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Testosterone Cypionate 200 mg/mL Injection, Solution, 1 vial

by American Regent, Inc. · 1 VIAL in 1 BOX (0517-1830-01) / 1 mL in 1 VIAL
NDC 00517-1830-01
🏷️ FDA NDC (as labeled) 0517-1830-01 billing pads the labeler segment with a zero
Rx only Generic Discontinued CIII ⚠ Discontinued by firm
🗂️ 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 ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Aug 2021. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 0517-1830-01
Product NDC 0517-1830
11-digit billing NDC 00517183001
NCPDP billing unit ML — per mL (volume)
RxCUI 2047882
UNII M0XW1UBI14
Application # ANDA207742
SPL Set ID 08f88e0e-d9a4-4a03-9286-46d9bf9a363e
Established class (EPC) Androgen
Mechanism of action Androgen Receptor Agonists
Chemical class Androstanes
DEA schedule CIII
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Aug 2021)
Marketing start 2019-07-19
Route INTRAMUSCULAR
Dosage form INJECTION, SOLUTION
Substance TESTOSTERONE CYPIONATE
GPI-14 23100030102015
GPI class Testosterone Cypionate
GCN Seq No 003148
GCN 10194
HICL code 001400
Ingredient (HICL) Testosterone Cypionate
HIC1 code F
Therapeutic class — broad (HIC1) Male Genital System
HIC2 code F1
Therapeutic class — intermediate (HIC2) Androgens
HIC3 code F1A
Therapeutic class — specific (HIC3) Androgenic Agents
AHFS code 68:08.00.00
AHFS class Androgens
FDB label name TESTOSTERONE CYP 200 MG/ML
FDB brand name Testosterone Cypionate
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AO · RLD · RS
Why two NDCs? The FDA registers this code as 0517-1830-01 — a 4-4-2 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 labeler segment → 00517-1830-01. 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

LabelerAmerican Regent, Inc.
Application holderAMERICAN REGENT INC
FDA applicationANDA207742 (ANDA)
Labeler code00517
First marketedJul 2019
DEA scheduleCIII
Product typeHuman Prescription Drug
Portfolio72 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

Label name TESTOSTERONE CYP 200 MG/ML Ingredient Testosterone Cypionate
📖 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 $14.181 $14.18 / 1 ml
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 · Q2 2026 $3.34 $3.34 / 1 ml
Medicare Part B allowsASP · J1071 $0.025 / J1071 unit —
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Apr 2022 Sep 2022 Feb 2024 $15.535 $13.915
▼ Down 7% over the last 15 months.
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)0517-1830-01
11-digit billing NDC00517-1830-01
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ1071
DescriptorINJECTION, TESTOSTERONE CYPIONATE, 1MG
Billing units / pkg200 units
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
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 save 84%
Testosterone Cypionate 200 mg/mL 62756-0016-40 Sun 1 vial $3.286 — FDA listed save 77%
Testosterone Cypionate 200 mg/mL 00143-9726-01 Hikma 10 ml $3.651 AO Availability likely save 74%
Testosterone Cypionate 200 mg/mL 00143-9005-01 Hikma 1 vial $3.651 AO Availability likely save 74%
testosterone cypionate 200 mg/mL 70700-0290-22 Xiromed 1 vial $3.651 AO Availability likely save 74%
Testosterone Cypionate 200 mg/mL 62756-0015-40 Sun 1 vial $11.349 — FDA listed save 20%
Testosterone Cypionate 200 mg/mL 00143-9659-01 Hikma 1 ml $11.546 AO Availability likely save 19%
Testosterone Cypionate 200 mg/mL 00409-6562-01 Hospira, 1 vial $11.546 AO Availability likely save 19%
Testosterone Cypionate 200 mg/mL 00574-0820-01 Padagis 1 vial $11.546 AO Availability likely save 19%
Testosterone Cypionate 200 mg/mL 00574-0827-01 Padagis 1 vial $11.546 AO Availability likely save 19%
testosterone cypionate 200 mg/mL 47781-0911-93 Alvogen 1 vial $11.546 AO Availability likely save 19%
Testosterone Cypionate 200 mg/mL 52536-0625-01 Wilshire 1 vial $11.546 AO Availability likely save 19%
Testosterone Cypionate 200 mg/mL 55150-0277-01 Eugia 1 vial $11.546 AO Availability likely save 19%
Testosterone Cypionate 200 mg/mL 69097-0537-31 Cipla 1 ml $11.546 AO Availability likely save 19%
Testosterone Cypionate 200 mg/mL 69097-0802-32 Cipla 1 vial $11.546 AO Availability likely save 19%
testosterone cypionate 200 mg/mL 70700-0289-22 Xiromed 1 vial $11.546 AO Availability likely save 19%
testosterone cypionate 200 mg/mL 72603-0286-01 NorthStar 1 vial $11.546 AO Availability likely save 19%
Depo-Testosterone 200 mg/mL 00009-0086-01 Pharmacia 1 vial $14.140 AO Availability likely +0%
Depo-Testosterone 200 mg/mL 00009-0417-01 Pharmacia 1 vial $14.140 AO Availability likely +0%
Testosterone Cypionate 200 mg/mLthis 00517-1830-01 American 1 vial $14.181 AO Discontinued —
Azmiro 200 mg/mL 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 —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2019
On the market since
Jul 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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 Testosterone Cypionate — the program that covers self-administered drugs. 12 manufacturers.
⚠️ 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 Testosterone Cypionate. 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
$11.24M
Claims incl. refills
320.7K
Beneficiaries
209.5K
Spend / beneficiary
$53.62
Spend / claim
$35.03
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 Testosterone cypionate — the ingredient across all brands.

Top reported reactions

Myocardial Infarction949
Cerebrovascular Accident684
Deep Vein Thrombosis622
Pulmonary Embolism558
Pain485
Fatigue478
Anxiety364

Age at onset

Adolescent15
Adult592
Elderly195

Reporter sex

0 reports
Male · 93%
Female · 6%
Unknown · 1%

Serious outcomes

Hospitalization2,605
Disabling554
Death386
Life-threatening143
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 481 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
00517-1830-01 You're viewing this 1 VIAL in 1 BOX (0517-1830-01) / 1 mL in 1 VIAL 2019-07-19 Discontinued by firm

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
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

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 0517-1830-01, 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: 00517-1830-01, written without dashes as 00517183001. 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 00517-1830-01, the first segment (00517) is the labeler code FDA assigned to American Regent, Inc.; the middle segment (1830) 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.
Who lists this product with the FDA?
American Regent, 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 J1071 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 ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🔄 Drug / Laboratory Test Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 83 words ▾

INDICATIONS AND USAGE Testosterone cypionate injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. 1. Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy.

2. Hypogonadotropic hypogonadism (congenital or acquired)-gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Safety and efficacy of testosterone cypionate injection in men with “age­-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION Prior to initiating testosterone cypionate injection, 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. Testosterone cypionate injection is for intramuscular use only. It should not be given intravenously.

Intramuscular injections should be given deep in the gluteal muscle. The suggested dosage for testosterone cypionate injection varies depending on the age, sex, and diagnosis of the individual patient. Dosage is adjusted according to the patient's response and the appearance of adverse reactions.

Various dosage regimens have been used to induce pubertal changes in hypogonadal males; some experts have advocated lower dosages initially, gradually increasing the dose as puberty progresses, with or without a decrease to maintenance levels. Other experts emphasize that higher dosages are needed to induce pubertal changes and lower dosages can be used for maintenance after puberty. The chronological and skeletal ages must be taken into consideration, both in determining the initial dose and in adjusting the dose.

For replacement in the hypogonadal male, 50 to 400 mg should be administered every two to four weeks. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Warming and shaking the vial should redissolve any crystals that may have formed during storage at temperatures lower than recommended.

⛔ Contraindications 47 words ▾

CONTRAINDICATIONS 1. Known hypersensitivity to the drug 2. Males with carcinoma of the breast 3. Males with known or suspected carcinoma of the prostate gland 4. Women who are pregnant (see PRECAUTIONS , Pregnancy ) 5. Patients with serious cardiac, hepatic or renal disease (see WARNINGS )

⚠️ Warnings ~3 min read ▾

WARNINGS Hypercalcemia may occur in immobilized patients. If this occurs, the drug should be discontinued. Prolonged use of high doses of androgens (principally the 17-α alkyl-androgens) has been associated with development of hepatic adenomas, hepatocellular carcinoma, and peliosis hepatis —all potentially life-threatening complications.

Geriatric patients treated with androgens may be at an increased risk of developing prostatic hypertrophy and prostatic carcinoma although conclusive evidence to support this concept is lacking. There have been postmarketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone products, such as testosterone cypionate. 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 testosterone cypionate and initiate appropriate workup and management. Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (MACE), such as non-fatal myocardial infarction, non-­fatal stroke, and cardiovascular death, with the use of testosterone compared to non-use.

Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. Patients should be informed of this possible risk when deciding whether to use or to continue to use testosterone cypionate injection. Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids.

Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions (see DRUG ABUSE AND DEPENDENCE ). If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives.

Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events. Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal or hepatic disease.

Gynecomastia may develop and occasionally persists in patients being treated for hypogonadism. The preservative benzyl alcohol has been associated with serious adverse events, including the “gasping syndrome”, and death in pediatric patients. Although normal therapeutic doses of this product ordinarily deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the “gasping syndrome”, the minimum amount of benzyl alcohol at which toxicity may occur is not known.

The risk of benzyl alcohol toxicity depends on the quantity administered and the liver and kidneys' capacity to detoxify the chemical. Premature and low-birth weight infants may be more likely to develop toxicity. Androgen therapy should be used cautiously in healthy males with delayed puberty.

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. This drug has not been shown to be safe and effective for…

🤒 Adverse Reactions 161 words ▾

ADVERSE REACTIONS The following adverse reactions in the male have occurred with some androgens: Endocrine and urogenital: Gynecomastia and excessive frequency and duration of penile erections. Oligospermia may occur at high dosages. Skin and appendages: Hirsutism, male pattern of baldness, seborrhea, and acne.

Cardiovascular disorders: myocardial infarction, stroke. Fluid and electrolyte disturbances: Retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates. Gastrointestinal: Nausea, cholestatic jaundice, alterations in liver function tests, rarely hepatocellular neoplasms and peliosis hepatis (see WARNINGS ).

Hematologic: Suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, and polycythemia. Nervous system: Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia. Allergic: Hypersensitivity, including skin manifestations and anaphylactoid reactions.

Vascular disorders: Venous thromboembolism Special senses: Rare cases of central serous chorioretinopathy (CSCR). Miscellaneous: Inflammation and pain at the site of intramuscular injection. To report SUSPECTED ADVERSE REACTIONS, contact American Regent, Inc. at 1-800-734-9236 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🔄 Drug Interactions 53 words ▾

Drug Interactions Androgens may increase sensitivity to oral anticoagulants. Dosage of the anticoagulant may require reduction in order to maintain satisfactory therapeutic hypoprothrombinemia. Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements.

🔄 Drug / Laboratory Test Interactions 45 words ▾

Drug/Laboratory Test Interferences Androgens may decrease levels of thyroxine-binding globulin, resulting in decreased total T 4 serum levels and increased resin uptake of T 3 and T 4 . Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.

🤰 Pregnancy 46 words ▾

Pregnancy Teratogenic Effects The use of testosterone in women who are pregnant is contraindicated. Testosterone is teratogenic and may cause fetal harm. Testosterone is known to cause virilization of the female fetus when administrated to pregnant women. Benzyl alcohol can cross the placenta. See WARNINGS .

🧒 Pediatric Use 18 words ▾

Pediatric Use Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

🆘 Overdosage 12 words ▾

OVERDOSAGE There have been no reports of acute overdosage with the androgens.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Endogenous androgens 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; development of male hair distribution, such as beard, pubic, chest, and axillary hair; laryngeal enlargement, vocal cord thickening, and alterations in body musculature and fat distribution. Drugs in this class also cause retention of nitrogen, sodium, potassium, and phosphorous, and decreased urinary excretion of calcium.

Androgens have been reported to increase protein anabolism and decrease protein catabolism. Nitrogen balance is improved only when there is sufficient intake of calories and protein. Androgens are responsible for the growth spurt of adolescence and for eventual termination of linear growth, brought about by fusion of the epiphyseal growth centers.

In children, exogenous androgens accelerate linear growth rates, but may cause disproportionate advancement in bone maturation. Use over long periods may result in fusion of the epiphyseal growth centers and termination of the growth process. Androgens have been reported to stimulate production of red blood cells by enhancing production of erythropoietic stimulation factor.

During exogenous administration of androgens, endogenous testosterone release is inhibited through feedback inhibition of pituitary luteinizing hormone (LH). At large doses of exogenous androgens, spermatogenesis may also be suppressed through feedback inhibition of pituitary follicle stimulating hormone (FSH). There is a lack of substantial evidence that androgens are effective in fractures, surgery, convalescence, and functional uterine bleeding.

Pharmacokinetics Testosterone esters are less polar than free testosterone. Testosterone esters in oil injected intramuscularly are absorbed slowly from the lipid phase; thus, testosterone cypionate can be given at intervals of two to four weeks. Testosterone in plasma is 98 percent bound to a specific testosterone-estradiol binding globulin, and about 2 percent is free.

Generally, the amount of this sex-hormone binding globulin in the plasma will determine the distribution of testosterone between free and bound forms, and the free testosterone concentration will determine its half-life. 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. Inactivation of testosterone occurs primarily in the liver.

Testosterone is metabolized to various 17-keto steroids through two different pathways. The half-life of testosterone cypionate when injected intramuscularly is approximately eight days. In many tissues the activity of testosterone appears to depend on reduction to dihydrotestosterone, which binds to cytosol receptor proteins.

The steroid-receptor complex is transported to the nucleus where it initiates transcription events and cellular changes related to androgen action.

📦 How Supplied / Storage and Handling 41 words ▾

HOW SUPPLIED Testosterone Cypionate Injection, USP, 200 mg/mL is available as follows: 1 mL Vials NDC 0517-1830-01 Individually Packaged 10 mL Vials NDC 0517-1831-01 IndividuallyPackaged Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.

📦 Storage and Handling 16 words ▾

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.

📋 Description 127 words ▾

DESCRIPTION Testosterone Cypionate Injection, USP, 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)-, (17β)-. Its molecular formula is C 27 H 40 O 3 , and the molecular weight 412.61. The structural formula is represented below: Testosterone Cypionate Injection, USP is available as 200 mg/mL testosterone cypionate.

Each mL of the solution contains Testosterone Cypionate, 200 mg; Benzyl Benzoate, 0.2 mL; Cottonseed Oil, 560 mg; Benzyl Alcohol (as preservative), 9.45 mg. Structural Formula

💬 Information for Patients 29 words ▾

Information for Patients Patients should be instructed to report any of the following: nausea, vomiting, changes in skin color, ankle swelling, too frequent or persistent erections of the penis.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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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.