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Cyclosporine .5 mg/mL Emulsion, 60 vials — NDC 10702-0808-06 package photo

Cyclosporine .5 mg/mL Emulsion, 60 vials

by KVK-TECH, INC. · 60 VIAL, SINGLE-USE in 1 TRAY (10702-808-06) / .4 mL in 1 VIAL, SINGLE-USE
NDC 10702-0808-06
🏷️ FDA NDC (as labeled) 10702-808-06 billing pads the product segment with a zero
This package
Contains60 vials Cost per ea$0.9240 NADAC Per package$55.44 / 60 vials Pack sizes2 compare ↓
Also priced by: Medicaid pays $2.69/unit · Part D plans $3.98/unit — full pricing hub ↓
Also comes in: 30 vials 10702-0808-03
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

🆔 Identity & classification

FDA NDC (as labeled) 10702-808-06
Product NDC 10702-808
11-digit billing NDC 10702080806
NCPDP billing unit EA — each (per item)
RxCUI 2572292
UNII 83HN0GTJ6D
UPC 0310702808034, 0310702808065
Application # NDA050790
SPL Set ID a7040dc6-063b-40ee-8f2a-153e87b08430
Established class (EPC) Calcineurin Inhibitor Immunosuppressant
Mechanism of action Calcineurin Inhibitors; Cytochrome P450 3A4 Inhibitors; P-Glycoprotein Inhibitors
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-02-10
Route OPHTHALMIC
Dosage form EMULSION
Substance CYCLOSPORINE
GPI-14 86720020001621
GPI class cycloSPORINE
GCN Seq No 051820
GCN 19216
HICL code 004524
Ingredient (HICL) Cyclosporine
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q2
Therapeutic class — intermediate (HIC2) Drugs Acting On The Eye
HIC3 code Q2C
Therapeutic class — specific (HIC3) Ophthalmic Anti-Inflammatory Immunomodulator-Type
AHFS code 52:08.00.00
AHFS class Anti-Inflammatory Agents (Eent)
FDB label name CYCLOSPORINE 0.05% EYE EMULS
FDB brand name Cyclosporine
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 10702-808-06 — 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 → 10702-0808-06. 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 Calcineurin Inhibitor Immunosuppressant class.

Pharmacologic class Calcineurin Inhibitor Immunosuppressant
Drug family (ATC) Calcineurin inhibitors, Other ophthalmologicals
How it works Calcineurin Inhibitors, Cytochrome P450 3A4 Inhibitors, P-Glycoprotein Inhibitors
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

LabelerKVK-TECH, INC.
Application holderABBVIE INC
FDA applicationNDA050790 (NDA AUTHORIZED GENERIC)
Labeler code10702
First marketedFeb 2022
Product typeHuman Prescription Drug
Portfolio58 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 CYCLOSPORINE 0.05% EYE EMULS Ingredient Cyclosporine
📗 Our plain-language guide HelloPharmacist
  • Cyclosporine levels in your blood can vary quite a bit, and both too much and too little can cause real problems — too high raises the risk of kidney damage, and too low means the...
  • Why do I need blood tests so often while taking cyclosporine?
  • No — grapefruit and grapefruit juice are a hard no with cyclosporine. They block a key enzyme in your body that normally clears cyclosporine, which can cause your blood levels to c...
  • Can I eat grapefruit while taking cyclosporine?
📖 Read our full Cyclosporine guide →
1
Nutrient depletion considerations

Cyclosporine may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Cyclosporine 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 71DD5V995L
    A synthetic polymer derived from acrylic acid, crosslinked to form a gel-like substance. It thickens formulations, improves texture, and helps distribute active ingredients evenly in topical products like creams and gels.
  • UNII D5340Y2I9G
    Castor oil is a natural plant-based oil used in medicines as a lubricant, laxative agent, and solvent. It helps medicine ingredients dissolve or flow smoothly and can aid bowel movement in formulations designed for that purpose.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • 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 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 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.

6 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 eaPer package
Retail pharmacies payNADAC · weekly $0.924 $55.44 / 60 vials
Medicaid paysCMS SDUD · 12 mo $2.69 $161.23 / 60 vials
Medicare drug plans payPart D · Q2 2026 $3.98 $238.91 / 60 vials
NADAC price history (per ea) — tap or hover for the price & month
Aug 2022 Jan 2024 Mar 2026 Aug 2026 $5.985 $0.924
▼ Down 85% over the last 16 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cyclosporine .5 mg/mLthis 10702-0808-06 KVK-TECH, 60 vials $0.924 AB Availability likely —
Cyclosporine .5 mg/mL 24979-0126-18 Upsher-Smith 60 vials $0.924 AB Availability likely —
Cyclosporine .5 mg/mL 00378-8760-58 Mylan 6 pouches $1.240 AB Availability likely +34%
Cyclosporine .5 mg/mL 00480-4076-30 Teva 6 pouches $1.240 AB Availability likely +34%
Cyclosporine .5 mg/mL 60505-6202-01 Apotex 30 vials $1.240 AB Availability likely +34%
Cyclosporine .5 mg/mL 68180-0214-30 Lupin 30 vials $1.240 AB Availability likely +34%
Cyclosporine .5 mg/mL 71656-0012-30 Saptalis 6 pouches $1.240 AB Availability likely +34%
Cyclosporine .5 mg/mL 73043-0005-01 Devatis 3 pouches $1.240 AB Availability likely +34%
Restasis MultiDose .5 mg/mL 00023-5301-05 Allergan, 1 bottle $112.318 AB Availability likely +12056%
Restasis .5 mg/mL 00023-9163-12 Allergan, 5 vials — AB FDA listed —
Restasis .5 mg/mL 50090-4476-00 A-S 30 vials — AB FDA listed —
Cyclosporine .5 mg/mL 69238-1023-03 Amneal 3 pouches — AB Discontinued —
About this product: this is an authorized generic — the brand-name product marketed without its brand name. Other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2002
First FDA approval
Dec 2002
📍
2026
Currently FDA-listed
24 years listed
🛡️
2034
Latest patent/protection listed
not a guaranteed launch date
✅Generic appears available

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

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through May 2034. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Dec 23, 2002 AB TE-rated RLD RS ⏳ ~7.7 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 8292129 — drug product
US 9676525 — drug product
US 9669974 — drug product
US 8561859 — drug product
2002 2004 2006 2008 2010 2012 2014 2016 2018 2020 2022 2024 2026 2028 2030 2032 2034
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 8292129 ↗ delist req. Drug product — Feb 25, 2031
US 9676525 ↗ delist req. Drug product — Feb 7, 2034
US 9669974 ↗ delist req. Drug product — May 11, 2034
US 8561859 ↗ delist req. Drug product — Apr 16, 2032
Common questions
Is there a generic version of CYCLOSPORINE 0.05% EYE EMULS?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for CYCLOSPORINE 0.05% EYE EMULS. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ 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 10702-0808-06, 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
8.8K
Units reimbursed last 4 qtrs
593.3K
Gross reimbursed last 4 qtrs
$1.59M
Avg / prescription
$182.05
Avg / unit
$2.6871
Latest quarter Q4 2025
1.7KRx
Medicaid pays / ea
$2.6871
gross reimbursed
vs
NADAC / ea
$0.9240
acquisition cost
=
Spread
+$1.7631
+191% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
17% FFS 83% MCO
Fee-for-service · 1,486 Rx Managed care · 7,271 Rx
State Medicaid map
Alaska: 5,520 units · 753 per 100k residents AK Maine: no data reported ME Washington: 68,280 units · 874 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 4,920 units · 85.8 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 64,860 units · 331 per 100k residents NY Vermont: no data reported VT New Hampshire: 9,420 units · 672 per 100k residents NH Oregon: 2,592 units · 61.2 per 100k residents OR Nevada: 37,680 units · 1,180 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 840 units · 26.2 per 100k residents IA Illinois: 3,780 units · 30.1 per 100k residents IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 1,380 units · 10.6 per 100k residents PA New Jersey: 43,140 units · 464 per 100k residents NJ Massachusetts: no data reported MA California: 13,080 units · 33.6 per 100k residents CA Utah: 960 units · 28.1 per 100k residents UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 27,780 units · 319 per 100k residents VA Maryland: 46,800 units · 757 per 100k residents MD Connecticut: 5,220 units · 144 per 100k residents CT Rhode Island: 51,060 units · 4,663 per 100k residents RI Arizona: 11,280 units · 152 per 100k residents AZ New Mexico: 792 units · 37.5 per 100k residents NM Kansas: 3,360 units · 114 per 100k residents KS Arkansas: no data reported AR Tennessee: 4,020 units · 56.4 per 100k residents TN North Carolina: 5,700 units · 52.6 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 16,380 units · 404 per 100k residents OK Louisiana: 43,860 units · 959 per 100k residents LA Mississippi: no data reported MS Alabama: 19,920 units · 390 per 100k residents AL Georgia: 3,420 units · 31.0 per 100k residents GA D.C.: 5,604 units · 825 per 100k residents DC Hawaii: 79,380 units · 5,532 per 100k residents HI Texas: 9,456 units · 31.0 per 100k residents TX Florida: 912 units · 4.0 per 100k residents FL
Units reimbursed · per 100k residents
4.05,532
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 Hawaii 5,532 /100k
2 Rhode Island 4,663 /100k
3 Nevada 1,180 /100k
4 Louisiana 959 /100k
5 Washington 874 /100k
6 D.C. 825 /100k
7 Maryland 757 /100k
8 Alaska 753 /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.
60 vials this page10702-0808-06 8,757 Rx · $1,594,225
30 vials10702-0808-03 1,262 Rx · $211,564
Drug total (last 4 qtrs): 10,019 Rx · 640,969 units · $1,805,789 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 · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Cyclosporine — the program that covers self-administered drugs. 7 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Cyclosporine. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$114.98M
Claims incl. refills
348.9K
Beneficiaries
241.6K
Spend / beneficiary
$475.87
Spend / claim
$329.58
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for CYCLOSPORINE — the ingredient across all brands.

Top reported reactions

Eye Irritation10,005
Eye Pain4,619
Pyrexia4,174
Headache3,888
Nausea3,776
Diarrhoea3,729
Fatigue3,507

Reporter sex

0 reports

Serious outcomes

Death14,510
Disabling1,989
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 11,081 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
10702-0808-03 30 VIAL, SINGLE-USE in 1 TRAY (10702-808-03) / .4 mL in 1 VIAL, SINGLE-USE $1.24 / ea $37.19 2022-02-10 Active
10702-0808-06 You're viewing this 60 VIAL, SINGLE-USE in 1 TRAY (10702-808-06) / .4 mL in 1 VIAL, SINGLE-USE $0.9240 / ea $55.44 2022-02-10 Active

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.9240 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 87% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 10702-0808-06?
NDC 10702-0808-06 contains 60 vials — 60 vial, single-use in 1 tray / .4 ml in 1 vial, single-use.
What is the difference between NDC 10702-0808-06 and NDC 10702-0808-03?
Both are Cyclosporine .5 mg/mL Emulsion — the drug itself is identical. NDC 10702-0808-06 is the 60 vials package, while NDC 10702-0808-03 is the 30 vials package. Per-ea NADAC also differs: $0.9240 here vs $1.24 for the 30 vials pack.
What NDC number is used to bill for this package of Cyclosporine .5 mg/mL Emulsion?
Bill NDC 10702-0808-06 — the 11-digit billing format is 10702080806. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 101 words ▾

1 INDICATIONS AND USAGE Cyclosporine ophthalmic emulsion, 0.05% is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs. Cyclosporine ophthalmic emulsion, 0.05% is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca.

Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs. ( 1 )

⏱️ Dosage and Administration 82 words ▾

2 DOSAGE AND ADMINISTRATION Invert the unit dose vial a few times to obtain a uniform, white, opaque emulsion before using. Instill one drop of cyclosporine ophthalmic emulsion, 0.05% twice a day in each eye approximately 12 hours apart. Cyclosporine ophthalmic emulsion can be used concomitantly with lubricant eye drops, allowing a 15-minute interval between products.

Discard vial immediately after use. Instill one drop of cyclosporine ophthalmic emulsion, 0.05% twice a day in each eye approximately 12 hours apart. ( 2 )

💊 Dosage Forms and Strengths 19 words ▾

3 DOSAGE FORMS AND STRENGTHS Ophthalmic emulsion containing cyclosporine 0.5 mg/mL Cyclosporine ophthalmic emulsion 0.5 mg/mL ( 3 )

⛔ Contraindications 26 words ▾

4 CONTRAINDICATIONS Cyclosporine ophthalmic emulsion is contraindicated in patients with known or suspected hypersensitivity to any of the ingredients in the formulation. Hypersensitivity ( 4 )

⚠️ Warnings and Cautions 116 words ▾

5 WARNINGS AND PRECAUTIONS To avoid the potential for eye injury and contamination, be careful not to touch the vial tip to your eye or other surfaces. ( 5.1 ) 5. 1 Potential for Eye Injury and Contamination Be careful not to touch the vial tip to your eye or other surfaces to avoid potential for eye injury and contamination.

5. 2 Use with Contact Lenses Cyclosporine ophthalmic emulsion should not be administered while wearing contact lenses. Patients with decreased tear production typically should not wear contact lenses.

If contact lenses are worn, they should be removed prior to the administration of the emulsion. Lenses may be reinserted 15 minutes following administration of cyclosporine ophthalmic emulsion.

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Potential for Eye Injury and Contamination [ see Warnings and Precautions ( 5.1 ) ] The most common adverse reaction following the use of -cyclosporine ophthalmic emulsion was ocular burning (17%). ( 6.1 ) To Report SUSPECTED ADVERSE REACTIONS, contact KVK-Tech, Inc. at 1-800-862-3895 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. In clinical trials, the most common adverse reaction following the use of cyclosporine ophthalmic emulsion was ocular burning (17%). Other reactions reported in 1% to 5% of patients included conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging, and visual disturbance (most often blurring).

6.2Post-marketing Experience The following adverse reactions have been identified during post approval use of cyclosporine ophthalmic emulsion. 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. Reported reactions have included: hypersensitivity (including eye swelling, urticaria, rare cases of severe angioedema, face swelling, tongue swelling, pharyngeal edema, and dyspnea); and superficial injury of the eye (from the vial tip touching the eye during administration).

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Clinical administration of cyclosporine ophthalmic emulsion 0.05% is not detected systemically following topical ocular administration [ see Clinical Pharmacology ( 12.3 ) ], and maternal use is not expected to result in fetal exposure to the drug. Oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses [ see Data ]. Data Animal Data At maternally toxic doses (30 mg/kg/day in rats and 100 mg/kg/day in rabbits), cyclosporine oral solution (USP) was teratogenic as indicated by increased pre- and postnatal mortality, reduced fetal weight and skeletal retardations.

These doses (normalized to body surface area) are 5,000 and 32,000 times greater, respectively, than the daily recommended human dose of one drop (approximately 28 mcL) of cyclosporine ophthalmic emulsion 0.05% twice daily into each eye of a 60 kg person (0.001 mg/kg/day), assuming that the entire dose is absorbed. No evidence of embryofetal toxicity was observed in rats or rabbits receiving cyclosporine during organogenesis at oral doses up to 17 mg/kg/day or 30 mg/kg/day, respectively. These doses in rats and rabbits are approximately 3,000 and 10,000 times greater, respectively, than the daily recommended human dose.

An oral dose of 45 mg/kg/day cyclosporine administered to rats from Day 15 of pregnancy until Day 21 postpartum produced maternal toxicity and an increase in postnatal mortality in offspring. This dose is 7,000 times greater than the daily recommended human dose. No adverse effects in dams or offspring were observed at oral doses up to 15 mg/kg/day (2,000 times greater than the daily recommended human dose).

8. 2 Lactation Risk Summary Cyclosporine is known to appear in human milk following systemic administration, but its presence in human milk following topical treatment has not been investigated. Although blood concentrations are undetectable following topical administration of cyclosporine ophthalmic emulsion [see Clinical Pharmacology ( 12.3 )] , caution should be exercised when cyclosporine ophthalmic emulsion is administered to a nursing woman.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for cyclosporine ophthalmic emulsion and any potential adverse effects on the breast-fed child from cyclosporine.

8.4Pediatric Use Safety and efficacy have not been established in pediatric patients below the age of 16.

8.5Geriatric Use No overall difference in safety or effectiveness has been observed between elderly and younger patients.

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Clinical administration of cyclosporine ophthalmic emulsion 0.05% is not detected systemically following topical ocular administration [ see Clinical Pharmacology ( 12.3 ) ], and maternal use is not expected to result in fetal exposure to the drug. Oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses [ see Data ]. Data Animal Data At maternally toxic doses (30 mg/kg/day in rats and 100 mg/kg/day in rabbits), cyclosporine oral solution (USP) was teratogenic as indicated by increased pre- and postnatal mortality, reduced fetal weight and skeletal retardations.

These doses (normalized to body surface area) are 5,000 and 32,000 times greater, respectively, than the daily recommended human dose of one drop (approximately 28 mcL) of cyclosporine ophthalmic emulsion 0.05% twice daily into each eye of a 60 kg person (0.001 mg/kg/day), assuming that the entire dose is absorbed. No evidence of embryofetal toxicity was observed in rats or rabbits receiving cyclosporine during organogenesis at oral doses up to 17 mg/kg/day or 30 mg/kg/day, respectively. These doses in rats and rabbits are approximately 3,000 and 10,000 times greater, respectively, than the daily recommended human dose.

An oral dose of 45 mg/kg/day cyclosporine administered to rats from Day 15 of pregnancy until Day 21 postpartum produced maternal toxicity and an increase in postnatal mortality in offspring. This dose is 7,000 times greater than the daily recommended human dose. No adverse effects in dams or offspring were observed at oral doses up to 15 mg/kg/day (2,000 times greater than the daily recommended human dose).

🧒 Pediatric Use 18 words ▾

8.4Pediatric Use Safety and efficacy have not been established in pediatric patients below the age of 16.

🧓 Geriatric Use 18 words ▾

8.5Geriatric Use No overall difference in safety or effectiveness has been observed between elderly and younger patients.

🧬 Clinical Pharmacology 120 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Cyclosporine is an immunosuppressive agent when administered systemically. In patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca, cyclosporine emulsion is thought to act as a partial immunomodulator. The exact mechanism of action is not known.

12.3Pharmacokinetics Blood cyclosporine A concentrations were measured using a specific high pressure liquid chromatography-mass spectrometry assay. Blood concentrations of cyclosporine, in all the samples collected, after topical administration of cyclosporine ophthalmic emulsion, 0.05%, twice daily, in humans for up to 12 months, were below the quantitation limit of 0.1 ng/mL. There was no detectable drug accumulation in blood during 12 months of treatment with cyclosporine ophthalmic emulsion, 0.05%.

🧬 Mechanism of Action 48 words ▾

12.1Mechanism of Action Cyclosporine is an immunosuppressive agent when administered systemically. In patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca, cyclosporine emulsion is thought to act as a partial immunomodulator. The exact mechanism of action is not known.

📦 How Supplied / Storage and Handling 79 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Cyclosporine ophthalmic emulsion, 0.05% is packaged in sterile, preservative-free single-use vials. Each vial contains 0.4 mL fill in a 0.9 mL LDPE vial; 30 or 60 vials are packaged in a polypropylene tray with an aluminum peelable lid. The entire contents of each tray (30 vials or 60 vials) must be dispensed intact.

30 Vials 0.4 mL each - NDC 10702-808-03 60 Vials 0.4 mL each - NDC 10702-808-06 Storage: Store at 15°-25°C (59°-77°F).

📋 Description 124 words ▾

11 DESCRIPTION Cyclosporine ophthalmic emulsion, 0.05% contains a topical calcineurin inhibitor immunosuppressant with anti-inflammatory effects. Cyclosporine’s chemical name is Cyclo[[( E )-(2 S ,3 R ,4 R )-3-hydroxy-4-methyl-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl- N -methylglycyl- N -methyl-L-leucyl-L-valyl- N -methyl-L-leucyl-L-alanyl-D-alanyl- N -methyl-L-leucyl- N -methyl-L-leucyl- N -methyl-L-valyl] and it has the following structure: Structural Formula Formula: C 62 H 111 N 11 O 12 Mol. Wt.: 1202.6 Cyclosporine is a fine white powder.

Cyclosporine ophthalmic emulsion appears as a white opaque to slightly translucent homogeneous emulsion. It has an osmolality of 230 to 320 mOsmol/kg and a pH of 6.5-8.0. Each mL of cyclosporine ophthalmic emulsion, 0.05% contains: Active: cyclosporine 0.05%.

Inactives : glycerin; castor oil; polysorbate 80; carbomer copolymer type A; purified water; and sodium hydroxide to adjust pH. cyclosporine

💬 Information for Patients 177 words ▾

17 PATIENT COUNSELING INFORMATION Handling the Container Advise patients to not allow the tip of the vial to touch the eye or any surface, as this may contaminate the emulsion. Advise patients to not touch the vial tip to their eye to avoid the potential for injury to the eye [ see Warnings and Preca u tions ( 5.1 ) ]. Use with Contact Lens es Cyclosporine ophthalmic emulsion should not be administered while wearing contact lenses.

Patients with decreased tear production typically should not wear contact lenses. Advise patients that if contact lenses are worn, they should be removed prior to the administration of the emulsion. Lenses may be reinserted 15 minutes following administration of cyclosporine ophthalmic emulsion [ see Warnings and Precautions ( 5.2 ) ].

Administration Advise patients that the emulsion from one individual single-use vial is to be used immediately after opening for administration to one or both eyes, and the remaining contents should be discarded immediately after administration. Distributed by: KVK-Tech, INC. Newtown, PA 18940 © 2024 AbbVie.

All rights reserved. v2.0USPI10702AG

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