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VISIONBLUE Trypan Blue .3 mg/.5mL Injection, Solution, 10 pouches — NDC 68803-0612-10 package photo

VISIONBLUE Trypan Blue .3 mg/.5mL Injection, Solution, 10 pouches

by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · 10 POUCH in 1 CARTON (68803-612-10) / 1 SYRINGE, GLASS in 1 POUCH / .5 mL in 1 SYRINGE, GLASS
NDC 68803-0612-10
🏷️ FDA NDC (as labeled) 68803-612-10 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 68803-612-10
Product NDC 68803-612
11-digit billing NDC 68803061210
NCPDP billing unit ML — per mL (volume)
UNII I2ZWO3LS3M
Application # NDA021670
SPL Set ID a44bc2ef-3d7f-4125-a7f7-c5969b1b4142
Established class (EPC) Diagnostic Dye
Mechanism of action Dyes
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2004-12-16
Route INTRAOCULAR, OPHTHALMIC
Dosage form INJECTION, SOLUTION
Substance TRYPAN BLUE
GPI-14 86780085102020
GPI class VisionBlue
GCN Seq No 059774
GCN 25583
HICL code 033233
Ingredient (HICL) Trypan Blue
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q2
Therapeutic class — intermediate (HIC2) Drugs Acting On The Eye
HIC3 code Q2B
Therapeutic class — specific (HIC3) Ophthalmic Surgical Aids
AHFS code 36:58.00.00
AHFS class Ocular Disorders
FDB label name VISIONBLUE 0.06% SYRINGE
FDB brand name Visionblue
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 68803-612-10 — 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 → 68803-0612-10. 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.

🏭 Manufacturer & labeler

LabelerD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Application holderDORC INTERNATIONAL BV
FDA applicationNDA021670 (NDA)
Labeler code68803
First marketedDec 2004
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.

🩺 Clinical

Label name VISIONBLUE 0.06% SYRINGE Ingredient Trypan Blue
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.

🧪 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.

  • 4.1 mg / 0.5 mL UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • 0.85 mg / 0.5 mL UNII 94255I6E2T
    Sodium phosphate dibasic dihydrate is a salt that helps control the acidity level of a medicine. It acts as a buffer and pH regulator to keep the medication stable and effective.
  • 0.15 mg / 0.5 mL UNII 5QWK665956
    A salt derived from phosphoric acid and sodium, used primarily as a buffer to control the acidity or pH of a medication, helping keep it stable during storage and use.
  • 0.5 mL / 0.5 mL 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.

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

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo 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.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Visionblue .3 mg/.5mLthis 68803-0612-10 D.O.R.C. 10 pouches — — 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

🏛️
2004
On the market since
Dec 2004
📍
2026
Currently FDA-listed
22 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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.

🔬 Reported adverse events (FAERS)

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

Top reported reactions

Toxic Anterior Segment Syndrome24
Blindness22
Corneal Oedema10
Product Quality Issue6
Cerebral Infarction3
Endophthalmitis3
Pigmentation Disorder3

Age at onset

Elderly1

Reporter sex

46 reports
Male · 63%
Female · 37%

Serious outcomes

Hospitalization1
Disabling1
Death1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 5 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68803-0612-10 You're viewing this 10 POUCH in 1 CARTON (68803-612-10) / 1 SYRINGE, GLASS in 1 POUCH / .5 mL in 1 SYRINGE, GLASS 2004-12-16 Active

🧭 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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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 FDA registers it as 68803-612-10, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 68803-0612-10, written without dashes as 68803061210. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 68803-0612-10, the first segment (68803) is the labeler code FDA assigned to D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.; the middle segment (0612) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description
🎯 Indications and Usage 46 words ▾

Indications & Usage VisionBlue® 0.06% is indicated for use as an aid in ophthalmic surgery by staining the anterior capsule of the lens. VisionBlue® 0.06% is a diagnostic dye indicated for use as an aid in ophthalmic surgery by staining the anterior capsule of the lens.

⏱️ Dosage and Administration 130 words ▾

Dosage & Administration Cataract surgery. VisionBlue® 0.06% is packaged in a single-patient-use syringe filled to a volume of 0.5 mL syringe to which a blunt cannula has to be attached. After opening the eye, an air bubble is injected into the anterior chamber of the eye in order to minimize dilution of VisionBlue® 0.06% by the aqueous.

VisionBlue® 0.06% is carefully applied onto the anterior lens capsule using a blunt cannula. Sufficient staining is achieved as soon as the dye has contacted the capsule. The anterior chamber is then irrigated with balanced salt solution to remove all excess dye.

An anterior capsulotomy can then be performed. Inject an air bubble into the anterior chamber; Carefully apply VisionBlue® 0.06% onto the lens capsule; Remove all excess dye from the anterior chamber.

💊 Dosage Forms and Strengths 40 words ▾

Dosage forms & Strengths VisionBlue® (trypan blue ophtalmic solution) 0.06% is a clear, dark blue ophtalmic solution supplied in 2.25 mL single-patient-use syringe filled to a volume of 0.5 mL. VisionBlue® (trypan blue ophthalmic solution) 0.06% in a single-patient-use syringe.

⛔ Contraindications 44 words ▾

Contraindications VisionBlue® 0.06% is contraindicated when a non-hydrated (dry state), hydrophilic acrylic intraocular lens (IOL) is planned to be inserted into the eye. The dye may be absorbed by the IOL and stain it. Insertion of a non-hydrated (dry-state), hydrophilic acrylic intraocular lens (IOL).

⚠️ Warnings and Cautions 44 words ▾

Warnings and Precautions Excessive staining : It is recommended that after injection all excess VisionBlue® 0.06% is immediately removed from the eye by thorough irrigation of the anterior chamber. Excessive staining : Excess VisionBlue® 0.06% should be removed from the eye immediately after staining.

🤒 Adverse Reactions 82 words ▾

Adverse Reactions Adverse reactions reported following use of VisionBlue® 0.06% include discoloration of high water content hydrogen intraocular lenses ( see Contraindications ) and inadvertent staining of the posterior lens capsule and vitreous face. Staining of the posterior lens capsule or staining of the vitreous face is generally self limited, lasting up to one week. Inadvertent staining of the posterior lens capsule and vitreous face.

To report SUSPECTED ADVERSE REACTIONS contact, Dutch Ophtalmic, USA at 1-800-75-DUTCH or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

👥 Use in Specific Populations ~2 min read ▾

Use in specific populations Pregnancy Risk Summary There are no available data on the use of VisionBlue® 0.06% in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Systemic absorption of VisionBlue® 0.06% in humans is expected to be negligible following injection and subsequent removal of the drug at the completion of surgical procedures. Adequate animal reproduction studies were not conducted with VisionBlue® 0.06%, however, trypan blue has been shown to be teratogenic in various animal models at doses 800-fold and greater than the maximum recommended human dose, based on body surface area (BSA).

Due to the negligible human systemic exposure when used as recommended, it is not expected that maternal use of VisionBlue® 0.06% will result in fetal exposure to the drug and risk of teratogenic effects. Animal Data Trypan blue is teratogenic in rats, mice, rabbits, hamsters, dogs, guinea pigs, pigs, and chickens. The majority of teratogenicity studies performed involve intravenous, intraperitoneal, or subcutaneous administration in the rat.

The teratogenic dose is 50 mg/kg as a single dose or 25 mg/kg/day during embryogenesis in the rat. Normalized to BSA, these doses are approximately 1,600- and 800-fold the maximum recommended human dose of 0.3 mg per injection (based on a 60 kg person), assuming complete systemic absorption of trypan blue. Characteristic anomalies included neural tube, cardiovascular, vertebral, tail, and eye defects.

Trypan blue also caused an increase in post-implantation mortality and decreased fetal weight. In the monkey, trypan blue caused abortions with single or two daily doses of 50 mg/kg between 20th to 25th days of pregnancy, but no apparent increase in birth defects (approximately 3,200-fold the maximum recommended human dose based on BSA, assuming total absorption). Lactation Risk Summary The presence of trypan blue in human milk following intraocular administration of trypan blue has not been evaluated.

There are no data available regarding the effects of trypan blue on milk production. Breastfeeding is not expected to result in exposure of the child to trypan blue due to the negligible systemic exposure of trypan blue in humans following injection and subsequent removal of the drug at the completion of surgical procedures. Pediatric use The safety and effectiveness of trypan blue have been established in pediatric patients.

Use of trypan blue is supported by evidence from an adequate and well-controlled study in pediatric patients. Geriatric use No overall differences in safety and effectiveness have been observed between elderly and younger patients.

🤰 Pregnancy ~1 min read ▾

Pregnancy Risk Summary There are no available data on the use of VisionBlue® 0.06% in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Systemic absorption of VisionBlue® 0.06% in humans is expected to be negligible following injection and subsequent removal of the drug at the completion of surgical procedures. Adequate animal reproduction studies were not conducted with VisionBlue® 0.06%, however, trypan blue has been shown to be teratogenic in various animal models at doses 800-fold and greater than the maximum recommended human dose, based on body surface area (BSA).

Due to the negligible human systemic exposure when used as recommended, it is not expected that maternal use of VisionBlue® 0.06% will result in fetal exposure to the drug and risk of teratogenic effects. Animal Data Trypan blue is teratogenic in rats, mice, rabbits, hamsters, dogs, guinea pigs, pigs, and chickens. The majority of teratogenicity studies performed involve intravenous, intraperitoneal, or subcutaneous administration in the rat.

The teratogenic dose is 50 mg/kg as a single dose or 25 mg/kg/day during embryogenesis in the rat. Normalized to BSA, these doses are approximately 1,600- and 800-fold the maximum recommended human dose of 0.3 mg per injection (based on a 60 kg person), assuming complete systemic absorption of trypan blue. Characteristic anomalies included neural tube, cardiovascular, vertebral, tail, and eye defects.

Trypan blue also caused an increase in post-implantation mortality and decreased fetal weight. In the monkey, trypan blue caused abortions with single or two daily doses of 50 mg/kg between 20th to 25th days of pregnancy, but no apparent increase in birth defects (approximately 3,200-fold the maximum recommended human dose based on BSA, assuming total absorption).

🧒 Pediatric Use 32 words ▾

Pediatric use The safety and effectiveness of trypan blue have been established in pediatric patients. Use of trypan blue is supported by evidence from an adequate and well-controlled study in pediatric patients.

🧓 Geriatric Use 17 words ▾

Geriatric use No overall differences in safety and effectiveness have been observed between elderly and younger patients.

🧬 Clinical Pharmacology 86 words ▾

Clinical Pharmacology Mechanism of action VisionBlue® 0.06% selectively stains connective tissue structures in the human eye such as the anterior lens capsule of the human crystalline lens. VisionBlue® 0.06% is intended to be applied directly on the anterior lens capsule, staining any portion of the capsule which comes in contact with the dye. Excess dye is washed out of the anterior chamber.

The dye does not penetrate the capsule, permitting visualization of the anterior capsule in contrast to the non-stained lens cortex and inner lens material.

🧬 Mechanism of Action 84 words ▾

Mechanism of action VisionBlue® 0.06% selectively stains connective tissue structures in the human eye such as the anterior lens capsule of the human crystalline lens. VisionBlue® 0.06% is intended to be applied directly on the anterior lens capsule, staining any portion of the capsule which comes in contact with the dye. Excess dye is washed out of the anterior chamber.

The dye does not penetrate the capsule, permitting visualization of the anterior capsule in contrast to the non-stained lens cortex and inner lens material.

📦 How Supplied / Storage and Handling 69 words ▾

How Supplied/Storage and Handling VisionBlue® 0.06% is a clear, dark blue ophtalmic solution supplied as follows: 0.5 mL of VisionBlue® 0.06% in a sterile single-patient-use Luer Lok, 2.25 mL glass syringe, grey rubber plunger stopper and tip cap with polypropylene plunger rod in a peel pouch. Ten pouched products are packed in one distribution box. NDC 68803-612-05 (One 0,5 mL syringe) NDC 68803-612-10 (Carton of ten 0.5 mL syringes)

📦 Storage and Handling 12 words ▾

How Supplied/Storage and Handling Store between 15-25°C (59-77°F). Protect form direct sunlight.

📋 Description 151 words ▾

Description VisionBlue® (trypan blue ophthalmic solution) 0.06% is a sterile solution of trypan blue (an acid di-azo group dye) for intraocular ophtalmic use. VisionBlue® 0.06% is a selective tissue staining agent for use as a medical aid in ophthalmic surgery. Each mL of VisionBlue® 0.06% contains: 0.6 mg trypan blue; 1.9 mg sodium mono-hydrogen orthophosphate (Na 2 HPO 4 ·2H 2 O); 0.3 mg sodium di-hydrogen orthophosphate (NaH 2 PO 4 ·2H 2 O); 8.2 mg sodium chloride (NaCl); and water for injection.

Sodium hydroxide may be used to adjust pH. The pH is 7.3 – 7.6. The osmolality is 257-314 mOsm/kg.

The drug substance trypan blue has the chemical name 3,3’-[(3,3’-dimethyl-4,4’-biphenylylene) bis (azo)] bis (5-amino-4-hydroxy-2,7-naphthalenedisulfonic acid) tetra sodium salt, a molecular weight of 960.8, a molecular formula of C 34 H 24 N 6 Na 4 O 14 S 4 , and has the following chemical structure: Chemical structure VisionBlue

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 68796-5626-01 · Covenant 68803-0672-05 · Dutch →
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.