of AZMIRO in pediatric patients below the age of 12 years have not been established [ see Use in Specific Populations ( 8.4 ) ]. AZMIRO is an androgen indicated for testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone ( 1 ): Limitations of Use: • Safety and efficacy of AZMIRO in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established ( 1 ). • Safety and effectiveness in pediatric patients below the age of 12 years have not been established ( 8.4 ).

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Injectable testosterone products may have different doses, strengths, or administration instructions and they are not substitutable on a milligram-per-milligram basis. Administer AZMIRO by deep gluteal intramuscular injection only ( 2.1 ). • Prior to initiating AZMIRO, 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 concentrations are below the normal range ( 2.2 ). • Recommended dosage is 50 mg to 400 mg administered every two to four weeks as a deep intramuscular injection in the gluteal muscle.

Individualize the dose and schedule based on the patient’s age, diagnosis, response to treatment, and the appearance of adverse reactions ( 2.3 ). • The prefilled syringe should be administered as an intramuscular injection by a healthcare professional only.

2.1Important Dosage Information • Injectable testosterone products may have different doses, strengths, or administration instructions and they are not substitutable on a milligram-per-milligram basis. • Administer AZMIRO by deep gluteal intramuscular injection only.

2.2Confirmation of Hypogonadism before Initiation of AZMIRO Prior to initiating AZMIRO, 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 AZMIRO is 50 mg to 400 mg administered every two to four weeks as a deep intramuscular injection in the gluteal muscle. Individualize the dose and schedule of AZMIRO based on the patient’s age, diagnosis, response to treatment, and the appearance of adverse reactions.

2.4Administration Instructions for AZMIRO Single-dose Vial • Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. • Discard any unused portions of drug remaining in the single-dose vial.

2.5Important Administration Information and Administration Instructions for AZMIRO Prefilled Syringe Important Administration Information • The prefilled syringe should be administered as an intramuscular injection by a healthcare professional only. • The prefilled syringe should only be used to administer doses of 200 mg. For administration of doses other than 200 mg, use the AZMIRO single-dose vial. • AZMIRO 200 mg/mL is supplied as single-dose prefilled syringe with luer lock connector. • The prefilled syringe carton does not contain a needle.

Obtain suitable needle separately. • Do not use if the packaging appears to be damaged. • Do not use the prefilled syringe if it appears to be damaged or the syringe cap is detached from the Luer lock. Administration Instructions Hold the syringe upright while gripping the ribbed part of the luer lock. Then with the other hand unscrew the syringe cap in a counter-clockwise direction (Figure A).

Once the syringe cap is removed, avoid any hand contact with the tip of the glass syringe, to maintain the sterility. • Screw the needle onto the luer lock end of the syringe in a clockwise direction until it is firmly attached (Figure B). • Remove the needle cap by pulling it straight off. • Check syringe for air bubbles. If there are air bubbles: Gently tap the syringe with your fingers until the bubbles rise to the top of the syringe. Then press the plunger up to slowly expel the air. • Clean the injection site for injection into the gluteal muscle with an alcohol swab and allow the skin to dry. • Insert the needle straight into the skin at a 90° angle (Figure C).

Push the plunger down to inject the entire contents (1 mL) of the prefilled syringe (Figure D). • After administration of the injection, discard the syringe into a sharps disposal container or in accordance with local requirements (Figure E). Figure-A Figure-B Figu…

💊 Dosage Forms and Strengths 67 words ▾

3 DOSAGE FORMS & STRENGTHS Injection: • 200 mg/mL available as 1 mL of clear colorless to pale yellow solution filled in a single-dose glass vial. • 200 mg/mL available as 1 mL of clear colorless to pale yellow solution filled in a single-dose glass prefilled syringe. Injection: 200 mg/mL in a single-dose vial ( 3 ) 200 mg/mL in a single-dose prefilled syringe ( 3 )

⛔ Contraindications 146 words ▾

4 CONTRAINDICATIONS AZMIRO is contraindicated in: • Known hypersensitivity to AZMIRO or to any of its components [see Description ( 11 )]. Hypersensitivity, including skin manifestations and anaphylactoid reactions have been reported [ see Adverse Reactions ( 6.2 ) ]. • Men with carcinoma of the breast or known or suspected carcinoma of the prostate gland [ 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 AZMIRO or any of its components, skin manifestations and anaphylactoid reactions have been reported ( 4 ) • Men with carcinoma of the breast or known or suspected carcinoma of the prostate ( 4 ). • Women who are pregnant.

Testosterone may cause fetal harm ( 4 ).

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Polycythemia : Monitor hematocrit periodically during treatment. Discontinue AZMIRO, 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 AZMIRO 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 : Testosterone 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 : AZMIRO may cause azoospermia ( 5.7 , 8.3 ). • Edema : Edema, with or without congestive heart failure (CHF), may occur in patients with pre-existing cardiac, renal, or hepatic disease.

Discontinue AZMIRO and initiate appropriate workup ( 5.9 ). • Sleep Apnea : AZMIRO 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 AZMIRO ( 5.12 ). • Adverse Effects on Bone Maturation : Testosterone may result in acceleration of bone age and premature closure of epiphyses in pediatric patients which may result in compromised adult stature.

Monitor the effect on bone maturation by assessing bone age of the wrist and hand every 6 months.

5.1Polycythemia Increases in hematocrit levels, reflective of increases in red blood cell mass, may require discontinuation of AZMIRO. Check that hematocrit is not elevated prior to initiating AZMIRO. Periodically monitor hematocrit levels during treatment.

If hematocrit becomes elevated, stop AZMIRO until hematocrit decreases to an acceptable concentration. If AZMIRO is restarted and again causes hematocrit to become elevated, stop AZMIRO permanently. An increase in red blood cell mass may increase the risk of thromboembolic events [ see Warnings and Precautions ( 5.2 ) ].

5.2Venous Thromboembolism (VTE) There have been postmarketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone replacement products, such as AZMIRO. 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 treatment with AZMIRO 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 with androgens may be at inc…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS 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 ) ] • Adverse Effects on Bone Maturation [ see Warnings and Precautions ( 5.16 ) ] Common adverse reactions (incidence ≥4%) are injection site erythema and injection site reaction ( 6.1 ).

Other adverse reactions include: polycythemia, gynecomastia, headache, and depression ( 6.2 ). To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 AZMIRO was evaluated, in Study 1, a randomized, single-dose, open-label study conducted in 27 adult males with hypogonadism. Patients were 18 to 65 years of age with a body mass index of 18 to 35 kg/m 2 .

Patients received a single intramuscular dose AZMIRO 200 mg or comparator intramuscular testosterone replacement therapy product and were observed for adverse reactions and injection site reactions over 31 days. The most common adverse reactions in patients who received AZMIRO were injection site erythema (26%) and injection site reaction (4%). All cases of injection site erythema and injection site reaction were categorized as mild based on a pre-defined injection site assessment scale that defined injection site reactions as mild if they were slight or barely perceptible.

Cardiovascular Outcomes TRAVERSE was a randomized, double-blind, cardiovascular outcomes study to assess the cardiovascular (CV) safety of topical testosterone gel compared to placebo in 5198 hypogonadal men aged 45 to 80 years with a history of CV disease or with multiple CV risk factors. The primary outcome was the incidence of the composite endpoint of major adverse cardiovascular events (MACE), consisting of CV death, non-fatal myocardial infarction (MI), and non-fatal stroke The mean duration of therapy was approximately 22 months.

The mean duration of follow-up was 33 months. Approximately 61% of all patients discontinued topical testosterone gel or placebo therapy. The mean patient age (±SD) was 63.3 (7.9) years, with 2452 patients aged 65 years or more (47%); 2847 (about 55%) patients had pre-existing cardiovascular disease, whereas 2357 patients (about 45%) had an elevated cardiovascular risk at baseline, and mean BMI was 35 kg/m 2 .

Approximately 80% of patients were White, 17% were Black, and 3% were of other races or ethnic groups. Approximately 69%, 84%, and 93% had diabetes mellitus, hyperlipidemia, and hypertension, respectively. The mean serum testosterone concentration at baseline in patients receiving topical testosterone gel was 220.4 ng/dL (n=2596).

The mean serum testosterone concentrations at 12 months, 24 months, 36 months, and 48 months in patients receiving topical testosterone gel were 440.5 ng/dL (n=1683), 420.9 ng/dl (n=1125), 428.7 ng/dL (n=731), and 365.2 ng/dL (n=220), respectively. For patients tr…

🔄 Drug Interactions 170 words ▾

7 DRUG INTERACTIONS • Insulin: In patients with diabetes, concomitant use with AZMIRO may decrease blood glucose and insulin requirements ( 7.1 ). • Oral Anticoagulants: Concomitant use with AZMIRO may cause changes in anticoagulant activity. Monitor International Normalized Ratio and prothrombin time frequently ( 7.2 ). • Corticosteroids: Concomitant use with AZMIRO may result in increased fluid retention. Use with caution, particularly in patients with cardiac, renal, or hepatic disease ( 7.3 ).

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.

👥 Use in Specific Populations ~2 min read ▾

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 prostatic carcinoma ( 8.5 ).

8.1Pregnancy Risk Summary AZMIRO 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 AZMIRO 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 AZMIRO, spermatogenesis may be suppressed through feedback inhibition of the hypothalamic-pituitary-testicular-axis [ see Warnings and Precautions ( 5.7 ) ]. 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 Improper use may result in acceleration of bone age and premature closure of epiphyses. The effect on bone maturation should be monitored by assessing bone age of the wrist and hand every 6 months. In children, androgen treatment may accelerate bone maturation without producing compensatory gain in linear growth.

This adverse effect may result in compromised adult stature. The younger the child the greater the risk of compromising final mature height. Precocious puberty has also been reported with use of testosterone.

The safety and effectiveness of AZMIRO have not been established in pediatric patients young than 12 years of age.

8.5Geriatric Use Geriatric patients treated with androgens may be at an increased risk of developing BPH and prostatic carcinoma [see Warnings and Precautions ( 5.3 )].

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary AZMIRO 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 103 words ▾

8.4Pediatric Use Improper use may result in acceleration of bone age and premature closure of epiphyses. The effect on bone maturation should be monitored by assessing bone age of the wrist and hand every 6 months. In children, androgen treatment may accelerate bone maturation without producing compensatory gain in linear growth.

This adverse effect may result in compromised adult stature. The younger the child the greater the risk of compromising final mature height. Precocious puberty has also been reported with use of testosterone.

The safety and effectiveness of AZMIRO have not been established in pediatric patients young than 12 years of age.

🧓 Geriatric Use 27 words ▾

8.5Geriatric Use Geriatric patients treated with androgens may be at an increased risk of developing BPH and prostatic carcinoma [see Warnings and Precautions ( 5.3 )].

🆘 Overdosage 46 words ▾

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 AZMIRO and appropriate symptomatic and supportive care.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include growth and maturation of the 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 The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of testosterone have not been fully characterized.

12.3Pharmacokinetics Absorption Testosterone esters are less polar than free testosterone. Testosterone esters in oil injected intramuscularly are absorbed slowly from the lipid phase; thus, AZMIRO can be given at intervals of two to four weeks. Pharmacokinetic parameters of baseline-corrected testosterone obtained following a single-dose intramuscular administration of AZMIRO 200 mg in prefilled syringe in 26 hypogonadal adult males are summarized in Table 1 below.

Table 1: Mean (±SD) Baseline-corrected Testosterone Pharmacokinetic Parameters Following a Single-dose Intramuscular Administration of AZMIRO 200 mg in Hypogonadal Males (N=26) Parameter Mean (±SD) AUC 0-t (hr·ng/dL) 137218.7 (±62360.0) C max (ng/dL) 758.0 (±288.7) T max (hr) 71.7 (24.0, 191.0) a a Reported in median (min, max). 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 half-life of AZMIRO when injected intramuscularly is approximately eight days. Metabolism Inactivation of testosterone occurs primarily in the liver. Testosterone is metabolized to various 17-keto steroids through two different pathways.

The major active metabolites of testosterone are dihydrotestosterone (DHT) and estradiol. Excretion About 90 percent of a dose of testosterone is excreted in the urine as glucuronic and sulfuric acid conjugates of testosterone and its metabolites. About 6 percent of a dose is excreted in the feces, mostly in the unconjugated form.

🧬 Mechanism of Action 119 words ▾

12.1Mechanism of Action Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include growth and maturation of the 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 71 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING AZMIRO (testosterone cypionate) injection is supplied as a sterile, clear colorless to pale yellow solution in single-dose vials and single-dose prefilled syringes as 200 mg/mL testosterone cypionate. NDC Number Package Size 24338-056-01 1 mL vials 24338-055-01 1 mL prefilled syringes Store at 15°C to 25°C (59°F to 77°F); excursions permitted to 2°C to 30°C (36°F to 86°F). Store product in carton to protect contents from light.

📋 Description 137 words ▾

11 DESCRIPTION AZMIRO (testosterone cypionate) injection for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils.

The chemical name for testosterone cypionate is androst-4-en-3-one, 17-(3-cyclopentyl-1-oxopropoxy)-, (17ß)-. Its molecular formula is C 27 H 40 O 3 , and the molecular weight 412.61. The structural formula is shown in the following figure: AZMIRO (testosterone cypionate) injection is provided as sterile, clear colorless to pale yellow solution containing 200 mg/mL testosterone cypionate in vials and prefilled syringes.

Each mL of solution contains: Testosterone cypionate………………………………………..200 mg Benzyl alcohol………………………………………………….20 mg Benzyl benzoate……………………………………………….0.2 mL Cottonseed oil…………………………………………………542 mg Testosteron structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Polycythemia Advise patients that AZMIRO 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 AZMIRO [ see Warnings and Precautions ( 5.1 ) ]. Venous Thromboembolism Advise patients that AZMIRO 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 AZMIRO, and seek urgent medical care. Increase in Blood Pressure Advise patients that AZMIRO can increase BP which can increase cardiovascular risk over time.

Instruct patients about the importance of monitoring BP periodically while on AZMIRO. If BP increases while on AZMIRO, antihypertensive medications may need to be started, added, or adjusted to control BP, or AZMIRO may need to be discontinued. Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer Advise patients that AZMIRO 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 AZMIRO can cause edema. Advise patients to notify their health care provider if edema develops or worsens [ see Warnings and Precautions ( 5.9 ) ].

Sleep Apnea Advise patients that AZMIRO can worsen sleep apnea especially in patients with risk factors such as obesity or chronic lung diseases [ see Warnings and Precautions ( 5.10 ) ]. Gynecomastia Advise patients that AZMIRO can cause gynecomastia [ see Warnings and Precautions ( 5.11 ) ]. Manufactured for: Azurity Pharmaceuticals, Inc.

Woburn, MA 01801 Manufactured by: LSNE-LEON SLU Calle nicostrato vela (pq. Tecchnologico leon), S/N – M1.1-M1.2, Leon, 24009, Spain (ESP) Patent: https://azurity.com/patents_and_trademarks/ This product's labeling may have been updated. For current Full Prescribing Information, please visit www.azmiro.com AZM-PI-01 Rev.

JULY2025

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 24338-0055-01 · Azurity 24338-0100-03 · Azurity →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.