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Fluorescein Sodium and Proparacaine Hydrochloride 2.5 mg/mL; 5 mg/mL Solution/ Drops — NDC 59390-0205-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Fluorescein Sodium and Proparacaine Hydrochloride 2.5 mg/mL; 5 mg/mL Solution/ Drops — NDC 59390-205-05 (Billing 59390-0205-05)

by Altaire Pharmaceuticals Inc. · 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER

This is a package of Fluorescein Sodium and Proparacaine Hydrochloride 2.5 mg/mL; 5 mg/mL Solution/ Drops from Altaire Pharmaceuticals Inc., marketed since Jun 2000 and currently FDA-listed. It is this product's only package size.

NDC 59390-0205-05
🏷️ FDA NDC (as labeled) 59390-205-05 billing pads the product segment with a zero
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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 59390-205-05 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
59390 labeler · 205 product · 05 package
Package marketed since
Jun 14, 2000
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0756641205051
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 59390-205-05
Product NDC 59390-205
11-digit billing NDC 59390020505
NCPDP billing unit ML — per mL (volume)
RxCUI 1247445
UNII 93X55PE38X, U96OL57GOY
UPC 0756641205051
SPL Set ID dae037ad-dcb8-42e6-8996-e575922d7631
Established class (EPC) Diagnostic Dye; Local Anesthetic
Mechanism of action Dyes
Physiologic effect Local Anesthesia
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2000-06-14
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance FLUORESCEIN SODIUM; PROPARACAINE HYDROCHLORIDE

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

GPI-14 86806010242010
GPI class Flucaine
GCN Seq No 048624
GCN 14119
HICL code 002907
Ingredient (HICL) Proparacaine/Fluorescein Sod
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 Q6H
Therapeutic class — specific (HIC3) Eye Local Anesthetics
AHFS code 36:58.00.00
AHFS class Ocular Disorders
FDB label name FLUORESCEIN-PROPARACAINE DROPS
FDB brand name Fluorescein-Proparacaine
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 048624
  • GCN: 14119
  • GPI-14 (Medi-Span): 86806010242010
  • HICL (First Databank): 002907
  • AHFS class code: 36:58.00.00
  • RxCUI (RxNorm): 1247445
Why two NDCs? The FDA registers this code as 59390-205-05 — 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 → 59390-0205-05. 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 Diagnostic Dye class.

Pharmacologic class Diagnostic Dye
Drug family (ATC) Colouring agents
How it works Dyes
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 FLUORESCEIN-PROPARACAINE DROPS Ingredient Proparacaine/Fluorescein Sod
🧪 What is this product?

This is an unapproved prescription eye drop solution containing fluorescein sodium and proparacaine hydrochloride. Fluorescein sodium is a dye typically used to highlight structures and problems in the eye during examination. Proparacaine hydrochloride is a local anesthetic commonly used to numb the eye surface before procedures or examination. Together, these ingredients are intended to assist in eye evaluation and minor eye procedures.

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.
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
59390-0205-05 You're viewing this Main listing 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER 2000-06-14 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Fluorescein Sodium and Proparacaine Hydrochloride 2.5 mg/mL; 5 mg/mLthis 59390-0205-05 Altaire 1 bottle — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
2000
On the market since
Jun 2000
📍
2026
Currently FDA-listed
26 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.

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 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 QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerAltaire Pharmaceuticals Inc.
Labeler code59390
First marketedJun 2000
Product typeHuman Prescription Drug
Portfolio12 products on file

More NDCs from Altaire Pharmaceuticals Inc. labeler code 59390

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.
⏱️ Dosage and Administration ⚠️ Warnings 🤒 Adverse Reactions 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
⏱️ Dosage and Administration 54 words ▾

DOSAGE AND ADMINISTRATION: Usual Dosage : Removal of foreign bodies and sutures, and for tonometry, 1 to 2 drops (in single instillations) in each eye before operating. Deep Ophthalmic Anesthesia : 1 drop in each eye every 5 to 10 minutes for 5-7 doses. NOTE : The use of an eye patch is recommended.

⚠️ Warnings 44 words ▾

WARNINGS: Avoid contamination - do not touch tip of sterile dropper used to dispense solution to any surface. Replace container closure immediately after using. Prolonged use of a topical ocular anesthetic is not recommended. It may product permanent corneal opacification with accompanying visual loss.

🤒 Adverse Reactions 79 words ▾

ADVERSE REACTIONS: Occasional temporary stinging, burning, and conjunctival redness have been reported after use of ocular anesthetics, as well as a rare, severe, immediate-type, apparent hyper-allergic corneal reaction, with acute, intense and diffuse epithelial keratitis, a gray, ground glass appearance, sloughing of large areas of necrotic epithelium, corneal filaments and sometimes, iritis with descementitis. Allergic contact dermatitis with drying and fissuring of the fingertips has been reported. To report SUSPECTED ADVERSE REACTIONS, contact Altaire Pharmaceuticals, Inc. at (631) 722-5988.

🧬 Clinical Pharmacology 47 words ▾

CLINICAL PHARMACOLOGY This product is the combination of a disclosing agent with a rapidly acting anesthetic of short duration. For procedures requiring a disclosing agent in combination with an anesthetic agent such as tonometry, gonioscopy, removal of corneal foreign bodies and other short corneal or conjunctival procedures.

📦 How Supplied / Storage and Handling 70 words ▾

HOW SUPPLIED: Fluorescein Sodium and Proparacaine Hydrochloride Ophthalmic Solution, USP (Sterile) is supplied in a glass or plastic bottle with a controlled tip applicator in the following sizes: 5 mL fill (glass bottle) with dropper DO NOT USE IS IMPRINTED SEAL ON CAP IS BROKEN OR MISSING. KEEP OUT OF REACH OF CHILDREN FOR OPHTHALMIC USE ONLY Manufactured By: Altaire Phamacueticals, Inc. 311 West Lane Aquebogue, NY 119311 Tel: 631-722-5988

📦 Storage and Handling 18 words ▾

STORAGE: Store in refrigerator at 2°-8°C (36°-46°F). Can be stored at room temperature for up to 1 month.

📋 Description 119 words ▾

DESCRIPTION: Fluorescein Sodium and Proparacaine Hydrochloride Ophthalmic Solution, USP (Sterile) is a sterile ophthalmic solution combining the disclosing action of Fluorescein with the anesthetic action of Proparacaine Hydrochloride. The active ingredient, Fluorescein Sodium , has the chemical name Spiro [isobenzofuran-1 (3H), 9'-[9H]xanthene]-3-one, 3' ,6' dihydroxy-,disodium salt. It is represented by the following structural formula: The active ingredient, Proparacaine Hydrochloride , has the chemical name Benzoic acid, 3-amino-4-propoxy-, 2-[diethylamino]ethyl ester monohydrochloride.

It is represented by the following structural formula: EACH mL CONTAINS : ACTIVES: Fluorescein Sodium, USP, 0.25% [2.5 mg]. Proparacaine Hydrochloride, USP, 0.5% [5mg]; INACTIVES: Povidone, Boric Acid, Water for Injection, Sodium Hydroxide, or/and Hydrochloric Acid may be added to adjust pH. PRESERVATIVE: Methylparaben 0.1%. structural formula structural formula

⚠️ Precautions 111 words ▾

PRECAUTIONS: This product should be used cautiously and sparingly in patients with known allergies, cardiac disease, or hyperthyroidism. The long-term toxicity is unknown; prolonged use may possibly delay wound healing. Although exceedingly rare with ophthalmic application of local anesthetics, it should be borne in mind that systemic toxicity manifested by central nervous system stimulation followed by depression may occur.

Protection of the eye from irritating chemicals, foreign bodies and rubbing during the period of anesthesia is very important. Tonometers soaked in sterilizing or detergent solutions should be thoroughly rinsed with sterile distilled water prior to use. Patients should be advised to avoid touching the eye until the anesthesia has worn off.

📄 Package Label / Principal Display Panel 24 words ▾

Principal Display Panel Fluorescein Sodium and Proparacaine Hydrochloride Ophthalmic Solutions, USP (STERILE) Rx Only 5 mL image description package insert image description iBottle 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 Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
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 Altaire Pharmaceuticals Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Altaire Pharmaceuticals 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.
← 59390-0198-50 · Altaire 59390-0217-02 · Altaire →
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.