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Rocklatan netarsudil and latanoprost ophthalmic solution, 0.02%/0.005% .2 mg/mL; .05 mg/mL Solution/ Drops, 1 bottle — NDC 70727-0529-99 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Rocklatan netarsudil and latanoprost ophthalmic solution, 0.02%/0.005% .2 mg/mL; .05 mg/mL Solution/ Drops, 1 bottle — NDC 70727-529-99 (Billing 70727-0529-99)

by Alcon Laboratories, Inc. · 1 BOTTLE, PLASTIC in 1 CARTON / 2.5 mL in 1 BOTTLE, PLASTIC

This is a package of 1 bottle of Rocklatan netarsudil and latanoprost ophthalmic solution, 0.02%/0.005% .2 mg/mL; .05 mg/mL Solution/ Drops from Alcon Laboratories, Inc., marketed since Mar 2019 and currently FDA-listed.

NDC 70727-0529-99
🏷️ FDA NDC (as labeled) 70727-529-99 billing pads the product segment with a zero
This package
Contains1 bottle Pack sizes2 compare ↓
Also priced by: Part D plans $140.18/unit — full pricing hub ↓
Product page 70727-0529-25 Also comes in: 2.5 mL 70727-529-25
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 17, 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70727-529-99
Product NDC 70727-529
11-digit billing NDC 70727052999
RxCUI 2119701, 2119706
UNII VL756B1K0U, 6Z5B6HVF6O
UPC 0370727529253
Application # NDA208259
SPL Set ID b1d71f41-be06-4a08-94d4-e352198f09c2
Established class (EPC) Prostaglandin Analog
Chemical class Prostaglandins
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-03-12
Route OPHTHALMIC, TOPICAL
Dosage form SOLUTION/ DROPS
Substance NETARSUDIL MESYLATE; LATANOPROST

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

GCN Seq No 079572
GCN 46097
HICL code 045645
Ingredient (HICL) Netarsudil Mesylat/Latanoprost
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 Q6G
Therapeutic class — specific (HIC3) Miotics And Other Intraocular Pressure Reducers
AHFS code 52:40.28.00
AHFS class Prostaglandin Analogs
FDB label name ROCKLATAN 0.02%-0.005% EYE DRP
FDB brand name Rocklatan
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 079572
  • GCN: 46097
  • HICL (First Databank): 045645
  • AHFS class code: 52:40.28.00
  • RxCUI (RxNorm): 2119701
Why two NDCs? The FDA registers this code as 70727-529-99 — 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 → 70727-0529-99. 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 Rho Kinase Inhibitor class.

Pharmacologic class Rho Kinase Inhibitor
Drug family (ATC) Other antiglaucoma preparations, Prostaglandin analogues
How it works Rho Kinase 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.

Clinical

Label name ROCKLATAN 0.02%-0.005% EYE DRP Ingredient Netarsudil Mesylat/Latanoprost

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

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

Price systemPer mLPer 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 $140.18 $350.45 / 2.5 ml
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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
70727-0529-25 70727-529-25 Main listing 1 BOTTLE, PLASTIC in 1 CARTON / 2.5 mL in 1 BOTTLE, PLASTIC $139.40 / mL $348.51 2019-03-12 — Active
70727-0529-99 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON / 2.5 mL in 1 BOTTLE, PLASTIC Sample — — 2019-03-12 — 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?
This package contains 1 bottle — 1 bottle, plastic in 1 carton / 2.5 ml in 1 bottle, plastic.
How does this package differ from NDC 70727-0529-25?
Both are Rocklatan netarsudil and latanoprost ophthalmic solution, 0.02%/0.005% .2 mg/mL; .05 mg/mL Solution/ Drops — the drug itself is identical. This page's package is the 1 bottle one, while NDC 70727-0529-25 is the 1 bottle package.
What NDC number is used to bill for this package of Rocklatan netarsudil and latanoprost ophthalmic solution, 0.02%/0.005% .2 mg/mL; .05 mg/mL Solution/ Drops?
Use the 11-digit billing form listed in the identifiers section of this page. 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rocklatan .2 mg/mL; .05 mg/mLthis 70727-0529-99 Alcon 1 bottle — — 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

🏛️
2019
First FDA approval
Mar 2019
📍
2026
Currently FDA-listed
7 years listed
🛡️
2034
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 Mar 2034. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Mar 12, 2019 RLD RS ⏳ ~7.4 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 9993470 — drug substance (U-1524)
US 9931336 — drug substance (U-1524)
US 10174017 — drug substance (U-1524)
US 9096569 — drug substance (U-1524)
US 8450344 — drug substance (U-1524)
US 10882840 — method of use (U-1524)
US 10532993 — method of use (U-1524)
US 10588901 — drug substance (U-1524)
US 11618748 — method of use (U-1524)
US 11020385 — method of use (U-1524)
US 8394826 — drug substance (U-1524)
US 10654844 — drug substance (U-1524)
US 11028081 — method of use (U-1524)
US 11021456 — method of use (U-1524)
US 11185538 — drug product
US 11197853 — drug product
US 9415043 — drug substance
2019 2021 2023 2025 2027 2029 2031 2033
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 (17)
PatentTypeUse codeExpires
US 9993470 ↗ Drug substance U-1524 Mar 14, 2034
US 9931336 ↗ Drug substance U-1524 Mar 14, 2034
US 10174017 ↗ Drug substance U-1524 Jan 27, 2030
US 9096569 ↗ Drug substance U-1524 Jul 11, 2026
US 8450344 ↗ Drug substance U-1524 Jul 11, 2026
US 10882840 ↗ Method of use U-1524 Jul 11, 2026
US 10532993 ↗ Method of use U-1524 Jul 11, 2026
US 10588901 ↗ Drug substance U-1524 Mar 14, 2034
US 11618748 ↗ Method of use U-1524 Jan 27, 2030
US 11020385 ↗ Method of use U-1524 Mar 14, 2034
US 8394826 ↗ Drug substance U-1524 Nov 10, 2030
US 10654844 ↗ Drug substance U-1524 Jan 27, 2030
US 11028081 ↗ Method of use U-1524 Jan 27, 2030
US 11021456 ↗ Method of use U-1524 Jul 11, 2026
US 11185538 ↗ Drug product — Mar 14, 2034
US 11197853 ↗ Drug product — Mar 14, 2034
US 9415043 ↗ Drug substance — Mar 14, 2034
Common questions
Is there a generic version of ROCKLATAN 0.02%-0.005% EYE DRP?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for ROCKLATAN 0.02%-0.005% EYE DRP. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Mar 2034 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

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

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

  • UNII F5UM2KM3W7
    Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
  • UNII R57ZHV85D4
    Boric acid is a weak acid derived from boron. In medicines, it typically serves as a buffer to help maintain the product's pH level and may act as a preservative in certain formulations.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • 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.

5 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.

Manufacturer & labeler

LabelerAlcon Laboratories, Inc.
Application holderALCON LABORATORIES INC
FDA applicationNDA208259 (NDA)
Labeler code70727
First marketedMar 2019
Product typeHuman Prescription Drug
Portfolio55 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 76 words ▾

1. INDICATIONS AND USAGE ROCKLATAN is a fixed dose combination of a Rho kinase inhibitor and a prostaglandin F 2α analogue indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. ROCKLATAN ® is a fixed dose combination of a Rho kinase inhibitor and a prostaglandin F 2α analogue indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

( 1 )

⏱️ Dosage and Administration 92 words ▾

2. DOSAGE AND ADMINISTRATION The recommended dosage is one drop in the affected eye(s) once daily in the evening. If one dose is missed, treatment should continue with the next dose in the evening.

The dosage of ROCKLATAN should not exceed once daily. ROCKLATAN may be used concomitantly with other topical ophthalmic drug products to lower IOP. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart.

One drop in the affected eye(s) once daily in the evening. ( 2 )

💊 Dosage Forms and Strengths 28 words ▾

3. DOSAGE FORMS AND STRENGTHS Ophthalmic solution containing netarsudil 0.02% (0.2 mg/mL) and latanoprost 0.005% (0.05 mg/mL). Ophthalmic solution containing netarsudil 0.02% and latanoprost 0.005%. ( 3 )

⛔ Contraindications 7 words ▾

4. CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5. WARNINGS AND PRECAUTIONS • Pigmentation : Pigmentation of the iris, periorbital tissue (eyelid) and eyelashes can occur. Iris pigmentation likely to be permanent. ( 5.2 ) • Eyelash Changes : Gradual change to eyelashes including increased length, thickness and number of lashes. Usually reversible. ( 5.3 )

5.1Epithelial Corneal Edema ROCKLATAN contains netarsudil which has been associated with Epithelial corneal edema, described as honeycomb or bullous, and has been reported in some patients with pre-existing corneal stromal edema or following ocular procedures that could affect corneal endothelial function. Epithelial corneal edemal typically resolves upon discontinuation of ROCKLATAN. Advise patients to notify their physician if they experience eye pain or decreased vision while using ROCKLATAN [see Adverse Reactions ( 6.2 ) and Patient Counselling Information ( 17 )] .

5.2Pigmentation ROCKLATAN contains latanoprost which has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase as long as latanoprost is administered.

The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. After discontinuation of latanoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Patients who receive treatment should be informed of the possibility of increased pigmentation.

Beyond 5 years the effects of increased pigmentation are not known. Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish.

Neither nevi nor freckles of the iris appear to be affected by treatment. While treatment with ROCKLATAN can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly [see Patient Counseling Information ( 17 ) ].

5.3Eyelash Changes ROCKLATAN contains latanoprost which may gradually change eyelashes and vellus hair in the treated eye; these changes include increased length, thickness, pigmentation, the number of lashes or hairs, and misdirected growth of eyelashes. Eyelash changes are usually reversible upon discontinuation of treatment [see Patient Counseling Information ( 17 ) ].

5.4Intraocular Inflammation ROCKLATAN contains latanoprost which should be used with caution in patients with a history of intraocular inflammation (iritis/uveitis) and should generally not be used in patients with active intraocular inflammation because it may exacerbate inflammation.

5.5Macular Edema Macular edema, including cystoid macular edema, has been reported during treatment with latanoprost. ROCKLATAN should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.

5.6Herpetic Keratitis Reactivation of Herpes Simplex keratitis has been reported during treatment with latanoprost. ROCKLATAN should be used with caution in patients with a history of herpetic keratitis. ROCKLATAN should be avoided in cases of active herpes simplex keratitis because it may exacerbate inflammation.

5.7Bacterial Keratitis There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface [see Patient Counseling Information ( 17 )].

5.8Use with Contact Lenses Contact lenses should be removed prior to the administration of ROCKLATAN and may be reinserted 15… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~1 min read ▾

6. ADVERSE REACTIONS The most common adverse reaction is conjunctival hyperemia (59%). Other common adverse reactions were: instillation site pain (20%), corneal verticillata (15%), and conjunctival hemorrhage (11%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc. at 1 800 757 9195, 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 clinical practice. The most common ocular adverse reaction observed in controlled clinical studies with ROCKLATAN was conjunctival hyperemia which was reported in 59% of patients. Five percent of patients discontinued therapy due to conjunctival hyperemia.

Other common ocular adverse reactions reported were: instillation site pain (20%), corneal verticillata (15%), and conjunctival hemorrhage (11%). Eye pruritus, visual acuity reduced, increased lacrimation, instillation site discomfort, and blurred vision were reported in 5-8% of patients. Other adverse reactions from clinical trials that have been reported with the individual components and not listed above include: Netarsudil 0.02% Instillation site erythema, corneal staining, increased lacrimation, and erythema of eyelid.

Latanoprost 0.005% Foreign body sensation, punctate keratitis, burning and stinging, itching, increased pigmentation of the iris, excessive tearing, eyelid discomfort, dry eye, eye pain, eyelid margin crusting, erythema of the eyelid, upper respiratory tract infection/nasopharyngitis/influenza, photophobia, eyelid edema, myalgia/arthralgia/back pain, and rash/allergic reactions.

6.2Postmarketing Experience The following adverse reactions have been identified during postmarketing use of ROCKLATAN. 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. Netarsudil 0.02% Eye disorders: Epithelial corneal edema has been reported in some patients with pre-existing corneal stromal edema or ocular procedures that could affect corneal endothelial function. [see Warnings and Precautions ( 5.1 )] .

🔄 Drug Interactions 123 words ▾

7. DRUG INTERACTIONS In vitro drug interaction studies have shown that precipitation can occur when eye drops containing thimerosal are mixed with ROCKLATAN. If such drugs are used, they should be administered at least five (5) minutes apart.

The combined use of two or more prostaglandins or prostaglandin analogs including latanoprost ophthalmic solution 0.005% is not recommended. It has been shown that administration of these prostaglandin drug products more than once daily may decrease the IOP lowering effect or cause paradoxical elevations in IOP. Thimerosal : In vitro studies have shown that precipitation can occur when eye drops containing thimerosal are mixed with ROCKLATAN ® .

If such drugs are used, they should be administered at least 5 minutes apart. ( 7 )

👥 Use in Specific Populations ~2 min read ▾

8. USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies of ROCKLATAN ophthalmic solution or its pharmacologically active ingredients (netarsudil and latanoprost) in pregnant women to inform any drug associated risk. However, systemic exposure to netarsudil from ocular administration is low [see Clinical Pharmacology ( 12.3 ) ]. Reproduction studies of latanoprost showed embryofetal lethality in rabbits.

No embryofetal lethality was observed at a dose approximately 15 times higher than the recommended human ophthalmic dose (RHOD). Intravenous administration of netarsudil to pregnant rats and rabbits during organogenesis did not produce adverse embryofetal effects at clinically relevant systemic exposures. ROCKLATAN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Data Animal Data Netarsudil administered daily by intravenous injection to rats during organogenesis caused abortions and embryofetal lethality at doses ≥0.3 mg/kg/day (126-fold the plasma exposure at the RHOD, based on C max ). The no-observed-adverse-effect-level (NOAEL) for embryofetal development toxicity was 0.1 mg/kg/day (40-fold the plasma exposure at the RHOD, based on C max ). Netarsudil administered daily by intravenous injection to rabbits during organogenesis caused embryofetal lethality and decreased fetal weight at 5 mg/kg/day (1480-fold the plasma exposure at the RHOD, based on C max ).

Malformations were observed at ≥3 mg/kg/day (1330-fold the plasma exposure at the RHOD, based on C max ), including thoracogastroschisis, umbilical hernia and absent intermediate lung lobe. The NOAEL for embryofetal development toxicity was 0.5 mg/kg/day (214-fold the plasma exposure at the RHOD, based on C max ). Reproduction studies have been performed with latanoprost in rats and rabbits.

In 4 of 16 pregnant rabbits, no viable fetuses were present at a dose that was approximately 80 times higher than the RHOD. Latanoprost did not produce embryofetal lethality in rabbits at a dose approximately 15 times higher than the RHOD.

8.2Lactation Risk Summary There are no data on the presence of netarsudil or latanoprost in human milk, the effects on the breastfed infant, or the effects on milk production. However, systemic exposure to netarsudil following topical ocular administration is low, and it is not known whether measurable levels of netarsudil would be present in maternal milk following topical ocular administration. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ROCKLATAN and any potential adverse effects on the breast-fed child from ROCKLATAN.

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

8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies of ROCKLATAN ophthalmic solution or its pharmacologically active ingredients (netarsudil and latanoprost) in pregnant women to inform any drug associated risk. However, systemic exposure to netarsudil from ocular administration is low [see Clinical Pharmacology ( 12.3 ) ]. Reproduction studies of latanoprost showed embryofetal lethality in rabbits.

No embryofetal lethality was observed at a dose approximately 15 times higher than the recommended human ophthalmic dose (RHOD). Intravenous administration of netarsudil to pregnant rats and rabbits during organogenesis did not produce adverse embryofetal effects at clinically relevant systemic exposures. ROCKLATAN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Data Animal Data Netarsudil administered daily by intravenous injection to rats during organogenesis caused abortions and embryofetal lethality at doses ≥0.3 mg/kg/day (126-fold the plasma exposure at the RHOD, based on C max ). The no-observed-adverse-effect-level (NOAEL) for embryofetal development toxicity was 0.1 mg/kg/day (40-fold the plasma exposure at the RHOD, based on C max ). Netarsudil administered daily by intravenous injection to rabbits during organogenesis caused embryofetal lethality and decreased fetal weight at 5 mg/kg/day (1480-fold the plasma exposure at the RHOD, based on C max ).

Malformations were observed at ≥3 mg/kg/day (1330-fold the plasma exposure at the RHOD, based on C max ), including thoracogastroschisis, umbilical hernia and absent intermediate lung lobe. The NOAEL for embryofetal development toxicity was 0.5 mg/kg/day (214-fold the plasma exposure at the RHOD, based on C max ). Reproduction studies have been performed with latanoprost in rats and rabbits.

In 4 of 16 pregnant rabbits, no viable fetuses were present at a dose that was approximately 80 times higher than the RHOD. Latanoprost did not produce embryofetal lethality in rabbits at a dose approximately 15 times higher than the RHOD.

🧒 Pediatric Use 13 words ▾

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

🧓 Geriatric Use 19 words ▾

8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

🧬 Clinical Pharmacology ~2 min read ▾

12. CLINICAL PHARMACOLOGY

12.1Mechanism of Action ROCKLATAN is comprised of two components: netarsudil and latanoprost. Each of these two components decreases elevated IOP. Elevated IOP represents a major risk factor for glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and glaucomatous visual field loss. ROCKLATAN is believed to reduce IOP by increasing the outflow of aqueous humor.

12.3Pharmacokinetics Absorption The systemic exposures of netarsudil and its active metabolite, AR-13503, were evaluated in 18 healthy subjects after topical ocular administration of netarsudil ophthalmic solution 0.02% once daily (1 drop bilaterally in the morning) for 8 days. There were no quantifiable plasma concentrations of netarsudil (lower limit of quantitation (LLOQ) 0.100 ng/mL) post dose on Day 1 and Day 8. Only 1 plasma concentration at 0.11 ng/mL for the active metabolite was observed for 1 subject on Day 8 at 8 hours post-dose.

Distribution The distribution volume in humans is 0.16 ±

0.02L/kg. Latanoprost is absorbed through the cornea where the isopropyl ester prodrug is hydrolyzed to the acid form to become biologically active. The acid of latanoprost can be measured in aqueous humor during the first 4 hours, and in plasma only during the first hour after local administration.

Metabolism After topical ocular dosing, netarsudil is metabolized by esterases in the eye to an active metabolite, AR-13503. Latanoprost, an isopropyl ester prodrug, is hydrolyzed by esterases in the cornea to the biologically active acid. The active acid of latanoprost reaching the systemic circulation is primarily metabolized by the liver to the 1,2-dinor and 1,2,3,4-tetranor metabolites via fatty acid β-oxidation.

Excretion The elimination of the acid of latanoprost from human plasma is rapid (t ½ = 17 min) after both intravenous and topical administration. Systemic clearance is approximately 7 mL/min/kg. Following hepatic β-oxidation, the metabolites are mainly eliminated via the kidneys.

Approximately 88% and 98% of the administered dose are recovered in the urine after topical and intravenous dosing, respectively.

🧬 Mechanism of Action 64 words ▾

12.1Mechanism of Action ROCKLATAN is comprised of two components: netarsudil and latanoprost. Each of these two components decreases elevated IOP. Elevated IOP represents a major risk factor for glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and glaucomatous visual field loss. ROCKLATAN is believed to reduce IOP by increasing the outflow of aqueous humor.

📦 How Supplied / Storage and Handling 126 words ▾

16. HOW SUPPLIED/STORAGE AND HANDLING ROCKLATAN (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% is supplied sterile in clear low density polyethylene bottles with opaque white polyethylene dropper tips and white polypropylene screw caps. 2.5 mL fill in a 4 mL container - NDC # 70727-529-25 Storage: Protect from light.

Until opened, store at 2°C to 8°C (36°F to 46°F). After opening, the product may be kept at 2°C to 25°C (36°F to 77°F) for up to 6 weeks. If after opening the product is kept refrigerated at 2°C to 8°C (36°F to 46°F), then the product can be used until the expiration date stamped on the bottle.

During shipment, the bottle may be maintained at temperatures up to 40°C (104°F) for a period not exceeding 14 days.

📋 Description ~1 min read ▾

11. DESCRIPTION ROCKLATAN (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% is a fixed dose combination of a Rho kinase inhibitor and a prostaglandin F 2α analogue. The chemical name of netarsudil dimesylate is: (S)-4-(3-amino-1-(isoquinolin-6-yl-amino)-1-oxopropan-2-yl)benzyl 2,4-dimethylbenzoate dimesylate.

Its molecular formula is C 30 H 35 N 3 O 9 S 2 and its chemical structure is: Netarsudil mesylate is a light yellow to white powder that is freely soluble in water, soluble in methanol, sparingly soluble in dimethyl formamide, and practically insoluble in dichloromethane and heptane. The chemical name of latanoprost is: isopropyl-(Z)-7[1R,2R,3R,5S) 3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]-5-heptenoate. Its molecular formula is C 26 H 40 O 5 and its chemical structure is: Latanoprost is a colorless to slightly yellow oil that is very soluble in acetonitrile and freely soluble in acetone, ethanol, ethyl acetate, isopropanol, methanol, and octanol.

It is practically insoluble in water. ROCKLATAN (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% is supplied as a sterile, isotonic, buffered aqueous solution of netarsudil mesylate and latanoprost with a pH of approximately 5 and an osmolality of approximately 295 mOsmol/kg. Each mL of ROCKLATAN contains 0.20 mg of netarsudil (equivalent to 0.28 mg of netarsudil dimesylate) and 0.05 mg latanoprost.

Benzalkonium chloride, 0.02%, is added as a preservative. The inactive ingredients are: boric acid, mannitol, sodium hydroxide to adjust pH, and water for injection. The chemical structure of netarsudil mesylate The chemical structure of latanoprost

💬 Information for Patients ~1 min read ▾

17. PATIENT COUNSELING INFORMATION Potential for Pigmentation Advise patients about the potential for increased brown pigmentation of the iris, which may be permanent. Inform patients about the possibility of eyelid skin darkening, which may be reversible after discontinuation of ROCKLATAN [see Warnings and Precautions ( 5.2 ) ].

Potential for Eyelash Changes Inform patients of the possibility of eyelash and vellus hair changes in the treated eye during treatment with ROCKLATAN. These changes may result in a disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Eyelash changes are usually reversible upon discontinuation of treatment.

Handling the Container Instruct patients to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to minimize contamination of the solution. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions [see Warnings and Precautions ( 5.7 ) ]. When to Seek Physician Advice Advise patients that if they develop an intercurrent ocular condition (e.g., trauma, or infection, or decreased vision with or without eye pain), have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, they should immediately seek their physician’s advice concerning the continued use of ROCKLATAN.

Use with Contact Lenses Advise patients that ROCKLATAN contains benzalkonium chloride, which may be absorbed by soft contact lenses. Contact lenses should be removed prior to instillation of ROCKLATAN and may be reinserted 15 minutes following its administration. Use with Other Ophthalmic Drugs If more than 1 topical ophthalmic drug is being used, the drugs should be administered at least 5 minutes between applications.

Missed Dose Advise patients that if one dose is missed, treatment should continue with the next dose in the evening. © 2024-2025 Alcon Inc. U.S. Pat.: www.alconpatents.com ALCON LABORATORIES, Inc., Fort Worth, Texas 76134 1-800-757-9195 [email protected]

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics Absorption The systemic exposures of netarsudil and its active metabolite, AR-13503, were evaluated in 18 healthy subjects after topical ocular administration of netarsudil ophthalmic solution 0.02% once daily (1 drop bilaterally in the morning) for 8 days. There were no quantifiable plasma concentrations of netarsudil (lower limit of quantitation (LLOQ) 0.100 ng/mL) post dose on Day 1 and Day 8. Only 1 plasma concentration at 0.11 ng/mL for the active metabolite was observed for 1 subject on Day 8 at 8 hours post-dose.

Distribution The distribution volume in humans is 0.16 ±

0.02L/kg. Latanoprost is absorbed through the cornea where the isopropyl ester prodrug is hydrolyzed to the acid form to become biologically active. The acid of latanoprost can be measured in aqueous humor during the first 4 hours, and in plasma only during the first hour after local administration.

Metabolism After topical ocular dosing, netarsudil is metabolized by esterases in the eye to an active metabolite, AR-13503. Latanoprost, an isopropyl ester prodrug, is hydrolyzed by esterases in the cornea to the biologically active acid. The active acid of latanoprost reaching the systemic circulation is primarily metabolized by the liver to the 1,2-dinor and 1,2,3,4-tetranor metabolites via fatty acid β-oxidation.

Excretion The elimination of the acid of latanoprost from human plasma is rapid (t ½ = 17 min) after both intravenous and topical administration. Systemic clearance is approximately 7 mL/min/kg. Following hepatic β-oxidation, the metabolites are mainly eliminated via the kidneys.

Approximately 88% and 98% of the administered dose are recovered in the urine after topical and intravenous dosing, respectively.

🔬 Clinical Studies ~2 min read ▾

14. CLINICAL STUDIES ROCKLATAN (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% was evaluated in 2 randomized and controlled clinical trials, namely PG324-CS301 (NCT 02558400, referred to as Study 301) and PG324-CS302 (NCT 02674854, referred to as Study 302) in patients with open-angle glaucoma and ocular hypertension. Studies 301 and 302 enrolled subjects with IOP < 36 mmHg and compared IOP lowering effect of ROCKLATAN dosed once daily to individually administered netarsudil 0.02% once daily and latanoprost 0.005% once daily.

The treatment duration was 12 months for Study 301 and 3 months for Study 302. The average IOP lowering effect of ROCKLATAN was 1 to 3 mmHg greater than monotherapy with either netarsudil 0.02% or latanoprost 0.005% throughout 3 months (Figures 1 and 2). In Study 301 IOP reductions were maintained throughout 12 months.

Figure 1: Study 301 Mean IOP (mmHg) by Treatment Group and Treatment Difference in Mean IOP Rocklatan vs. Netarsudil 95% CI 3.0 (2.5, 3.6) 3.0 (2.4, 3.6) 2.4 (1.9, 3.0) 3.2 (2.6, 3.8) 2.9 (2.3, 3.5) 2.3 (1.7, 2.8) 3.1 (2.5, 3.8) 3.2 (2.5, 3.8) 2.0 (1.4, 2.6) Rocklatan vs. Latanoprost 95% CI 2.3 (1.7, 2.8) 2.6 (2.0, 3.2) 2.3 (1.8, 2.9) 1.7 (1.1, 2.4) 1.9 (1.3, 2.5) 1.7 (1.1, 2.2) 1.5 (0.9, 2.1) 1.7 (1.1, 2.3) 1.3 (0.7, 1.9) The least square mean IOP at each post-baseline time point was derived using an analysis of covariance adjusted for baseline IOP and based on observed data for all randomized subjects (238 in Rocklatan group, 244 in netarsudil group, 236 in latanoprost group).

Figure 2: Study 302 Mean IOP (mmHg) by Treatment Group and Treatment Difference in Mean IOP Rocklatan vs. Netarsudil 95% CI 3.4 (2.8, 3.9) 2.7 (2.2, 3.2) 2.2 (1.7, 2.8) 3.2 (2.6, 3.8) 2.9 (2.3, 3.4) 2.3 (1.8, 2.9) 3.6 (3.0, 4.2) 2.8 (2.3, 3.4) 2.4 (1.9, 2.9) Rocklatan vs. Latanoprost 95% CI 2.0 (1.5, 2.6) 2.4 (1.9, 2.9) 1.9 (1.3, 2.4) 1.5 (0.9, 2.1) 1.9 (1.3, 2.4) 1.6 (1.0, 2.1) 1.5 (0.9, 2.2) 2.0 (1.4, 2.5) 1.5 (1.0, 2.1) The least square mean IOP at each post-baseline time point was derived using an analysis of covariance adjusted for baseline IOP and based on observed data for all randomized subjects (245 in Rocklatan group, 255 in netarsudil group, 250 in latanoprost group).

Figure 1 Figure 2

🧪 Nonclinical Toxicology 156 words ▾

13. NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term studies in animals have not been performed to evaluate the carcinogenic potential of netarsudil. Latanoprost was not carcinogenic in either mice or rats when administered by oral gavage at doses of up to 170 mcg/kg/day (approximately 2800 times the RHOD) for up to 20 and 24 months, respectively. Mutagenesis Netarsudil was not mutagenic in the Ames test, in the mouse lymphoma test, or in the in vivo rat micronucleus test.

Latanoprost was not mutagenic in bacteria, in mouse lymphoma, or in mouse micronucleus tests. Chromosome aberrations were observed in vitro with human lymphocytes. Additional in vitro and in vivo studies on unscheduled DNA synthesis in rats were negative.

Impairment of Fertility Studies to evaluate the effects of netarsudil on male or female fertility in animals have not been performed. Latanoprost has not been found to have effects on male or female fertility in animal studies.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 153 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term studies in animals have not been performed to evaluate the carcinogenic potential of netarsudil. Latanoprost was not carcinogenic in either mice or rats when administered by oral gavage at doses of up to 170 mcg/kg/day (approximately 2800 times the RHOD) for up to 20 and 24 months, respectively. Mutagenesis Netarsudil was not mutagenic in the Ames test, in the mouse lymphoma test, or in the in vivo rat micronucleus test.

Latanoprost was not mutagenic in bacteria, in mouse lymphoma, or in mouse micronucleus tests. Chromosome aberrations were observed in vitro with human lymphocytes. Additional in vitro and in vivo studies on unscheduled DNA synthesis in rats were negative.

Impairment of Fertility Studies to evaluate the effects of netarsudil on male or female fertility in animals have not been performed. Latanoprost has not been found to have effects on male or female fertility in animal studies.

📄 Recent Major Changes 10 words ▾

Warnings and Precautions, Epithelial Corneal Edema ( 5.1 ) 01/2025

📄 Package Label / Principal Display Panel ~2 min read ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 70727-529-25 rocklatan ® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% For topical application in the eye Sterile Rx only 2.5 mL Alcon Usual dosage: One drop in the affected eye(s) once daily in the evening. Each ml Rocklatan ® ophthalmic solution contains: Active: netrasudil mesylate 0.285 mg latanoprost 0.050 mg Preservative: benzalkonium chloride 0.20 mg Inactives: mannitol, boric acid, sodium hydroxide to adjust pH and water for injection. ALCON LABORATORIES, INC.

Fort Worth, TX 76134 USA U.S. Pat.: www.alconpatents.com PROTECT FROM LIGHT Until opened, store at 2°C - 8°C (36°F - 46°F). After opening, the product may be kept at 2°C - 25°C (36°F - 77°F) for up to 6 weeks.

If after opening the product is kept refrigerated at 2°C - 8°C (36°F - 46°F), then the product can be used until the expiration date stamped on the bottle. During shipment, the bottle may be maintained at temperatures up to 40°C (104°F) for a period not exceeding 14 days. 300068395-1224 SN: LOT: EXP.

GTIN: 00370727529253 PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 70727-529-25 For topical application in the eye. rocklatan ® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% Sterile 2.5 mL Rx only Alcon See carton for storage conditions. Alcon Laboratories, Inc. Fort Worth, TX 76134 USA 300068406 1224 PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 70727-529-99 SAMPLE – Not for Resale rocklatan ® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% For topical application in the eye Sterile Rx only 2.5 mL Usual dosage: One drop in the affected eye(s) once daily in the evening.

Each ml Rocklatan ® ophthalmic solution contains: Active: netrasudil mesylate 0.285 mg latanoprost 0.050 mg Preservative: benzalkonium chloride 0.20 mg Inactives: mannitol, boric acid, sodium hydroxide to adjust pH and water for injection. ALCON LABORATORIES, INC. Fort Worth, TX 76134 USA U.S.

Pat.: www.alconpatents.com PROTECT FROM LIGHT Until opened, store at 2°C - 8°C (36°F - 46°F). After opening, the product may be kept at 2°C - 25°C (36°F - 77°F) for up to 6 weeks. If after opening the product is kept refrigerated at 2°C - 8°C (36°F - 46°F), then the product can be used until the expiration date stamped on the bottle.

During shipment, the bottle may be maintained at temperatures up to 40°C (104°F) for a period not exceeding 14 days. 300068396-1124 PACKAGE/LABEL PRINCIPAL DISPLAY NDC 70727-529-99 SAMPLE – Not for Resale rocklatan ® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% Sterile 2.5 mL Rx only Alcon For topical application in the eye. See carton for storage conditions.

Alcon Laboratories, Inc. Fort Worth, TX 76134 USA LOT: EXP.: 300068407 1124

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

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 bottle70727-0529-25 26,087 Rx · $10,657,656
1 bottle this page70727-0529-99 No Medicaid data
Drug total (last 4 qtrs): 26,087 Rx · 76,439 units · $10,657,656 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 Rocklatan — 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 Rocklatan. 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
$41.95M
Claims incl. refills
79.1K
Beneficiaries
48K
Spend / beneficiary
$873.45
Spend / claim
$530.10
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.

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 — 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.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Alcon Laboratories, Inc.. 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 bottle (70727-0529-25). 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?
Alcon Laboratories, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.
← 70727-0497-25 · Alcon 70729-0001-24 · Breeden →
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.