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Ryzumvi phentolamine mesylate 10 mg/mL Solution/ Drops — NDC 83368-0075-31 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ryzumvi phentolamine mesylate 10 mg/mL Solution/ Drops — NDC 83368-075-31 (Billing 83368-0075-31)

by Oyster Point Pharma, Inc. · 1 POUCH in 1 CARTON / 5 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE

This is a package of Ryzumvi phentolamine mesylate 10 mg/mL Solution/ Drops from Oyster Point Pharma, Inc., marketed since Mar 2024 and currently FDA-listed.

NDC 83368-0075-31
🏷️ FDA NDC (as labeled) 83368-075-31 billing pads the product segment with a zero
This package
Contains.2 mL in 1 vial, single-use Pack sizes2 compare ↓
Product page 83368-0075-30 Also comes in: 6 pouches 83368-075-30
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 83368-075-31 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
83368 labeler · 075 product · 31 package
Package marketed since
Sep 25, 2024
Sample package
Yes — professional sample, not for sale
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8336807531 7
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Phentolamine Mesylate (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 31, 2025 — Defective container: cracked/broken cartridges (Novocol Pharmaceutical of Canada, Inc.) · FDA recall D-0234-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 83368-075-31
Product NDC 83368-075
11-digit billing NDC 83368007531
RxCUI 2677793, 2677798
UNII Y7543E5K9T
Application # NDA217064
SPL Set ID 96bb1e53-c2cc-4e60-a21a-db0269c371bf
Established class (EPC) alpha-Adrenergic Blocker
Mechanism of action Adrenergic alpha-Antagonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-03-25
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance PHENTOLAMINE MESYLATE

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

GCN Seq No 086708
GCN 56455
HICL code 049978
Ingredient (HICL) Phentolamine Mesylate/Pf
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6A
Therapeutic class — specific (HIC3) Ophthalmic Preparations, Miscellaneous
AHFS code 52:92.00.00
AHFS class Eent Drugs, Miscellaneous
FDB label name RYZUMVI 0.75% EYE DROP
FDB brand name Ryzumvi
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 086708
  • GCN: 56455
  • HICL (First Databank): 049978
  • AHFS class code: 52:92.00.00
  • RxCUI (RxNorm): 2677793
Why two NDCs? The FDA registers this code as 83368-075-31 — 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 → 83368-0075-31. 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 alpha-Adrenergic Blocker class.

Pharmacologic class alpha-Adrenergic Blocker
Drug family (ATC) Imidazoline derivatives, Antidotes
How it works Adrenergic alpha-Antagonists
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 RYZUMVI 0.75% EYE DROP Ingredient Phentolamine Mesylate/Pf

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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 6 pouches
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 Marketing startMarketing endStatus
83368-0075-30 83368-075-30 Main listing 6 POUCH in 1 CARTON / 5 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE 2024-03-25 — Active
83368-0075-31 You're viewing this 1 POUCH in 1 CARTON / 5 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE Sample 2024-09-25 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 pouch in 1 carton / 5 vial, single-use in 1 pouch / .2 ml in 1 vial, single-use.
What NDC number is used to bill for this package of Ryzumvi phentolamine mesylate 10 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ryzumvi 10 mg/mLthis 83368-0075-31 Oyster 1 pouch — — 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

🏛️
2023
First FDA approval
Sep 2023
📍
2026
Currently FDA-listed
3 years listed
🛡️
2039
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 Oct 2039. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Sep 25, 2023 RLD RS ⏳ ~13 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 12201616 — method of use (U-3804)
US 12201615 — method of use (U-3804)
US 11400077 — method of use (U-3804)
US 12576067 — method of use (U-3804)
US 12576066 — method of use (U-3804)
US 12350366 — drug product
US 11844858 — drug product
US 9795560 — drug product
US 11090261 — drug product
US 10278918 — drug product
US 10772829 — drug product
Exclusivity NP
2023 2025 2027 2029 2031 2033 2035 2037 2039
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (11)
PatentTypeUse codeExpires
US 12201616 ↗ Method of use U-3804 Oct 25, 2039
US 12201615 ↗ Method of use U-3804 Oct 25, 2039
US 11400077 ↗ Method of use U-3804 Oct 25, 2039
US 12576067 ↗ Method of use U-3804 Oct 25, 2039
US 12576066 ↗ Method of use U-3804 Oct 25, 2039
US 12350366 ↗ Drug product — Jan 31, 2034
US 11844858 ↗ Drug product — Jan 31, 2034
US 9795560 ↗ Drug product — Jan 31, 2034
US 11090261 ↗ Drug product — Jan 31, 2034
US 10278918 ↗ Drug product — Jan 31, 2034
US 10772829 ↗ Drug product — Jan 31, 2034
FDA exclusivity
CodeWhat it grantsExpires
NPNew ProductSep 25, 2026
Common questions
Is there a generic version of RYZUMVI 0.75% EYE DROP?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for RYZUMVI 0.75% EYE DROP. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Oct 2039 — 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 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 4550K0SC9B
    Sodium acetate is a salt derived from acetic acid. It acts as a buffer to help maintain the medicine's pH stability and may serve as a preservative or solubilizer in liquid formulations.
  • UNII 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.

3 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

LabelerOyster Point Pharma, Inc.
Application holderFAMYGEN LIFE SCIENCES INC
FDA applicationNDA217064 (NDA)
Labeler code83368
First marketedMar 2024
Product typeHuman Prescription Drug
Portfolio2 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. 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 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 50 words ▾

1 INDICATIONS AND USAGE RYZUMVI is indicated for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic agents (e.g., tropicamide). RYZUMVI is an alpha-adrenergic blocker indicated for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic agents (e.g., tropicamide). ( 1 )

⏱️ Dosage and Administration 153 words ▾

2 DOSAGE AND ADMINISTRATION Adults and Pediatric Patients Aged 12 Years or Older: Instill 1 or 2 drops in each dilated eye following the completion of the ophthalmic examination or procedure. If 2 drops are instilled, the second drop should be administered 5 minutes after the first drop. Pediatric Patients Aged 3 to 11 Years: Instill 1 drop in each dilated eye following the completion of the ophthalmic examination or procedure.

One single-patient-use vial can be used to dose each dilated eye. Discard the single-patient-use vial immediately after use. • Adults and Pediatric Patients Aged 12 Years and Older: Instill 1 to 2 drops in each dilated eye following the completion of the ophthalmic examination or procedure to reverse mydriasis. ( 2 ) • Pediatric Patients Aged 3 to 11 Years: Instill 1 drop in each dilated eye following the completion of the ophthalmic examination or procedure to reverse mydriasis.

( 2 )

💊 Dosage Forms and Strengths 29 words ▾

3 DOSAGE FORMS AND STRENGTHS Ophthalmic solution: clear and colorless solution containing phentolamine 0.75% in a single-patient-use vial. Ophthalmic solution: phentolamine 0.75% in a single-patient-use vial. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions 113 words ▾

5 WARNINGS AND PRECAUTIONS Uveitis : RYZUMVI is not recommended to be used in patients with active ocular inflammation. ( 5.1 )

5.1Uveitis RYZUMVI is not recommended when active ocular inflammation (e.g., iritis) is present because adhesions (synechiae) may form between the iris and the lens.

5.2Potential for Eye Injury or Contamination To avoid the potential for eye injury or contamination, care should be taken to avoid touching the vial tip to the eye or to any other surface.

5.3Use with Contact Lenses Contact lens wearers should be advised to remove their lenses prior to the instillation of RYZUMVI and wait 10 minutes after dosing before reinserting their contact lenses.

🤒 Adverse Reactions 141 words ▾

6 ADVERSE REACTIONS The most common adverse reactions that have been reported are instillation site discomfort (16%), conjunctival hyperemia (12%), and dysgeusia (6%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) 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. RYZUMVI was evaluated in 642 subjects in clinical trials across various subject populations. The most common ocular adverse reactions reported in > 5% of subjects were instillation site discomfort including pain, stinging, and burning (16%) and conjunctival hyperemia (12%).

The only non-ocular adverse reaction reported in > 5% of subjects was dysgeusia (6%).

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available data with RYZUMVI administration in pregnant women to inform a drug-associated risk. In animal toxicology studies, when phentolamine was administered orally to pregnant mice and rats during the period of organogenesis, skeletal immaturity and decreased growth was observed in the offspring at doses at least 24-times the recommended clinical dose. Additionally, a lower rate of implantation was seen in pregnant rats treated with phentolamine administered at least 60-times the recommended clinical dose.

No malformations or embryofetal deaths were observed in the offspring of pregnant mice, rats, and rabbits administered phentolamine during the period of organogenesis at doses of at least 24-, 60-, and 20-times, respectively, the recommended clinical dose (see Data ) . RYZUMVI should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. Data Animal Data Oral administration of phentolamine to pregnant rats and mice at doses at least 24-times the recommended clinical dose (based on a body weight per surface area (mg/m 2 ) comparison with a 60-kg human) resulted in slightly decreased growth and slight skeletal immaturity of the fetuses.

Immaturity was manifested by increased incidence of incomplete or unossified calcanei and phalangeal nuclei of the hind limb and of incompletely ossified sternebrae. At oral phentolamine doses at least 60-times the recommended clinical dose (based on a mg/m 2 comparison with a 60-kg human), a slightly lower rate of implantation was found in rats. Phentolamine did not affect embryonic or fetal development in rabbits at oral doses at least 20-times the recommended dose (based on a mg/m 2 comparison with a 60-kg human).

No malformations or embryofetal deaths were observed in the rat, mouse or rabbit studies.

8.2Lactation Risk Summary There is no information regarding the presence of phentolamine in human milk, the effects on the breastfed infants, or the effects on milk production during lactation to inform risk of phentolamine ophthalmic solution 0.75% to an infant. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for RYZUMVI and any potential adverse effects on the breastfed child from RYZUMVI.

8.4Pediatric Use The safety and effectiveness of RYZUMVI have been established in pediatric patients aged 3 to 17 years. No overall differences have been observed between pediatric and adult subjects [see Clinical Studies (14) ] .

8.5Geriatric Use No overall differences in safety and effectiveness have been observed between elderly and younger adult subjects.

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary There are no available data with RYZUMVI administration in pregnant women to inform a drug-associated risk. In animal toxicology studies, when phentolamine was administered orally to pregnant mice and rats during the period of organogenesis, skeletal immaturity and decreased growth was observed in the offspring at doses at least 24-times the recommended clinical dose. Additionally, a lower rate of implantation was seen in pregnant rats treated with phentolamine administered at least 60-times the recommended clinical dose.

No malformations or embryofetal deaths were observed in the offspring of pregnant mice, rats, and rabbits administered phentolamine during the period of organogenesis at doses of at least 24-, 60-, and 20-times, respectively, the recommended clinical dose (see Data ) . RYZUMVI should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. Data Animal Data Oral administration of phentolamine to pregnant rats and mice at doses at least 24-times the recommended clinical dose (based on a body weight per surface area (mg/m 2 ) comparison with a 60-kg human) resulted in slightly decreased growth and slight skeletal immaturity of the fetuses.

Immaturity was manifested by increased incidence of incomplete or unossified calcanei and phalangeal nuclei of the hind limb and of incompletely ossified sternebrae. At oral phentolamine doses at least 60-times the recommended clinical dose (based on a mg/m 2 comparison with a 60-kg human), a slightly lower rate of implantation was found in rats. Phentolamine did not affect embryonic or fetal development in rabbits at oral doses at least 20-times the recommended dose (based on a mg/m 2 comparison with a 60-kg human).

No malformations or embryofetal deaths were observed in the rat, mouse or rabbit studies.

🧒 Pediatric Use 37 words ▾

8.4Pediatric Use The safety and effectiveness of RYZUMVI have been established in pediatric patients aged 3 to 17 years. No overall differences have been observed between pediatric and adult subjects [see Clinical Studies (14) ] .

🧓 Geriatric Use 19 words ▾

8.5Geriatric Use No overall differences in safety and effectiveness have been observed between elderly and younger adult subjects.

🆘 Overdosage 78 words ▾

10 OVERDOSAGE No deaths due to acute poisoning with phentolamine have been reported. Overdosage with parenterally administered phentolamine is characterized chiefly by cardiovascular disturbances, such as arrhythmias, tachycardia, hypotension, and possibly shock. In addition, the following might occur: excitation, headache, sweating, visual disturbances, nausea, vomiting, diarrhea, or hypoglycemia.

There is no specific antidote; treatment consists of appropriate monitoring and supportive care. Substantial decreases in blood pressure or other evidence of shock-like conditions should be treated vigorously and promptly.

🧬 Clinical Pharmacology 168 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action RYZUMVI is a relatively non-selective alpha-1 and alpha-2 adrenergic antagonist. Dilation of the pupil is primarily controlled by the radial iris dilator muscles surrounding the pupil; these muscles are activated by the alpha-1 adrenergic receptors. Phentolamine reversibly binds to these receptors on the iris dilator muscle, thereby reducing pupil diameter.

Phentolamine directly antagonizes the mydriatic effect of an α-1 adrenergic agonist, and indirectly reverses mydriasis induced by muscarinic antagonist effects on the iris sphincter muscle.

12.2Pharmacodynamics The onset of action after administration of RYZUMVI generally occurs in 30 minutes, with the maximal effect seen in 60 to 90 minutes, and the effect lasting at least 24 hours.

12.3Pharmacokinetics Phentolamine systemic exposure was evaluated in a Phase 3 trial (MIRA-3) following topical ocular administration of a total of 3 drops, each of 0.03 mL, of phentolamine ophthalmic solution 0.75%. The peak concentration levels are achieved between 15 minutes and 1 hour after dosing with the median value of 0.45 ng/mL.

🧬 Mechanism of Action 79 words ▾

12.1Mechanism of Action RYZUMVI is a relatively non-selective alpha-1 and alpha-2 adrenergic antagonist. Dilation of the pupil is primarily controlled by the radial iris dilator muscles surrounding the pupil; these muscles are activated by the alpha-1 adrenergic receptors. Phentolamine reversibly binds to these receptors on the iris dilator muscle, thereby reducing pupil diameter.

Phentolamine directly antagonizes the mydriatic effect of an α-1 adrenergic agonist, and indirectly reverses mydriasis induced by muscarinic antagonist effects on the iris sphincter muscle.

📦 How Supplied / Storage and Handling 220 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING RYZUMVI (phentolamine ophthalmic solution) 0.75% is supplied as a sterile, clear, and colorless solution for topical ophthalmic use contained in a translucent, low-density polyethylene, single-patient-use vial with a 0.2 mL fill. One strip of 5 single-patient-use vials is packaged into a foil pouch, with 5 or 6 foil pouches in a carton. One single-patient-use vial should be dispensed for each patient, and it can be used to dose both eyes.

Carton of 25 single-patient-use vials – NDC-83368-075-32 Carton of 30 single-patient-use vials – NDC-83368-075-30 Storage and Handling: Store refrigerated at 2°C to 8°C (36°F to 46°F) in original packaging, not to exceed the expiration date printed on the carton and pouch. Protect from freezing. If the carton or pouch is removed from refrigeration, RYZUMVI may be stored at room temperature [up to 25°C (77°F)] but must be used within 35 days, not to exceed the expiration date printed on the vial.

The vial once opened should be discarded immediately after use. Unused vials should remain in the opened foil pouch until ready for use. © 2025 Viatris Inc. RYZUMVI is a registered trademark of Opus Genetics, Inc., licensed to the Viatris Companies.

The brands listed are trademarks of their respective owners. Distributed by: Oyster Point Pharma, Inc., a Viatris Company Morgantown, WV 26505 U.S.A. OYP:RZMVI:RX

📋 Description 137 words ▾

11 DESCRIPTION RYZUMVI (phentolamine ophthalmic solution) 0.75% is a sterile, clear and colorless solution for topical ophthalmic use containing 1% phentolamine mesylate (equivalent to 0.75% phentolamine). The product does not contain an anti-microbial preservative. The chemical name of phentolamine mesylate is 3-[[(4,5-dihydro-1H-imidazol-2-yl)methyl](4-methylphenyl)amino]phenol; methanesulfonic acid (parent phentolamine: [3-[[(4,5-dihydro-1H-imidazol-2-yl)methyl](4-methylphenyl)amino]phenol]) and the molecular formula is C 18 H 23 N 3 O 4 S (parent C 17 H 19 N 3 O).

The molecular weight of phentolamine mesylate is 377.46 and the chemical structure is: Each mL of RYZUMVI contains phentolamine mesylate 10 mg as the active ingredient (equivalent to 7.5 mg phentolamine as the free base). Inactive ingredients are mannitol, sodium acetate trihydrate, and water for injection. Hydrochloric acid and/or sodium hydroxide are added to adjust pH (4.5 to 5.5), and the solution is overlaid with nitrogen. chemical structure

🧬 Pharmacokinetics 53 words ▾

12.3Pharmacokinetics Phentolamine systemic exposure was evaluated in a Phase 3 trial (MIRA-3) following topical ocular administration of a total of 3 drops, each of 0.03 mL, of phentolamine ophthalmic solution 0.75%. The peak concentration levels are achieved between 15 minutes and 1 hour after dosing with the median value of 0.45 ng/mL.

🧬 Pharmacodynamics 33 words ▾

12.2Pharmacodynamics The onset of action after administration of RYZUMVI generally occurs in 30 minutes, with the maximal effect seen in 60 to 90 minutes, and the effect lasting at least 24 hours.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES The efficacy of RYZUMVI for the reversal of mydriasis was demonstrated in two, randomized, double-masked, vehicle-controlled trials; MIRA-2 (NCT#04620213) and MIRA-3 (NCT#05134974). A total of 553 subjects, aged 12 to 80 years, who had mydriasis induced by instillation of phenylephrine or tropicamide or a combination of hydroxyamphetamine hydrobromide and tropicamide (Paremyd ® ) were randomized. Subjects with light and dark irides were included in both trials.

Two drops (study eye) or one drop (fellow eye) of RYZUMVI or placebo (vehicle) were administered one hour after instillation of the mydriatic agent. The percentage of subjects with study eyes returning to ≤ 0.2 mm from baseline pupil diameter was statistically significantly greater (p < 0.01) at all time points measured from 60 minutes through 24 hours in the RYZUMVI group compared with the placebo (vehicle) group across both of the MIRA-2 and MIRA-3 trials (see Figure 1). Figure 1.

Percentage of Subjects with Study Eyes Returning to ≤ 0.2 mm from Baseline Pupil Diameter by Time Point in the MIRA-2 and MIRA-3 Trials The efficacy of MIRA-2 and MIRA-3 also showed that the change from maximum pupil dilation in study eyes and fellow eyes was statistically significantly different between the RYZUMVI-treated group and the placebo-treated group at all time points from 60 minutes through 24 hours post-treatment (p < 0.01). Pupil size at 24 hours was 1 mm smaller than baseline. These results were consistent regardless of whether phenylephrine or tropicamide/Paremyd were used as mydriatic agents (Figure 2, Figure 3; respectively).

Figure 2: Pupil Dilation by Time Point with Phenylephrine as Mydriatic Agent in MIRA-2 and MIRA-3 Trials (mITT Population) Figure 3: Pupil Dilation by Time Point with Tropicamide or Paremyd as Mydriatic Agent in MIRA-2 and MIRA-3 Trials (mITT Population) The efficacy of RYZUMVI was similar for all age ranges including pediatric subjects aged 3 to 17 years. Pediatric subjects aged 12 to 17 years (n = 27) were treated in MIRA-2 and MIRA-3 and pediatric subjects, aged 3 to 11 years (n = 11) were treated in MIRA-4, (NCT#05223478).

Figure 1 Figure 2 Figure 3

🧪 Nonclinical Toxicology 183 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity studies with RYZUMVI have not been conducted. Mutagenesis Phentolamine was not mutagenic in the in vitro bacterial reverse mutation (Ames) assay. In the in vitro chromosomal aberration study in Chinese hamster ovary cells, numerical aberrations were slightly increased after a 4-hour exposure to phentolamine without metabolic activation, and structural aberrations were slightly increased after a 4-hour exposure to phentolamine with metabolic activation only at the highest concentrations tested, but neither numerical nor structural aberrations were increased after a 20-hour exposure without metabolic activation.

Phentolamine was not clastogenic in two in vivo mouse micronucleus assays. Impairment of Fertility The effect of phentolamine on female fertility has not been studied. Male rats treated with oral phentolamine for 9 weeks (4 weeks prior to mating, 3 weeks during the mating period and 2 weeks after mating) were mated with untreated females.

At doses up to 648-times human therapeutic exposure levels at the Cmax, no adverse effects on male fertility parameters or on reproductive parameters in the untreated females mated with the treated males were observed.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 180 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity studies with RYZUMVI have not been conducted. Mutagenesis Phentolamine was not mutagenic in the in vitro bacterial reverse mutation (Ames) assay. In the in vitro chromosomal aberration study in Chinese hamster ovary cells, numerical aberrations were slightly increased after a 4-hour exposure to phentolamine without metabolic activation, and structural aberrations were slightly increased after a 4-hour exposure to phentolamine with metabolic activation only at the highest concentrations tested, but neither numerical nor structural aberrations were increased after a 20-hour exposure without metabolic activation.

Phentolamine was not clastogenic in two in vivo mouse micronucleus assays. Impairment of Fertility The effect of phentolamine on female fertility has not been studied. Male rats treated with oral phentolamine for 9 weeks (4 weeks prior to mating, 3 weeks during the mating period and 2 weeks after mating) were mated with untreated females.

At doses up to 648-times human therapeutic exposure levels at the Cmax, no adverse effects on male fertility parameters or on reproductive parameters in the untreated females mated with the treated males were observed.

📄 Package Label / Principal Display Panel 211 words ▾

PRINCIPAL DISPLAY PANEL – 0.75% NDC: 83368-075-30 Rx Only Ryzumvi ® (phentolamine ophthalmic solution) 0.75% FOR TOPICAL USE IN THE EYES Sterile Contents: 30 single-patient-use vials (6 pouches containing 5 single-patient-use vials each) Dosage: See Prescribing Information. Active: Each mL contains phentolamine mesylate 10 mg (equivalent to 7.5 mg phentolamine as the free base); Inactives: mannitol, sodium acetate trihydrate, and water for injection. May contain either hydrochloric acid or sodium hydroxide to adjust pH.

Storage: Store refrigerated at 2°C to 8°C (36°F to 46°F) in original packaging, not to exceed the expiration date printed on the carton and pouch. Protect from freezing. If the carton or pouch is removed from refrigeration, RYZUMVI may be stored at room temperature [up to 25℃ (77°F)] but must be used within 35 days, not to exceed the expiration date printed on the vial.

The vial once opened should be discarded immediately after use. Unused vials should remain in the opened foil pouch until ready for use. Does not contain an anti-microbial preservative.

OYP:075:6C:R3 Distributed by: Oyster Point Pharma, Inc., a Viatris Company Morgantown, WV 26505 U.S.A. © 2025 Viatris Inc. RYZUMVI is a registered trademark and the Ryzumvi Logo is a trademark of Opus Genetics, Inc., licensed to the Viatris Companies. Ryzumvi 0.75% Container Label

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

About this NDC listing & data coverage

Finished prescription product
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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
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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 Oyster Point Pharma, 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 6 pouches (83368-0075-30). 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?
Oyster Point Pharma, 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.
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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.