Home › NDC Lookup › Ingredients › Triamcinolone Acetonide › 24208-0040-40
Xipere triamcinolone acetonide 40 mg/mL Injection, Suspension, 1 vial — NDC 24208-0040-40 package photo

Xipere triamcinolone acetonide 40 mg/mL Injection, Suspension, 1 vial

by Bausch & Lomb Incorporated · 1 TRAY in 1 CARTON (24208-040-40) / 1 VIAL in 1 TRAY / .9 mL in 1 VIAL (24208-040-41)
NDC 24208-0040-40
🏷️ FDA NDC (as labeled) 24208-040-40 billing pads the product segment with a zero
This package
Contains1 vial Medicaid pays$1,598.70 / unit · 12 mo Per package$1,438.83 / 0.9 ml · Medicaid Pack sizes2 compare ↓
Also comes in: 1 vial 24208-0040-01
Rx only Brand On market Non-controlled
🗂️ 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 Triamcinolone Acetonide (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 · Sep 28, 2023 — Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial. (Eugia US LLC) · FDA recall D-0041-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 24208-040-40
Product NDC 24208-040
11-digit billing NDC 24208004040
NCPDP billing unit ML — per mL (volume)
RxCUI 2585221, 2585226
UNII F446C597KA
Application # NDA211950
SPL Set ID ea6ad429-967f-4f75-a33d-e06f849bee80
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-12-17
Route OPHTHALMIC
Dosage form INJECTION, SUSPENSION
Substance TRIAMCINOLONE ACETONIDE
GPI-14 86300080101830
GCN Seq No 083416
GCN 52373
HICL code 035556
Ingredient (HICL) Triamcinolone Acetonide/Pf
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6P
Therapeutic class — specific (HIC3) Eye Anti-Inflammatory Agents
AHFS code 52:08.08.00
AHFS class Corticosteroids (Eent)
FDB label name XIPERE 40 MG/ML VIAL
FDB brand name Xipere
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 24208-040-40 — 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 → 24208-0040-40. 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 Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids for local oral treatment, Corticosteroids, Corticosteroids, moderately potent (group II)
How it works Corticosteroid 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.

🏭 Manufacturer & labeler

LabelerBausch & Lomb Incorporated
Application holderBAUSCH AND LOMB INC
FDA applicationNDA211950 (NDA)
Labeler code24208
First marketedDec 2021
Product typeHuman Prescription Drug
Portfolio92 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 XIPERE 40 MG/ML VIAL Ingredient Triamcinolone Acetonide/Pf
📖 What it is MedlinePlus · NLM

Triamcinolone, a corticosteroid, is similar to a natural hormone produced by your adrenal glands. It often is used to replace this chemical when your body does not make enough of it. It relieves inflammation (swelling, heat, redness, and pain) and is used to treat certain forms of arthritis; skin, blood, kidney, eye, thyroid, and intestinal disorders (e.g., colitis); severe allergies; and asthma. Triamcinolone is also used to treat certain types of cancer. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Yes, intra-articular triamcinolone is specifically approved to give short-term relief for knee arthritis, gout flares, bursitis, and similar joint conditions. The extended-release...
  • I'm getting a triamcinolone injection in my knee. Will it actually help, and how long does it last?
  • That's a really important thing to flag with your doctor before your injection or prescription. Triamcinolone can raise blood sugar — even in people whose diabetes is well-controll...
  • I have diabetes. Should I be worried about using triamcinolone?
📖 Read our full Triamcinolone guide →
8
Nutrient depletion considerations

Triamcinolone Acetonide may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Triamcinolone Acetonide nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.

💊 What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

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

  • UNII M4I0D6VV5M
    Calcium chloride is a salt compound that acts as a firming agent and source of calcium ions in medications. It's used in formulations to help maintain tablet structure, improve texture, or serve as a buffering agent.
  • UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 02F3473H9O
    A mineral salt used in medications as a source of magnesium. It helps bind ingredients together, improve texture, and maintain the product's stability during storage.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 660YQ98I10
    Potassium chloride is a mineral salt used in medicines as a buffer and to help maintain the proper pH balance and stability of the formulation during storage and use.
  • UNII 4550K0SC9B
    Sodium acetate is a salt derived from acetic acid. It acts as a buffer to help maintain the medicine's pH stability and may serve as a preservative or solubilizer in liquid formulations.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII B22547B95K
    A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

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

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $1,598.70 $1,438.83 / 0.9 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J3299 $47.770 / J3299 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)24208-040-40
11-digit billing NDC24208-0040-40
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ3299
DescriptorInjection, triamcinolone acetonide (xipere), 1 mg
Billing units / pkg36 units
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Xipere 40 mg/mLthis 24208-0040-40 Bausch 1 vial — — FDA listed —
Triesence 40 mg/mL 00078-0897-78 Novartis 1 vial — — FDA listed —
Triesence 40 mg/mL 82667-0800-01 Harrow 1 vial — — 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

🏛️
2021
First FDA approval
Oct 2021
📍
2026
Currently FDA-listed
5 years listed
🛡️
2040
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 Apr 2040. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Oct 22, 2021 RLD RS ⏳ ~13.6 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 12419833 — method of use (U-3234)
US 8636713 — method of use (U-3234)
US 9636332 — method of use (U-3234)
US 9937075 — drug product
2021 2023 2025 2027 2029 2031 2033 2035 2037 2039
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 (4)
PatentTypeUse codeExpires
US 12419833 ↗ Method of use U-3234 Apr 16, 2040
US 8636713 ↗ Method of use U-3234 May 2, 2027
US 9636332 ↗ Method of use U-3234 Nov 8, 2033
US 9937075 ↗ Drug product — May 2, 2034
Common questions
Is there a generic version of XIPERE 40 MG/ML VIAL?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for XIPERE 40 MG/ML VIAL. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Apr 2040 — 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.

🗺️ 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 24208-0040-40, 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 – Q4 2025 · 4 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
53
Units reimbursed last 4 qtrs
26
Gross reimbursed last 4 qtrs
$41.6K
Avg / prescription
$784.27
Avg / unit
$1,584.99
Latest quarter Q4 2025
11Rx
Fee-for-service vs managed care ⓘ
49% FFS 51% MCO
Fee-for-service · 26 Rx Managed care · 27 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: no data reported 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: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 14 units · 0.1 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: 5 units · 0.1 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: 7 units · 0.2 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: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.10.2
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 Connecticut 0.2 /100k
2 Pennsylvania 0.1 /100k
3 Colorado 0.1 /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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 vial this page24208-0040-40 53 Rx · $41,566
1 vial24208-0040-01 No Medicaid data
Drug total (last 4 qtrs): 53 Rx · 26 units · $41,566 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)

Medicare Part D (outpatient prescription) spending for Xipere — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Xipere. 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.
Total Part D spend
$37.6K
Claims incl. refills
20
Beneficiaries
12
Spend / beneficiary
$3,133.97
Spend / claim
$1,880.38
💵 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 Xipere (this brand).

Top reported reactions

Pruritus2,512
Rash2,412
Pain2,037
Fatigue1,938
Nausea1,851
Vomiting1,626
Diarrhoea1,603

Age at onset

Neonate11
Infant49
Child598
Adolescent456
Adult4,960
Elderly2,219

Reporter sex

23,307 reports
Male · 34%
Female · 66%
Unknown · 0%

Serious outcomes

Hospitalization6,048
Death3,019
Life-threatening2,329
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3,841 1,205
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
24208-0040-01 1 TRAY in 1 CARTON (24208-040-01) / 1 VIAL in 1 TRAY / .9 mL in 1 VIAL (24208-040-02) 2021-12-17 Active
24208-0040-40 You're viewing this 1 TRAY in 1 CARTON (24208-040-40) / 1 VIAL in 1 TRAY / .9 mL in 1 VIAL (24208-040-41) 2021-12-17 Active

Pack size FAQ

What quantity is in NDC 24208-0040-40?
NDC 24208-0040-40 contains 1 vial — 1 tray in 1 carton / 1 vial in 1 tray / .9 ml in 1 vial.
What is the difference between NDC 24208-0040-40 and NDC 24208-0040-01?
Both are Xipere triamcinolone acetonide 40 mg/mL Injection, Suspension — the drug itself is identical. NDC 24208-0040-40 is the 1 vial package, while NDC 24208-0040-01 is the 1 vial package.
What NDC number is used to bill for this package of Xipere triamcinolone acetonide 40 mg/mL Injection, Suspension?
Bill NDC 24208-0040-40 — the 11-digit billing format is 24208004040. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ 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 FDA registers it as 24208-040-40, 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: 24208-0040-40, written without dashes as 24208004040. 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 24208-0040-40, the first segment (24208) is the labeler code FDA assigned to Bausch & Lomb Incorporated; the middle segment (0040) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (40) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Bausch & Lomb Incorporated. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 vial (24208-0040-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Bausch & Lomb Incorporated 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 J3299 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 41 words ▾

1 INDICATIONS AND USAGE XIPERE ® (triamcinolone acetonide injectable suspension) 40 mg/mL is indicated for the treatment of macular edema associated with uveitis. XIPERE ® is a corticosteroid indicated for the treatment of macular edema associated with uveitis. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION The recommended dosage is 4 mg (0.1 mL) administered as a suprachoroidal injection. ( 2.1 )

2.1Dosing Information For suprachoroidal injection using the SCS Microinjector ® . The recommended dose of XIPERE ® is 4 mg (0.1 mL of the 40 mg/mL injectable suspension).

2.2Preparation for Administration Suprachoroidal injection is performed under aseptic conditions. The components for administration include: One single-dose glass vial of triamcinolone acetonide injectable suspension 40 mg/mL One SCS Microinjector ® syringe with vial adapter attached One 30-G x 900-µm needle One 30-G x 1100-µm needle Step 1 Figure A Remove the tray from the carton (see Figure A). The tray consists of two compartments: An open, non-sterile compartment that holds the vial A sealed compartment that contains a sterile tray Step 2 Figure B Examine the tray for damage (see Figure B).

Ensure that the sealed compartment cover is intact and that there is no evidence of damage. If damage is present, do not use. Step 3 Figure C Remove the vial from the tray (see Figure C).

Examine the vial and ensure there is no evidence of damage. Set aside for use in Step 6. Step 4 Figure D Peel off the compartment cover, exposing the sterile tray (see Figure D).

Step 5 Figure E Grasp and hold the long sides of the tray and invert the tray. Squeeze gently to release the sterile tray onto the appropriate sterile preparation surface (see Figure E, i– iii ). Step 6 Figure F Vigorously shake the vial for 10 seconds.

Inspect the vial for clumping or granular appearance of the sterile contents. If clumping or granular appearance is present, do not use. Remove the protective plastic cap from the vial and clean the top of the vial with an alcohol wipe.

Place the vial on a flat surface (see Figure F, i – iv ). To avoid settling of the suspension, continue to the next steps without delay. Step 7 Remove the syringe with attached vial adapter from the tray (see Figure G).

Ensure the vial adapter is secured to the syringe by tightening the connection. Figure G Step 8 Holding the clear barrel of the syringe, connect the vial adapter to the vial by firmly pushing the spike of the vial adapter straight through the center of the vial septum until it snaps securely into place (see Figure H). NOTE: Do not introduce additional air into the syringe prior to connecting the vial adapter to the vial.

Figure H Step 9 Figure I Invert the entire assembly so that the vial is directly above the syringe. Slide the white plunger handle all the way back and forth multiple times to fill the entire syringe with drug and remove any remaining air (see Figure I, i and ii ). NOTE: The syringe should be handled by the clear barrel during filling, connecting and disconnecting procedures.

The white plunger handle has a stop to prevent complete removal of the plunger from the syringe. Step 10 Figure J While holding the vial adapter and vial, disconnect the syringe by twisting it off of the adapter (see Figure J). Retain the vial, with the vial adapter connected, in the event re-access is necessary.

Step 11 Figure K Connect the 900-µm needle to the syringe by twisting onto the syringe (see Figure K). At the discretion of the physician, the longer needle may be used. Ensure a secure connection.

Step 12 Figure L Hold the syringe barrel with the needle pointing up. Expel air bubbles and excess drug by slowly sliding the white plunger handle so that the plunger tip aligns with the line that marks 0.1 mL on the syringe (see Figure L). NOTE: Perform the suprachoroidal injection without delay to prevent settling of the drug.

IMAGE 1 IMAGE 2 IMAGE 3 IMAGE 4 IMAGE 5 IMAGE 6 IMAGE 7 IMAGE 8 IMAGE 9 IMAGE 10 IMAGE 11 IMAGE 12 IMAGE 13

2.3Administration The suprachoroidal injection procedure should be carried out under controlled aseptic conditions, which include the use of sterile gloves, a sterile drape, a sterile eyelid speculum (or equivalent), and a sterile cotton swab. Adequate anesthesia and a…

💊 Dosage Forms and Strengths 39 words ▾

3 DOSAGE FORMS AND STRENGTHS Injectable suspension: triamcinolone acetonide 40 mg/mL suspension in a single-dose glass vial for use with the supplied SCS Microinjector ® . Injectable suspension: triamcinolone acetonide 40 mg/mL in a single-dose vial. ( 3 )

⛔ Contraindications 85 words ▾

4 CONTRAINDICATIONS Ocular or periocular infections ( 4.1 ) Hypersensitivity to triamcinolone or any component of this product ( 4.2 )

4.1Ocular or Periocular Infections XIPERE ® is contraindicated in patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.

4.2Hypersensitivity XIPERE ® is contraindicated in patients with known hypersensitivity to triamcinolone acetonide or any other components of this product.

⚠️ Warnings and Cautions 192 words ▾

5 WARNINGS AND PRECAUTIONS Potential Corticosteroid-Related Effects : Use of corticosteroids may produce cataracts, increased intraocular pressure, and glaucoma. ( 5.1 )

5.1Potential Corticosteroid-Related Effects Use of corticosteroids may produce cataracts, increased intraocular pressure, and glaucoma. Use of corticosteroids may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses. Corticosteroids should be used cautiously in patients with a history of ocular herpes simplex. Corticosteroids should not be used in patients with active ocular herpes simplex.

5.2Alterations in Endocrine Function Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and hyperglycemia can occur following administration of a corticosteroid. Monitor patients for these conditions with chronic use. Corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment.

Drug induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients.

Changes in thyroid status of the patient may necessitate adjustment in dosage.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS In controlled studies, the most common adverse reactions reported by ≥ 10% of patients and at a rate greater than control included elevated intraocular pressure and eye pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 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. XIPERE ® was studied in a multicenter, randomized, sham-controlled, double-masked study in patients with macular edema associated with uveitis. Table 1 summarizes data available from the clinical trial for XIPERE ® treated patients and control patients.

The most common ocular (study eye) adverse reactions occurring in ≥ 2% of patients and non-ocular adverse reactions occurring in ≥ 5% of patients are shown in Table 1. Table 1: Ocular Adverse Reactions Reported in ≥ 2% of Patients and Non-ocular Adverse Reactions Reported in ≥ 5% of Patients a Includes intraocular pressure increased and ocular hypertension b Defined as not occurring on the day of the injection procedure, or occurring on the day of the injection procedure and not resolving the same day c Includes cataract, cataract cortical, and cataract subcapsular d Defined as occurring on the day of the injection procedure and resolving the same day Adverse Reaction XIPERE ® (N = 96) n (%) Control (N = 64) n (%) Ocular Increased intraocular pressure, non-acute a, b 13 (14%) 9 (14%) Eye pain, non-acute b 11 (12%) 0 Cataract c 7 (7%) 4 (6%) Increased intraocular pressure, acute a, d 6 (6%) 0 Vitreous detachment 5 (5%) 1 (2%) Injection site pain 4 (4%) 2 (3%) Conjunctival haemorrhage 4 (4%) 2 (3%) Visual acuity reduced 4 (4%) 1 (2%) Dry eye 3 (3%) 1 (2%) Eye pain, acute d 3 (3%) 0 Photophobia 3 (3%) 0 Vitreous floaters 3 (3%) 0 Uveitis 2 (2%) 7 (11%) Conjunctival hyperaemia 2 (2%) 2 (3%) Punctate keratitis 2 (2%) 1 (2%) Conjunctival oedema 2 (2%) 0 Meibomianitis 2 (2%) 0 Anterior capsule contraction 2 (2%) 0 Chalazion 2 (2%) 0 Eye irritation 2 (2%) 0 Eye pruritus 2 (2%) 0 Eyelid ptosis 2 (2%) 0 Photopsia 2 (2%) 0 Vision blurred 2 (2%) 0 Non-ocular Headache 5 (5%) 2 (3%)

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with XIPERE ® in pregnant women to inform drug-associated risks. In animal reproductive studies from the published literature, topical ocular administration of corticosteroids has been shown to produce teratogenicity at clinically relevant doses. There is negligible systemic XIPERE ® exposure following suprachoroidal injection [see Clinical Pharmacology ( 12.3 )] .

Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Animal Data Animal reproduction studies using XIPERE ® have not been conducted. In animal reproductive studies from the published literature, topical ocular administration of corticosteroids to pregnant mice and rabbits during organogenesis has been shown to produce cleft palate, embryofetal death, herniated abdominal viscera, hypoplastic kidneys, and craniofacial malformations.

8.2Lactation Risk Summary It is not known whether ocular administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for XIPERE ® and any potential adverse effects on the breastfed infant from XIPERE ® .

There are no data on the effects of XIPERE ® on milk production.

8.4Pediatric Use Safety and effectiveness of XIPERE ® in pediatric patients have not been established.

8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients following XIPERE ® administration.

🤰 Pregnancy 169 words ▾

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with XIPERE ® in pregnant women to inform drug-associated risks. In animal reproductive studies from the published literature, topical ocular administration of corticosteroids has been shown to produce teratogenicity at clinically relevant doses. There is negligible systemic XIPERE ® exposure following suprachoroidal injection [see Clinical Pharmacology ( 12.3 )] .

Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Animal Data Animal reproduction studies using XIPERE ® have not been conducted. In animal reproductive studies from the published literature, topical ocular administration of corticosteroids to pregnant mice and rabbits during organogenesis has been shown to produce cleft palate, embryofetal death, herniated abdominal viscera, hypoplastic kidneys, and craniofacial malformations.

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use Safety and effectiveness of XIPERE ® in pediatric patients have not been established.

🧓 Geriatric Use 22 words ▾

8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients following XIPERE ® administration.

🧬 Clinical Pharmacology 174 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Triamcinolone acetonide is a synthetic glucocorticoid (glucocorticoids are often referred to as corticosteroids) with immunosuppressive and anti-inflammatory activity. The primary mechanism of action for triamcinolone acetonide is as a corticosteroid hormone receptor agonist.

12.3Pharmacokinetics In animal studies, data demonstrated that suprachoroidal injections resulted in larger amounts in total of triamcinolone acetonide found in the sclera, choroid, retinal pigment epithelial and retina, than with intravitreal injections of triamcinolone acetonide. Lower amounts of triamcinolone acetonide were found in the anterior segment and lens as compared to intravitreal injections of triamcinolone acetonide. Plasma triamcinolone acetonide concentrations were evaluated in 19 patients with dosing of 4 mg XIPERE ® at Day 0 and Week 12.

Plasma triamcinolone acetonide concentrations in all 19 patients were below 100 pg/mL at Week 4, 12, and 24 (concentrations ranged from < 10 pg/mL [LLOQ (lower limit of quantitation) of the assay] to 88.9 pg/mL), with the exception of one patient with a value of 243.4 pg/mL prior to the second dose at Week 12.

🧬 Mechanism of Action 37 words ▾

12.1Mechanism of Action Triamcinolone acetonide is a synthetic glucocorticoid (glucocorticoids are often referred to as corticosteroids) with immunosuppressive and anti-inflammatory activity. The primary mechanism of action for triamcinolone acetonide is as a corticosteroid hormone receptor agonist.

📦 How Supplied / Storage and Handling 95 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING XIPERE ® is supplied with the following sterile components for administration, sealed in a Tyvek covered tray, and one single-dose glass vial, in a carton with a package insert (NDC 24208-040-40): One SCS Microinjector ® syringe with vial adapter attached One 30-G x 900-µm needle One 30-G x 1100-µm needle One single-dose vial of triamcinolone acetonide injectable suspension 40 mg/mL (NDC 24208-040-41) Storage: Store at 15°C to 25°C (59°F to 77°F); do not freeze. The drug vial should be protected from light by storing in the carton.

Discard unused portion.

📋 Description 207 words ▾

11 DESCRIPTION XIPERE ® is a sterile, injectable suspension of triamcinolone acetonide, a synthetic corticosteroid for suprachoroidal use with the SCS Microinjector ® . Each mL of the aqueous suspension contains 40 mg of triamcinolone acetonide with 0.55% (weight/volume [w/v]) sodium chloride for tonicity, 0.5% (w/v) carboxymethylcellulose sodium, and 0.02% (w/v) polysorbate 80. It also contains potassium chloride, calcium chloride (dihydrate) and magnesium chloride (hexahydrate) as isotonicity agents, sodium acetate trihydrate(3.51 mg), sodium citrate dihydrate(1.53 mg), and water for injection.

Hydrochloric acid may be used to adjust pH to a target value of 6.5. XIPERE ® does not contain an anti-microbial preservative. The chemical name for triamcinolone acetonide is 9-fluoro-11β,16ɑ,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone.

Its chemical structure is: Molecular weight 434.50; molecular formula C 24 H 31 FO 6 Triamcinolone acetonide occurs as a white to cream-colored, crystalline powder having not more than a slight odor and is practically insoluble in water and very soluble in alcohol. XIPERE ® is provided as an injectable suspension in a single-dose glass vial with a rubber stopper and an aluminum seal. The SCS Microinjector ® is a piston syringe and a needle approximately 1 mm in length (900-µm and 1100-µm needles are included) for conducting the suprachoroidal injection.

IMAGE 18

💬 Information for Patients 105 words ▾

17 PATIENT COUNSELING INFORMATION Corticosteroid-Related Effects Advise patients that they may develop elevated intraocular pressure following treatment, which may need to be managed with medication or surgery. When to Seek Physician Advice Advise patients that if the eye becomes red, sensitive to light, painful, or develops a change in vision, they should seek immediate care from an ophthalmologist. Distributed by: Bausch & Lomb Americas Inc.

Bridgewater, NJ 08807 USA Patented. See https://patents.bausch.com for US patent information. XIPERE ® , SCS ® , and SCS Microinjector ® are trademarks of Clearside Biomedical, Inc. used under license. © 2025 Bausch & Lomb Incorporated or its affiliates 9772102

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 24208-0023-01 · Bausch 24208-0092-05 · Bausch →
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.