TRYPTYR Acoltremon .03 mg/mL Solution — NDC 0065-8595-01 (Billing 00065-8595-01)
This is a package of TRYPTYR Acoltremon .03 mg/mL Solution from Alcon Laboratories, Inc., marketed since Jul 2025 and currently FDA-listed.
NDC database record
One package, one record: these facts belong to NDC 0065-8595-01 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0065 labeler · 8595 product · 01 package
- Package marketed since
- Jul 23, 2025
- Sample package
- Yes — professional sample, not for sale
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 0065859501 0
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 087816
- GCN: 57839
- GPI-14 (Medi-Span): 86805310002020
- HICL (First Databank): 050621
- AHFS class code: 52:92.00.00
- RxCUI (RxNorm): 2716821
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the TRPM8 Thermoreceptor Agonist class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Acoltremon ophthalmic solution is used to treat signs and symptoms of dry eye disease (a condition where tears aren't able to provide adequate moisture for your eyes). Acoltremon is in a class of medications called transient receptor potential melastatin 8 (TRPM8) agonists. It works by increasing tear production.
Read the full MedlinePlus article ↗Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $15.06 | $90.38 / 6 ml |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 8, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 00065-8595-01 You're viewing this | 3 POUCH in 1 CARTON / 5 VIAL in 1 POUCH / .4 mL in 1 VIAL Sample | — | — | 2025-07-23 | — | Active |
| 00065-8595-02 0065-8595-02 Main listing | 12 POUCH in 1 CARTON / 5 VIAL in 1 POUCH / .4 mL in 1 VIAL | $14.09 / ea | $845.18 | 2025-07-23 | — | Active |
This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of TRYPTYR Acoltremon .03 mg/mL Solution?
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.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Tryptyr .03 mg/mLthis 00065-8595-01 | Alcon | 3 pouches | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
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.
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.
🛈 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.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 11850221 ↗ | Method of use | U-1900 | Dec 16, 2042 |
| US 10028920 ↗ | Method of use | U-1900 | Sep 8, 2031 |
| US 9433679 ↗ | Method of use | U-1900 | Sep 8, 2031 |
| US 9095609 ↗ | Method of use | U-1900 | Sep 8, 2031 |
| US 12336971 ↗ | Method of use | U-1900 | Dec 16, 2042 |
| Code | What it grants | Expires |
|---|---|---|
| NCE | New Chemical Entity (5-year) | May 28, 2030 |
Is there a generic version of TRYPTYR 0.003% EYE DROP?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
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.
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UNII 5EYA69XGAT
Hypromellose is a plant-derived thickener and film-former used in medicine coatings and tablets. It helps control how fast the drug dissolves and protects the medicine's contents.
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UNII 6D4M1DAL6O
Polyoxyl 35 castor oil is a synthetic compound made by chemically treating castor oil. It works as a solubilizer and emulsifier to help dissolve and evenly mix oily and water-based ingredients in medicines.
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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.
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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.
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UNII 5QWK665956
A salt derived from phosphoric acid and sodium, used primarily as a buffer to control the acidity or pH of a medication, helping keep it stable during storage and use.
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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?
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.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Alcon Laboratories, Inc. labeler code 00065
- SIMBRINZA brinzolamide/brimonidine tartrate 10 mg/mL; 2 mg/mL Suspension/ Drops NDC 0065-4147-25
- PATADAY TWICE A DAY RELIEF OLOPATADINE HYDROCHLORIDE 1 mg/mL Solution NDC 0065-4274-01
- GenTeal Tears Moderate Preservative Free dextran 70, hypromellose 2910 2910 (4000 MPA.S) 3 mg/mL; 70 1 mg/mL Solution/ Drops NDC 0065-8063-01
- GenTeal Tears Severe Hypromellose 2910 (4000 MPA.S) .003 g/g Gel NDC 0065-8064-01
- GenTeal Tears Gel Drops polyethylene glycol 400 and propylene 400 4 mg/mL; 3 mg/mL Gel NDC 0065-8067-01
- PATADAY ONCE DAILY RELIEF OLOPATADINE HYDROCHLORIDE 2 mg/mL Solution NDC 0065-8150-01
- BION TEARS Dextran, Hypromellose 70 1 mg/mL; 2910 (4000 MPA.S) 3 mg/mL Solution/ Drops NDC 0065-9305-01
- Inveltys Loteprednol Etabonate 10 mg/mL Suspension NDC 0065-9307-04
- Systane Pro PF Propylene Glycol 6 mg/mL Emulsion NDC 0065-9308-05
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE TRYPTYR is indicated for the treatment of the signs and symptoms of dry eye disease. TRYPTYR is a TRPM8 thermoreceptor agonist indicated for the treatment of the signs and symptoms of dry eye disease. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Instill one drop in each eye twice daily (approximately 12 hours apart). ( 2 )
2.1Recommended Dosage Instill one drop in each eye twice daily (approximately 12 hours apart).
2.2Administration Instructions Wash hands before use. The single-dose vials are to be used immediately after opening and can be used to dose both eyes. Discard the single-dose vial, including any remaining contents, immediately after use.
TRYPTYR can be used concomitantly with other topical ophthalmic eye drops. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart . Contact lenses should be removed prior to the administration of TRYPTYR and may be reinserted 15 minutes following administration.
If one dose is missed, treatment should continue with the next dose.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS TRYPTYR is a clear to slightly opalescent, colorless ophthalmic solution containing 0.003% acoltremon in a single-dose vial. Ophthalmic solution: 0.003% acoltremon in a single-dose vial. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS To avoid the potential for eye injury and contamination, do not touch the vial tip to the eye or other surfaces. ( 5.1 )
5.1Potential for Eye Injury and Contamination To avoid the potential for eye injury and contamination, do not touch the vial tip to the eye or other surfaces.
5.2Use with Contact Lenses TRYPTYR should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of TRYPTYR.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common adverse reaction was instillation site pain (50%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc. at 1-800-757-9780, 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 patients with dry eye disease, 766 patients received at least one dose of TRYPTYR in four randomized controlled clinical trials across 71 sites in the United States. The most common ocular adverse reaction observed in controlled clinical studies with TRYPTYR was instillation site pain (50%).
Less than 1% of patients discontinued therapy due to burning or stinging sensation in the eyes.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no adequate and well-controlled studies on TRYPTYR in pregnant women. Systemic exposure to acoltremon from ocular administration is negligible [see Clinical Pharmacology ( 12.3 )] . Intravenous administration of acoltremon to pregnant rats and rabbits during organogenesis did not produce embryofetal toxicity at 806- and 2151-fold the maximum recommended human ocular dose (MRHOD) of acoltremon on a mg/m 2 basis ( see Data ) .
All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies. Data Animal Data In embryofetal developmental studies in pregnant rats and rabbits dosed by intravenous injection daily during organogenesis from gestation days 6-17 and gestation days 7-19, respectively, no maternal or fetal toxicity was observed at 806- and 2151-fold the MRHOD of acoltremon on a mg/m 2 basis.
8.2Lactation Risk Summary There are no data on the presence of acoltremon in human milk, the effects on the breastfed infant, or the effects on milk production. However, systemic exposure to acoltremon following topical ocular administration is low. The lack of clinical data during lactation precludes a clear determination of the risk of TRYPTYR to an infant during lactation; however, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TRYPTYR.
8.4Pediatric Use The safety and effectiveness of TRYPTYR have not been established in pediatric patients.
8.5Geriatric Use No clinically relevant differences in safety have been observed between elderly and younger patients.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no adequate and well-controlled studies on TRYPTYR in pregnant women. Systemic exposure to acoltremon from ocular administration is negligible [see Clinical Pharmacology ( 12.3 )] . Intravenous administration of acoltremon to pregnant rats and rabbits during organogenesis did not produce embryofetal toxicity at 806- and 2151-fold the maximum recommended human ocular dose (MRHOD) of acoltremon on a mg/m 2 basis ( see Data ) .
All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies. Data Animal Data In embryofetal developmental studies in pregnant rats and rabbits dosed by intravenous injection daily during organogenesis from gestation days 6-17 and gestation days 7-19, respectively, no maternal or fetal toxicity was observed at 806- and 2151-fold the MRHOD of acoltremon on a mg/m 2 basis.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of TRYPTYR have not been established in pediatric patients.
🧓 Geriatric Use ▾
8.5Geriatric Use No clinically relevant differences in safety have been observed between elderly and younger patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Studies in animals suggest that acoltremon, the active substance in TRYPTYR, is an agonist of transient receptor potential melastatin 8 (TRPM8) thermoreceptors. TRPM8 thermoreceptor stimulation has been shown to activate trigeminal nerve signaling leading to increased basal tear production. The exact mechanism of action for TRYPTYR in dry eye disease is unknown.
12.3Pharmacokinetics PK was assessed in 25 patients with dry eye disease receiving TRYPTYR administration (1 drop twice daily) on Days 1, 14, and 90. A total of three (3) (12.0%) had plasma concentrations above 20 pg/mL (the lower limit of quantification), with the highest plasma concentration of 213 pg/mL.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Studies in animals suggest that acoltremon, the active substance in TRYPTYR, is an agonist of transient receptor potential melastatin 8 (TRPM8) thermoreceptors. TRPM8 thermoreceptor stimulation has been shown to activate trigeminal nerve signaling leading to increased basal tear production. The exact mechanism of action for TRYPTYR in dry eye disease is unknown.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING TRYPTYR (acoltremon ophthalmic solution) 0.003% is supplied as a sterile, clear to slightly opalescent, and colorless solution in a low-density polyethylene (LDPE), single-dose vial with a 0.4 mL fill. One strip of 5 single-dose vials is packaged in a foil pouch with twelve (12) pouches in a carton. NDC 0065-8595-02; Carton of 60 Single-Dose Vials.
Storage Store refrigerated at 2°C to 8°C (36°F to 46°F). After opening the carton, TRYPTYR may be stored refrigerated or at room temperature at 2°C to 25°C (36°F to 77°F). If stored at room temperature, TRYPTYR should be used within 30 days, not to exceed the expiration date printed on the carton and foil pouch.
After opening each foil pouch, the single-dose vials should be used within 7 days, not to exceed the expiration date printed on the vial. Store unopened single-dose vials in the original foil pouch until ready to use.
📋 Description ▾
11 DESCRIPTION TRYPTYR (acoltremon ophthalmic solution) 0.003% contains an agonist of TRPM8 ion channels. Acoltremon’s chemical name is (1 R ,2 S ,5 R )-2-isopropyl- N -(4-methoxyphenyl)-5-methylcyclohexane-1-carboxamide. The molecular formula of acoltremon is C 18 H 27 NO 2 and has a molecular weight of 289.42 g/mol.
Acoltremon is a white to pale yellow crystalline solid, that is insoluble in water. TRYPTYR is a sterile, clear to slightly opalescent, colorless, isotonic aqueous solution for topical ophthalmic use, with a pH of approximately 7 and an osmolality of 280 to 330 mOsm/kg. Each mL of TRYPTYR contains active: acoltremon 0.003%; and inactives: polyoxyl 35 castor oil, sodium dihydrogen phosphate dihydrate, sodium chloride, hypromellose and purified water.
Additionally, sodium hydroxide is used to adjust pH. TRYPTYR does not contain an anti-microbial preservative.
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics PK was assessed in 25 patients with dry eye disease receiving TRYPTYR administration (1 drop twice daily) on Days 1, 14, and 90. A total of three (3) (12.0%) had plasma concentrations above 20 pg/mL (the lower limit of quantification), with the highest plasma concentration of 213 pg/mL.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES The efficacy of TRYPTYR for the treatment of dry eye disease was supported by two randomized, multi-center, double-masked, vehicle-controlled studies (COMET-2 [NCT-05285644] and COMET-3 [NCT-05360966]) enrolling a total of 931 dry eye patients (462 of which received TRYPTYR). Patients were randomized to TRYPTYR or vehicle (placebo) in a 1:1 ratio and dosed twice a day for 90 days. Use of artificial tears was not allowed during the studies.
The mean age was 61 years (range, 30-93 years). The majority of patients were female (74.8%). Enrollment criteria included signs (i.e., corneal fluorescein staining score [2-15] and anesthetized Schirmer tear test [2-9 mm]) and symptoms (i.e., SANDE Score [≥ 50] and Ocular Discomfort Score [≥ 50]) of dry eye disease.
Efficacy Tear film production was measured by unanesthetized Schirmer tear test assessed using a Schirmer strip (0 - 35 mm). The average baseline unanesthetized Schirmer scores for TRYPTYR and Vehicle treated patients was 6.2 mm and 5.9 mm in the COMET-2 study, and 6.8 mm and 6.4 mm in the COMET-3 study, respectively. Of the patients treated at Day 14 (primary endpoint) with TRYPTYR, 42.6% achieved ≥ 10 mm increase in Schirmer score from baseline in the COMET-2 study and 53.2% achieved ≥ 10 mm increase in Schirmer score from baseline at Day 14 in the COMET-3 study, compared to 8.2% and 14.4% of vehicle-treated patients in the COMET-2 study and the COMET-3 study, respectively.
A statistically significant improvement in tear production favoring TRYPTYR (p<0.01) was observed in both studies ( Table 1 ). Table 1: Percent of Patients Achieving ≥ 10 mm Improvement from Baseline in Schirmer Score at Day 14 in Patients with Dry Eye Disease Tear Production COMET-2 COMET-3 TRYPTYR N = 230 Vehicle N = 235 TRYPTYR N = 232 Vehicle N = 234 ≥ 10 mm increase in tear production at Day 14 42.6% 8.2% 53.2% 14.4% Difference (95% CI) 34.4% (26.9, 42.0) 38.8% (30.8, 46.8) P-value versus vehicle < 0.01 <
0.01Consistent results were observed at all timepoints through Day 90.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity Long term studies in animals have not been performed to evaluate the carcinogenic potential of acoltremon. Mutagenicity Acoltremon was not mutagenic or clastogenic in the standard battery of genotoxicity tests including a bacterial reverse mutation assay, an in vitro chromosomal aberration assay in human peripheral lymphocytes and micronucleus assay in rats. Impairment of Fertility Studies to evaluate the potential effects of acoltremon on male or female fertility in animals have not been performed.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity Long term studies in animals have not been performed to evaluate the carcinogenic potential of acoltremon. Mutagenicity Acoltremon was not mutagenic or clastogenic in the standard battery of genotoxicity tests including a bacterial reverse mutation assay, an in vitro chromosomal aberration assay in human peripheral lymphocytes and micronucleus assay in rats. Impairment of Fertility Studies to evaluate the potential effects of acoltremon on male or female fertility in animals have not been performed.
📄 Patient Package Insert ▾
INSTRUCTIONS FOR USE SECTION INSTRUCTIONS FOR USE TRYPTYR® [trip’tir] (acoltremon ophthalmic solution) 0.003% for topical ophthalmic use This Instructions for Use contains information on how to use TRYPTYR. Read this Instructions for Use before you start using TRYPTYR and each time you get a refill. There may be new information.
This leaflet does not take the place of talking to your healthcare provider about your medical condition or your treatment. Important Information You Need to Know Before Using TRYPTYR : Use TRYPTYR exactly as your healthcare provider tells you to. TRYPTYR is for use in the eye.
Each single-dose vial of TRYPTYR will give you enough medicine to treat both of your eyes. There is extra TRYPTYR in each single-dose vial in case you miss getting a drop into your eye. Keep the unopened single-dose vials in the original foil package until ready to use.
Wash your hands before each use to make sure you do not infect your eyes. If you use TRYPTYR with other eye medicines, wait at least 5 minutes between using TRYPTYR and the other medicines. If you wear contact lenses, remove them before using TRYPTYR.
Wait 15 minutes after dosing before putting contact lenses back in your eyes. If 1 dose is missed, treatment should continue at the next scheduled time. Use 1 drop of TRYPTYR in each eye 2 times each day.
Use 1 single-dose vial in the morning and another single-dose vial in the evening, approximately 12 hours apart. Do not let the tip of the single-dose vial touch your eye or any other surface to avoid eye injury or infection. Do not use the single-dose vial or the medicine inside it if the tip touches your eye or another surface.
Throw it away. TRYPTYR vial is for 1-time use only. Use right away after opening and do not reuse.
Call your healthcare provider right away if you get an allergic reaction or other eye problems such as eye injury, eye infection, or eye pain. For additional safety information, see the Full Prescribing Information and talk with your healthcare provider. Follow steps 1 to 15 each time you use TRYPTYR Step 1 Remove the unopened carton from the refrigerator (see Figure A).
Check the expiration date printed on the carton. Write the date the carton is first opened in the space provided on the carton. Step 2 Open the carton.
Preparing a single-use vial Step 3 Wash your hands before each use to make sure you do not infect your eyes (see Figure B). Step 4 Take a foil pouch out of the TRYPTYR carton. Write the date the foil pouch is first opened in the space provided.
Tear open the pouch (see Figure C). Step 5 Remove the strip of 5 single-dose vials from the foil pouch (see Figure D). Step 6 Pull off one single-dose vial from the strip (see Figure E).
Place remaining vials back in the carton. Store carton at room temperature or place the carton back in the refrigerator. Step 7 Open the TRYPTYR single-dose vial by twisting off the tab at the top while holding the vial upright (see Figure F).
Do not touch the tip of the single-dose vial or allow it to touch any surface to avoid possible eye infection. Applying a dose of TRYPTYR to your eyes Step 8 Tilt your head backwards. If you are not able to tilt your head, lie down.
Step 9 Gently pull your lower eyelid downwards and look up. Step 10 Place the tip of the TRYPTYR single-dose vial close to your eye. Do not allow the tip of the vial to touch your eye to avoid eye injury or infection.
Step 11 Gently squeeze the single-dose vial and let 1 full drop of TRYPTYR coat your eye (see Figure G and G1 below). If a drop misses your eye, try again. After the drop is in your eye, gently close (do not squeeze) your eye for a few seconds.
Step 12 Repeat Steps 8 through 11 for your other eye. There is enough TRYPTYR in 1 single-dose vial for both eyes. After dosing and disposal instructions Step 13 After you have applied a drop to both eyes, throw away the opened single-dose vial with any remaining solution right away (see Figure H).
Do not reuse vial. Step 14 Wait a… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL TRYPTYR ® (acoltremon ophthalmic solution) 0.003% 3390 Alcon Lot: Exp.: NDC 0065-8595-02 441121 Rx only TRYPTYR ® (acoltremon ophthalmic solution) 0.003% For topical use in eye Recommended Dosage: Place one drop in each eye twice daily (approximately 12 hours apart). Discard single-dose vial immediately after use. Do not reuse.
Store in foil pouch until ready for use. After opening the foil pouch, TRYPTYR can be stored refrigerated or at room temperature, 2°C to 25°C (36°F to 77°F), and used within 7 days. Date of first opening _____/_____/_____ Contains 5 single-use vials (0.4 mL each) Sterile; Does not contain anti-microbial preservatives Alcon LOT: ####A EXP.: YYYY-MM Manufactured for: Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA NDC 0065-8595-02 Rx only TRYPTYR ® (acoltremon ophthalmic solution) 0.003% For topical application in the eye 60 SINGLE-DOSE VIALS ● 30-Day SUPPLY Does not contain anti-microbial preservatives Sterile Alcon CONTAINS 12 pouches x 5 single-dose vials (0.4 mL each) Each mL contains: Active: acoltremon 0.003% Inactives: polyoxyl 35 castor oil, sodium dihydrogen phosphate dihydrate, sodium chloride, hypromellose, sodium hydroxide to adjust pH, and purified water. STORAGE Store unopened carton in the refrigerator, 2°C to 8°C (36°F to 46°F).
After opening, TRYPTYR can be stored refrigerated or at room temperature up to 30 days in the unopened foil pouch, 2°C to 25°C (36°F to 77°F). Date carton first opened ___/___/___ See additional discard instructions on the pouch. DOSING Recommended Dosage: Place one drop in each eye twice daily (approximately 12 hours apart).
To avoid contamination, do not touch tip of container to any surface. Use one single-dose vial immediately after opening and then discard. Do not reuse.
Please see full Prescribing Information and Instructions for Use, inside carton, for additional dosage, storage and safety information. Manufactured in France for Alcon Laboratories, Inc. Fort Worth, TX 76134 USA Product of India U.S.
Pat.: www.alconpatents.com NDC 0065-8595-02 GTIN: 00300658595027 LOT: ####A EXP.: YYYY-MM SN: 01234567891234 TRYPTYR ® (acoltremon ophthalmic solution) 0.003% 439701
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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 | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |