Home › NDC Lookup › Ingredients › Triptorelin › 24338-0150-20
TRIPTODUR triptorelin Kit — NDC 24338-0150-20 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

TRIPTODUR triptorelin Kit — NDC 24338-150-20 (Billing 24338-0150-20)

by Azurity Pharmaceuticals, Inc. · 1 KIT in 1 CARTON * 2 mL in 1 VIAL * 2 mL in 1 SYRINGE, GLASS

This is a package of TRIPTODUR triptorelin Kit from Azurity Pharmaceuticals, Inc., marketed since Sep 2017 and currently FDA-listed. It is this product's only package size.

NDC 24338-0150-20
🏷️ FDA NDC (as labeled) 24338-150-20 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 24338-150-20 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
24338 labeler · 150 product · 20 package
Package marketed since
Sep 8, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 2433815020 7
Medicaid fills, this package
940 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 24338-150-20
Product NDC 24338-150
11-digit billing NDC 24338015020
NCPDP billing unit EA — each (per item)
RxCUI 905053, 1944389
Application # NDA208956
SPL Set ID f41380e7-b830-432d-a5f5-a872932f107e
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-09-08
Dosage form KIT

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 3008007040G240
GPI class Triptodur
GCN Seq No 077557
GCN 43603
HICL code 023164
Ingredient (HICL) Triptorelin Pamoate
HIC1 code P
Therapeutic class — broad (HIC1) Endocrine System
HIC2 code P1
Therapeutic class — intermediate (HIC2) Anteriorpituitary Hormones
HIC3 code P1P
Therapeutic class — specific (HIC3) Lhrh(Gnrh)Agnst Pit.sup-Central Precocious Puberty
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name TRIPTODUR 22.5 MG KIT
FDB brand name Triptodur
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 077557
  • GCN: 43603
  • GPI-14 (Medi-Span): 3008007040G240
  • HICL (First Databank): 023164
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 905053
Why two NDCs? The FDA registers this code as 24338-150-20 — 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 → 24338-0150-20. 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 Gonadotropin Releasing Hormone Receptor Agonist class.

Pharmacologic class Gonadotropin Releasing Hormone Receptor Agonist
Drug family (ATC) Gonadotropin releasing hormone analogues
How it works Gonadotropin Releasing Hormone 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.

Clinical

Label name TRIPTODUR 22.5 MG KIT Ingredient Triptorelin Pamoate
📖 What it is MedlinePlus · NLM

Triptorelin injection is used to treat certain types of prostate cancer. It is also used to treat central precocious puberty (CPP; a condition causing children to enter puberty too soon, resulting in faster than normal bone growth and development of sexual characteristics). Triptorelin injection is in a class of medications called gonadotropin-releasing hormone (GnRH) agonists. It works by decreasing the amount of certain hormones in the body.

Read the full MedlinePlus article ↗

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.

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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $21,748.13 —
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J3316 $3,819.934 / J3316 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)24338-150-20
11-digit billing NDC24338-0150-20
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ3316
DescriptorINJECTION, TRIPTORELIN, EXTENDED-RELEASE, 3.75 MG
Billing units / pkg6 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
24338-0150-20 You're viewing this Main listing 1 KIT in 1 CARTON * 2 mL in 1 VIAL * 2 mL in 1 SYRINGE, GLASS 2017-09-08 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Triptodurthis 24338-0150-20 Azurity 1 kit — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2017
First FDA approval
Jun 2017
📍
2026
Currently FDA-listed
9 years listed
🛡️
2029
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jun 2029. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jun 29, 2017 RLD RS ⏳ ~2.7 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 10166181 — drug product
2017 2019 2021 2023 2025 2027 2029
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 (1)
PatentTypeUse codeExpires
US 10166181 ↗ Drug product — Jun 30, 2029
Common questions
Is there a generic version of TRIPTODUR 22.5 MG KIT?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for TRIPTODUR 22.5 MG KIT. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jun 2029 — an estimate, not a guaranteed launch date.
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.

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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
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.

Manufacturer & labeler

LabelerAzurity Pharmaceuticals, Inc.
Application holderAZURITY PHARMACEUTICALS INC
FDA applicationNDA208956 (NDA)
Labeler code24338
First marketedSep 2017
Product typeHuman Prescription Drug
Portfolio57 products on file

More NDCs from Azurity Pharmaceuticals, Inc. labeler code 24338

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.

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 🔄 Drug / Laboratory Test Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🎯 Indications and Usage 50 words ▾

1 INDICATIONS AND USAGE TRIPTODUR is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP). TRIPTODUR is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients 2 years and older with central precocious puberty. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Must only be administered by a healthcare provider. ( 2.1 ) Administer TRIPTODUR as a single intramuscular injection of 22.5 mg once every 24 weeks. ( 2.1 ) Monitor response with LH levels after a GnRH or GnRH agonist stimulation test, basal LH, or serum concentration of sex steroid levels beginning 1 to 2 months following initiation of therapy, during therapy as necessary to confirm maintenance of efficacy, and with each subsequent dose.

( 2.2 ) Measure height every 3-6 months and monitor bone age periodically. ( 2.2 ) See FPI for complete reconstitution and administration instructions. ( 2.3 ) Once TRIPTODUR is mixed, proceed to the next steps and administer without delay.

( 2.3 ) The injection of the suspension should be performed rapidly and in a steady and uninterrupted manner in order to avoid any potential blockage of the needle. ( 2.3 )

2.1Dosing Information TRIPTODUR must only be administered by a healthcare provider. The dosage of TRIPTODUR is 22.5 mg reconstituted with accompanying diluent (Sterile Water) 2 mL, and administered as a single intramuscular injection once every 24 weeks. TRIPTODUR treatment should be discontinued at the appropriate age of onset of puberty at the discretion of the physician.

2.2Monitoring Monitor response to TRIPTODUR with LH levels after a GnRH or GnRH agonist stimulation test, basal LH, or serum concentration of sex steroid levels beginning 1 to 2 months following initiation of therapy, during therapy as necessary to confirm maintenance of efficacy, and with each subsequent dose. Measure height (for calculation of growth rate) every 3-6 months and monitor bone age periodically. Noncompliance with drug regimen or inadequate dosing may result in inadequate control of the pubertal process with gonadotropins and/or sex steroids increasing above prepubertal levels.

If the dose of TRIPTODUR is not adequate switching to an alternative GnRH agonist for the treatment of CPP with the ability for dose adjustment may be necessary.

2.3Reconstitution and Administration Instructions Read these instructions completely before you begin. • Triptodur suspension will sediment very quickly and should be injected immediately after reconstitution in accordance with the detailed instructions below. • If the sequence of steps to prepare the suspension is interrupted and/or the vial is put aside, the suspension will start to separate into diluent and microgranules. • To minimize the risk of needle blockage during the injection, ensure that the preparation of the injection is not interrupted and/or the mixed suspension syringe is not put aside because the suspension will sediment quickly.

1. Use appropriate aseptic technique for preparation and administration. 2.

Screw the plunger rod into the barrel end of the prefilled sterile water diluent syringe. 3. To remove the cap, twist counterclockwise to separate from the Luer lock on the syringe barrel.

4. Firmly attach one of the 21-gauge sterile safety needles onto the prefilled sterile water diluent syringe with a push and clockwise twist. This 21-gauge needle will only be used for reconstitution of the product. a.

Remove the plastic Flip-off from the vial. Disinfect the visible part of the stopper b. Pull back on the safety cover towards the syringe and away from the 21-gauge needle.

Then pull the clear needle shield off. 5. Insert the 21-gauge needle through the stopper.

Inject the Sterile Water diluent into the vial, ensuring the diluent rinses the sides of the vial. Do not release the plunger rod. 6.

If the syringe plunger is not maintained in position, it will naturally withdraw product into the syringe. Thoroughly mix the vial with agitation for 30 to 60 seconds, ensuring the diluent rinses the sides of the vial. 7.

Before moving on to the next step, check visually that the suspension appears milky and homogeneous without any visible aggregates or precipitates. a. If the suspension DOES NOT appear milky and homogeneous without…

💊 Dosage Forms and Strengths 67 words ▾

3 DOSAGE FORMS AND STRENGTHS For extended-release injectable suspension: 22.5 mg of triptorelin as a lyophilized white to slightly yellow powder cake in a single-dose vial for reconstitution with the co-packaged 2 mL of diluent (Sterile Water) for Injection. For extended-release injectable suspension: 22.5 mg of triptorelin as a powder cake for reconstitution with the co-packaged 2 mL of diluent Sterile Water for Injection. ( 3 )

⛔ Contraindications 57 words ▾

4 CONTRAINDICATIONS Hypersensitivity: TRIPTODUR is contraindicated in individuals with a known hypersensitivity to triptorelin, any other component of the product, or other GnRH agonists or GnRH [see Adverse Reactions (6.2) ] . Pregnancy: TRIPTODUR may cause fetal harm [see Use in Specific Populations (8.1) ] . Hypersensitivity reactions ( 4 ) Pregnancy ( 4 , 8.1 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Initial Rise of Gonadotropins and Sex Steroid Levels: An increase in clinical signs and symptoms of puberty may be observed during the first 2-4 weeks of therapy since gonadotropins and sex steroids rise above baseline because of the initial stimulatory effect of the drug. ( 5.1 ) Psychiatric events: Have been reported in patients taking GnRH agonists. Events include emotional lability, such as crying, irritability, impatience, anger, and aggression.

Monitor for development or worsening of psychiatric symptoms. ( 5.2 ) Convulsions: Have been observed in patients with or without a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and in patients on concomitant medications that have been associated with convulsions. ( 5.3 ) Severe Cutaneous Adverse Reactions (SCARs): Have been reported in patients receiving GnRH agonists, including triptorelin products.

Interrupt TRIPTODUR if signs or symptoms of SCARs develop. Permanently discontinue TRIPTODUR if a SCAR is confirmed. ( 5.4 ) Pseudotumor Cerebri (Idiopathic Intracranial Hypertension): Have been reported in pediatric patients receiving GnRH agonists, including triptorelin.

Monitor patients for headache, papilledema, and blurred vision. ( 5.5 )

5.1Initial Rise of Gonadotropins and Sex Steroid Levels During the early phase of initial therapy or after subsequent doses, gonadotropins and sex steroids may rise above baseline because of a transient stimulatory effect of the drug [see Clinical Pharmacology (12.2) ] . Therefore, a transient increase in clinical signs and symptoms of puberty, including vaginal bleeding, may be observed during the first weeks of therapy or after subsequent doses.

5.2Psychiatric Events Psychiatric events have been reported in patients taking GnRH agonists, including triptorelin. Post-marketing reports with this class of drugs include symptoms of emotional lability, such as crying, irritability, impatience, anger, and aggression. Monitor for development or worsening of psychiatric symptoms during treatment with TRIPTODUR [see Adverse Reactions (6) ] .

5.3Convulsions Post-marketing reports of convulsions have been observed in patients receiving GnRH agonists, including triptorelin. These included patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and patients on concomitant medications that have been associated with convulsions such as bupropion and SSRIs. Convulsions have also been reported in patients in the absence of any of the conditions mentioned above [ see Adverse Reactions (6) ].

5.4Severe Cutaneous Adverse Reactions (SCARs) Severe cutaneous adverse reactions (SCARs) have been reported in patients receiving GnRH agonists, including triptorelin products [see Adverse Reactions ( 6.2 )] . These reactions include Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), including cases with visceral involvement and/or requiring skin grafts. Monitor patients for signs and symptoms of SCARs such as fever, flu-like symptoms, mucosal lesions, progressive skin rash or lymphadenopathy.

Advise patients and caregivers of the signs and symptoms of SCARs. If a SCAR is suspected, interrupt TRIPTODUR. Consult a healthcare provider with expertise in the diagnosis and management of SCARS.

If a diagnosis is confirmed permanently discontinue TRIPTODUR.

5.5Pseudotumor Cerebri (Idiopathic Intracranial Hypertension) Pseudotumor cerebri (idiopathic intracranial hypertension) has been reported in pediatric patients receiving GnRH agonists, including triptorelin. Monitor patients for signs and symptoms of pseudotumor cerebri, including headache, papilledema, blurred vision, diplopia, loss of vision, pain behind the eye or pain with eye movement, tinnitus, dizziness, and nausea.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described here and elsewhere in the label: Initial Rise of Gonadotropins and Sex Steroid Levels [ see Warnings and Precautions ( 5.1 ) ] Psychiatric Events [ see Warnings and Precautions ( 5.2 ) ] Convulsions [ see Warnings and Precautions ( 5.3 ) ] Severe Cutaneous Adverse Reactions [ see Warnings and Precautions ( 5.4 ) ] Pseudotumor Cerebri (Idiopathic Intracranial Hypertension) [ see Warnings and Precautions ( 5.5 ) ] In clinical trials for TRIPTODUR, the most common adverse reactions (≥4.5%) are injection site reactions, menstrual (vaginal) bleeding, hot flush, headache, cough, and infections (bronchitis, gastroenteritis, influenza, nasopharyngitis, otitis externa, pharyngitis, sinusitis, and upper respiratory tract infection).

( 6.1 ) 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 Trials 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 TRIPTODUR was evaluated in one uncontrolled, open-label single-arm clinical trial in which 44 children with central precocious puberty received two doses of TRIPTODUR and were observed for 12 months. The median age of the study population was 8 years (range 2-9 years) at treatment start; 88.6% of subjects were female, 59.1% were White, 27.3% were Black and 4.5% were Asian.

Table 1 shows all the adverse reactions that occurred in at least 2 patients (≥4.5%) during the open-label single-arm trial. Table 1: Adverse Reactions1 Occurring in ≥ 2 Patients Treated with TRIPTODUR in an Open-Label Single-Arm Trial Adverse Reactions Number of Patients Reporting Event (%) (Total N=44) Infections & Infestations Bronchitis 2 (4.5) Gastroenteritis 3 (6.8) Influenza 2 (4.5) Nasopharyngitis 6 (13.6) Otitis externa 2 (4.5) Pharyngitis 2 (4.5) Sinusitis 2 (4.5) Upper respiratory tract infection 4 (9.1) Nervous System Disorders Headache 6 (13.6) Reproductive System & Breast Disorders Menstrual (Vaginal bleeding) 2 3 (7.7) Respiratory, Thoracic & Mediastinal Disorder Cough 3 (6.8) Vascular Disorders Hot flush 2 (4.5) 1 Injection site reactions are presented separately 2 Includes % of patients with vaginal bleeding or menstrual disorder (“menstrual cycle returned”) in 39 females out of N=44.

Other Selected Adverse Reactions: Injection Site Reactions Injection site reactions occurring in patients immediately and/or 2 hours after injection include pain (45%), redness (14%), pruritus (2.3%) and swelling (2.3%). Psychiatric Disorders Anxiety (2.3%) and mood altered (2.3%)

6.2Post-marketing Experience The following adverse reactions have been identified during post-approval use of triptorelin or GnRH agonists. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Hypersensitivity Reactions: Anaphylactic shock, anaphylactoid reaction, angioedema, urticaria.

Cardiovascular: Hypertension. Psychiatric: Emotional lability, such as crying, irritability, impatience, anger, and aggression . Depression, including rare reports of suicidal ideation and attempt.

Many, but not all, of these patients had a history of psychiatric illness or other comorbidities with an increased risk of depression. Nervous System: Convulsions , pseudotumor cerebri (idiopathic intracranial hypertension) Vision Disorders: Visual impairment, visual disturbance Skin Reactions: erythema multiforme, bullous dermatitis, dermatitis exfoliative, drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome and toxic epidermal necrolysis, and acute generalized exanthematous pustulosis

🔄 Drug Interactions 108 words ▾

7 DRUG INTERACTIONS

7.1Drug-Drug Interactions Results of in vitro studies show that drug-drug interactions with triptorelin are unlikely [see Clinical Pharmacology (12.3)] . However, in the absence of relevant data and as a precaution, hyperprolactinemic drugs should not be used concomitantly with triptorelin since hyperprolactinemia reduces the number of pituitary GnRH receptors.

7.2Drug-Laboratory Test Interactions Administration of TRIPTODUR results in suppression of the pituitary-gonadal system. The effect of TRIPTODUR on pituitary and gonadal function is expected to disappear within six to twelve months after treatment discontinuation. Therefore, diagnostic tests of pituitary gonadotropic and gonadal functions conducted during treatment or after discontinuation of treatment may be affected.

🔄 Drug / Laboratory Test Interactions 55 words ▾

7.2Drug-Laboratory Test Interactions Administration of TRIPTODUR results in suppression of the pituitary-gonadal system. The effect of TRIPTODUR on pituitary and gonadal function is expected to disappear within six to twelve months after treatment discontinuation. Therefore, diagnostic tests of pituitary gonadotropic and gonadal functions conducted during treatment or after discontinuation of treatment may be affected.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary TRIPTODUR is contraindicated in women who are pregnant [ see Contraindications ( 4 ) ] since expected hormonal changes that occur with TRIPTODUR treatment increase the risk for pregnancy loss. Available data with triptorelin use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes. Based on mechanism of action in humans and findings of increased pregnancy loss in animal studies, TRIPTODUR may cause fetal harm when administered to pregnant women.

Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% - 4% and 15% -20%, respectively.

Data Animal Data In pregnant rats administered triptorelin at doses of 2, 10, and 100 mcg/kg/day during the period of organogenesis, maternal toxicity (decrease in body weight) and embryo-fetal toxicities (pre-implantation loss, increased resorption, and reduced number of viable fetuses) were observed at 100 mcg/kg, approximately 4 times the clinical dose based on body surface area. No embryonic and fetal developmental toxicities were observed in mice at doses up to 4 times the clinical dose. Teratogenic effects were not observed in viable fetuses in rats or mice.

8.2Lactation Risk Summary There are no data on the presence of triptorelin in human milk, or the effects of the drug on the breastfed infant, or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TRIPTODUR and any potential adverse effects on the breastfed child from TRIPTODUR or from the underlying maternal condition

8.6Renal Impairment TRIPTODUR has not been studied in children with renal impairment. Adult subjects with renal impairment had higher exposure than young healthy adult males [see Clinical Pharmacology (12.3) ].

8.4Pediatric Use The safety and effectiveness of TRIPTODUR have been established in pediatric patients 2 years of age and older based on a single-arm open-label study of 44 children 2-9 years of age with CPP [see Clinical Studies (14) ] . The safety and effectiveness of TRIPTODUR have not been established in pediatric patients less than 2 years old.

8.7Hepatic Impairment TRIPTODUR has not been studied in children with hepatic impairment. Adult subjects with hepatic impairment had higher exposure than young healthy adult males [see Clinical Pharmacology (12.3) ].

🤰 Pregnancy 219 words ▾

8.1Pregnancy Risk Summary TRIPTODUR is contraindicated in women who are pregnant [ see Contraindications ( 4 ) ] since expected hormonal changes that occur with TRIPTODUR treatment increase the risk for pregnancy loss. Available data with triptorelin use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes. Based on mechanism of action in humans and findings of increased pregnancy loss in animal studies, TRIPTODUR may cause fetal harm when administered to pregnant women.

Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% - 4% and 15% -20%, respectively.

Data Animal Data In pregnant rats administered triptorelin at doses of 2, 10, and 100 mcg/kg/day during the period of organogenesis, maternal toxicity (decrease in body weight) and embryo-fetal toxicities (pre-implantation loss, increased resorption, and reduced number of viable fetuses) were observed at 100 mcg/kg, approximately 4 times the clinical dose based on body surface area. No embryonic and fetal developmental toxicities were observed in mice at doses up to 4 times the clinical dose. Teratogenic effects were not observed in viable fetuses in rats or mice.

🧒 Pediatric Use 60 words ▾

8.4Pediatric Use The safety and effectiveness of TRIPTODUR have been established in pediatric patients 2 years of age and older based on a single-arm open-label study of 44 children 2-9 years of age with CPP [see Clinical Studies (14) ] . The safety and effectiveness of TRIPTODUR have not been established in pediatric patients less than 2 years old.

🆘 Overdosage 27 words ▾

10 OVERDOSAGE There is no experience with overdosage in clinical trials of triptorelin. If overdosage occurs, therapy should be discontinued and appropriate supportive and symptomatic treatment administered.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Triptorelin is a GnRH agonist.

12.2Pharmacodynamics Following the first administration, there is a transient surge in circulating levels of LH, FSH, testosterone, and estradiol [see Warnings and Precautions (5.2) ] . After chronic and continuous administration, by 4 weeks after initiation of therapy, a sustained decrease in LH and FSH secretion and marked reduction in sex steroids are observed.

12.3Pharmacokinetics Absorption After an initial intramuscular TRIPTODUR 22.5 mg injection and a second 22.5 mg intramuscular injection 24 weeks later in children 2 to 9 years old with CPP, triptorelin peaked 4 hours postdose with a geometric mean C max of 39.9 and 36.5 ng/mL, respectively. No apparent accumulation of triptorelin occurred after the second injection. Absorption occurred in two phases, a burst phase followed by a maintenance release phase.

In children with CPP, following the burst phase after the first 22.5 mg injection, geometric mean serum triptorelin levels were 0.11, 0.17, 0.05 and 0.03 ng/mL at Months 1, 2, 3, and 6, respectively. Distribution There is no evidence that triptorelin, at clinically relevant concentrations, binds to plasma proteins. Elimination Metabolism The metabolism of triptorelin in humans is unknown, but is unlikely to involve hepatic microsomal enzymes (cytochrome P450).

Thus far no metabolites of triptorelin have been identified. Pharmacokinetic data suggest that C-terminal fragments produced by tissue degradation are either completely degraded in the tissues, or rapidly degraded in plasma, or cleared by the kidneys. Excretion Triptorelin is eliminated by both the liver and the kidneys.

Following intravenous administration of 0.5 mg triptorelin peptide to six healthy male volunteers with a creatinine clearance of 149.9 mL/min, 41.7% of the dose was excreted in urine as intact peptide with a total triptorelin clearance of 211.9 mL/min. This percentage increased to 62.3% in patients with liver disease who have a lower creatinine clearance (89.9 mL/min). It has also been observed that the nonrenal clearance of triptorelin (patient anuric, Cl creat = 0) was 76.2 mL/min, thus indicating that the nonrenal elimination of triptorelin is mainly dependent on the liver.

Specific Populations Renal Impairment After intravenous bolus injection of 0.5 mg triptorelin in adults, the two distribution half-lives were unaffected by renal impairment. However, renal insufficiency led to a decrease in total triptorelin clearance proportional to the decrease in creatinine clearance as well as increases in volume of distribution and consequently, an increase in the elimination half-life. Adult male subjects with moderate or severe renal impairment had approximately 2-fold higher exposure (AUC values) than young healthy adult males (see Table 1) [ see Use in Specific Populations ( 8.6 ) ].

Hepatic Impairment After intravenous bolus injection of 0.5 mg triptorelin in adults, the two distribution half-lives were unaffected by hepatic impairment. In adult males with hepatic insufficiency, triptorelin clearance was reduced and exposure (AUC) was increased 3.7-fold compared to young healthy adult males (Table 2) [ see Use in Specific Populations ( 8.7 ) ]. Table 2: Pharmacokinetic Parameters (Mean ± SD) in Healthy Adults, Adults with Renal Impairment, and Adults with Hepatic Impairment Following an I.V.

Bolus of 0.5 mg Triptorelin in Solution Group C max (ng/mL) AUC inf (h·ng/mL) Cl p (mL/min) Cl renal (mL/min) t 1/2 (h) Cl creat (mL/min) 6 healthy male volunteers 48.2 ±11.8 36.1 ±5.8 211.9 ±31.6 90.6 ±35.3 2.81 ±1.21 149.9 ±7.3 6 males with moderate renal impairment 45.6 ±20.5 69.9 ±24.6 120.0 ±45.0 23.3 ±17.6 6.56 ±1.25 39.7 ±22.5 6 males with severe renal impairment 46.5 ±14.0 88.0 ±18.4 88.6 ±19.7 4.3 ±2.9 7.65 ±1.25 8.9 ±6.0 6 males with liver disease 54.1 ±5.3 131.9 ±18.1 57.8 ±8.0 35.9 ±5.0 7.58 ±1.17 89.9 ±15.1 Drug-Drug Interactions In Vitro Assessment of Drug Intera…

🧬 Mechanism of Action 9 words ▾

12.1Mechanism of Action Triptorelin is a GnRH agonist.

📦 How Supplied / Storage and Handling 94 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Each TRIPTODUR 22.5 mg single-use kit (NDC 24338-150-20) contains: One single-dose vial of TRIPTODUR 22.5 mg (NDC 24338-150-01) with a Flip-Off seal containing sterile lyophilized white to slightly yellow powder cake One sterile, glass syringe with Luer Lock prefilled with 2 mL of Sterile Water for Injection (NDC 24338-150-02) Two sterile 21 gauge, 1½" needles ( thin-wall ) with safety cover One Package Insert Store at 20 to 25°C (68 to 77°F) excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Do not freeze.

📋 Description 141 words ▾

11 DESCRIPTION TRIPTODUR contains the pamoate salt of triptorelin, a synthetic decapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LHRH). The chemical name of triptorelin pamoate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-tryptophyl-L-leucyl-L-arginyl-L-prolylglycine amide (pamoate salt). The molecular weight is 1699.9 and the structural formula is: TRIPTODUR for extended release injectable suspension for intramuscular use is provided as a sterile, lyophilized, biodegradable microgranule formulation in a single-dose vial, co-packaged with a syringe containing 2 mL Sterile Water for Injection for reconstitution of the lyophilisate.

The triptorelin formulation is comprised of 22.5 mg triptorelin (equivalent to 31 mg triptorelin pamoate), carboxymethylcellulose sodium (26 mg), mannitol (74 mg), poly- d,l- lactide-co-glycolide (183 mg), and polysorbate 80 (1.7 mg). When 2 mL Sterile Water for Injection is added to the vial containing TRIPTODUR and mixed, a suspension is formed which is intended as a single intramuscular injection. triptodur-spl-11

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Medication Guide). Hypersensitivity Reactions Inform caregivers that anaphylactic shock, hypersensitivity, and angioedema have been reported with triptorelin use and to immediately seek medical attention if any hypersensitivity reaction occurs. Symptoms after Initial TRIPTODUR Administratio n Inform caregivers that during the first weeks after the first TRIPTODUR injection, signs of puberty may occur such as vaginal bleeding [ see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 ) ].

Caregivers should notify the physician if these symptoms continue beyond the second month after TRIPTODUR administration. Psychiatric Events Inform caregivers that symptoms of emotional lability, such as crying, irritability, impatience, anger, and aggression have been observed in patients receiving GnRH agonists, including triptorelin. Alert caregivers to the possibility of development or worsening of psychiatric symptoms, including depression, during treatment with TRIPTODUR [ see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.2 ) ].

Convulsions Inform caregivers that reports of convulsions have been observed in patients receiving GnRH agonists, including triptorelin. Patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and patients on concomitant medications that have been associated with convulsions may be at increased risk [ see Warnings and Precautions ( 5.3 ) ]. Severe Cutaneous Adverse Reactions Inform patients and/or caregivers that severe cutaneous adverse reactions (SCARs) may occur during treatment with TRIPTODUR.

Advise patients and/or caregivers to stop TRIPTODUR and immediately contact their healthcare provider if they experience signs or symptoms of SCARs [ see Warnings and Precautions ( 5.4 ) ]. Pseudotumor Cerebri (Idiopathic Intracranial Hypertension) Inform patients and caregivers that reports of pseudotumor cerebri (idiopathic intracranial hypertension) have been observed in pediatric patients receiving GnRH agonists, including triptorelin. Monitor patients for signs and symptoms of pseudotumor cerebri, including headache, and vision issues such as blurred vision, double vision, loss of vision, pain behind the eye or pain with eye movement, ringing in the ears, dizziness, and nausea.

Advise patients and caregivers to contact their healthcare provider if the patient develops any of these symptoms. [ see Warnings and Precautions ( 5.5 ) ]. Pregnancy is Contraindicated TRIPTODUR is contraindicated in pregnancy. If the patient becomes pregnant while taking the drug, the patient should be informed of the potential risk to fetus [ see Use in Specific Populations ( 8.1 ) ].

Compliance with the Dosing Schedule Inform caregivers about the importance of adherence to the TRIPTODUR dosing schedule of one injection every 24 weeks. Patients should not miss or delay a scheduled dose. Manufactured for: Azurity Pharmaceuticals, Inc.

Woburn, MA 01801 Manufactured by: Debiopharm Research & Manufacturing SA CH-1920 Martigny, Switzerland TRIPTODUR is a registered trademark of Debiopharm International SA. Patent: https://azurity.com/patents_and_trademarks/ This product's labeling may have been updated. For current Full Prescribing Information, please visit www.triptodur.com TRIP-PI-09 Rev.

09/2025

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE TRIPTODUR® [TRIP-toe-der] (triptorelin) for extended-release injectable suspension, for intramuscular use What is the most important information I should know about TRIPTODUR? In the first few weeks after your child receives their first TRIPTODUR injection or after additional injections, TRIPTODUR can cause a brief increase in some hormones. During this time you may notice more signs of puberty in your child, including vaginal bleeding.

Call your child’s doctor if signs of puberty continue after 2 months of receiving TRIPTODUR. Some people taking gonadotropin releasing hormone (GnRH) agonists like TRIPTODUR have had new or worsened mental (psychiatric) problems. Mental (psychiatric) problems may include emotional symptoms such as: crying irritability restlessness (impatience) anger acting aggressive Call your child’s doctor right away if your child has any new or worsening emotional symptoms while taking TRIPTODUR.

Some people taking GnRH agonists like TRIPTODUR have had seizures. The risk of seizures may be higher in people who: have a history of seizures have a history of epilepsy have a history of brain or brain vessel (cerebrovascular) problems or tumors are taking a medicine that has been connected with seizures such as bupropion or selective serotonin reuptake inhibitors (SSRIs) Seizures have also happened in people who have not had any of these problems. Call your child’s doctor right away if your child has a seizure while taking TRIPTODUR.

Severe cutaneous (skin) adverse reactions can happen during treatment with GnRH agonists like TRIPTODUR. Stop TRIPTODUR and call your child’s doctor right away if your child has any of the following signs or symptoms during treatment with TRIPTODUR: skin rash or acnedry skin itching blisters on your skin redness or swelling of your face, hands, or soles of your feet blisters or sores in your mouth peeling of your skin fever muscle or joint aches swollen glands Increased pressure in the fluid around the brain can happen in children taking GnRH agonists medicines including TRIPTODUR.

Call your child’s doctor right away if your child has any of the following symptoms during treatment with TRIPTODUR: headache ringing in the ears eye problems, including blurred vision, double vision and decreased eyesight dizziness nausea eye pain What is TRIPTODUR? TRIPTODUR is an injectable prescription GnRH medicine used for the treatment of children with central precocious puberty (CPP). It is not known if TRIPTODUR is safe and effective in children under 2 years of age.

TRIPTODUR should not be taken if your child is: allergic to gonadotropin releasing hormone (GnRH), GnRH agonist medicines, or any ingredients in TRIPTODUR. See the end of this Medication Guide for a complete list of ingredients in TRIPTODUR. Some people taking triptorelin, the active ingredient in TRIPTODUR, have had serious allergic reactions.

Call your child’s doctor or get emergency medical help right away if your child gets any of the following symptoms of a serious allergic reaction: skin rashes, redness, or swelling severe itching hives trouble breathing or swallowing fast heart beat sweating throat tightness, hoarseness swelling of face, mouth, and tongue dizziness or fainting pregnant or becomes pregnant. TRIPTODUR can cause birth defects or loss of the baby. If your child becomes pregnant call your doctor.

Before your child receives TRIPTODUR, tell your child’s doctor about all of your child’s medical conditions, including if they: have a history of mental (psychiatric) problems. have a history of seizures. have a history of epilepsy. have a history of brain or brain vessel (cerebrovascular) problems or tumors. are breastfeeding or plan to breastfeed. It is not known if TRIPTODUR passes into breastmilk. Tell the doctor about all the medicines your child takes , including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will your child receive TRIPTODUR? Your child’s doctor sh…

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
940
Units reimbursed last 4 qtrs
928
Gross reimbursed last 4 qtrs
$20.18M
Avg / prescription
$21,470.50
Avg / unit
$21,740.33
Latest quarter Q1 2026
178Rx
Fee-for-service vs managed care ⓘ
27% FFS 73% MCO
Fee-for-service · 253 Rx Managed care · 687 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 101 units · 0.5 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 52 units · 0.4 per 100k residents IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 111 units · 0.9 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 26 units · 0.1 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: 73 units · 4.1 per 100k residents WV Virginia: no data reported VA Maryland: 28 units · 0.5 per 100k residents MD Connecticut: 29 units · 0.8 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 134 units · 1.2 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 49 units · 1.2 per 100k residents OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: 13 units · 0.3 per 100k residents AL Georgia: 85 units · 0.8 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 60 units · 0.2 per 100k residents TX Florida: 167 units · 0.7 per 100k residents FL
Units reimbursed · per 100k residents
0.14.1
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 West Virginia 4.1 /100k
2 North Carolina 1.2 /100k
3 Oklahoma 1.2 /100k
4 Pennsylvania 0.9 /100k
5 Connecticut 0.8 /100k
6 Georgia 0.8 /100k
7 Florida 0.7 /100k
8 New York 0.5 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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) ✓ Available
“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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 J3316 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.
← 24338-0136-10 · Azurity 24338-0153-02 · 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.