NDC 68071-4368-05 — Proparacaine Hydrochloride 5 mg/mL, 15 mL

🆔 Identity & classification

FDA NDC (as labeled) 68071-4368-5

Product NDC 68071-4368

11-digit billing NDC 68071436805

RxCUI 1191013

UNII U96OL57GOY

UPC 0368071436853

Application # ANDA040074

SPL Set ID 68a84d3f-a8f8-13ee-e053-2991aa0a7592

Established class (EPC) Local Anesthetic

Physiologic effect Local Anesthesia

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 1995-09-29

Route OPHTHALMIC

Dosage form SOLUTION/ DROPS

Substance PROPARACAINE HYDROCHLORIDE

TE code (Orange Book) AT · RLD · RS

Why two NDCs? The FDA registers this code as 68071-4368-5 — a 5-4-1 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 package segment → 68071-4368-05. 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 Local Anesthetic class.

Pharmacologic class Local Anesthetic

Drug family (ATC) Local anesthetics

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.

🏭 Manufacturer & labeler

LabelerNuCare Pharmaceuticals,Inc.

Application holderBAUSCH AND LOMB INC

FDA applicationANDA040074 (ANDA)

Labeler code68071

First marketedSep 1995

Product typeHuman Prescription Drug

Portfolio1,015 products on file

🔎 All NDCs from NuCare Pharmaceuticals,Inc.

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

Patient education

📘 MedlinePlus patient leaflet ↗

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.

🧪 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 PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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 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.

💲 Pricing

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

Price system	Per mL	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Proparacaine Hydrochloride 5 mg/mL 24208-0730-06	Bausch	1 bottle	$1.550	AT	Availability likely	—
Proparacaine Hydrochloride 5 mg/mL 61314-0016-01	Sandoz	1 bottle	$1.550	AT	Availability likely	—
Proparacaine Hydrochloride 5 mg/mL 70069-0601-01	Somerset	1 bottle	$1.550	AT	Availability likely	—
Proparacaine hydrochloride 5 mg/mL 70756-0193-35	Lifestar	1 bottle	$1.550	AT	Availability likely	—
Alcaine 5 mg/mL 00998-0016-15	Alcon	1 bottle	—	AT	FDA listed	—
Proparacaine hydrochloride 5 mg/mL 42571-0497-57	Micro	1 bottle	—	AT	FDA listed	—
Proparacaine Hydrochloride 5 mg/mL 50090-1923-00	A-S	1 bottle	—	AT	FDA listed	—
Proparacaine Hydrochloride 5 mg/mLthis 68071-4368-05	NuCare	15 ml	—	AT	FDA listed	—
proparacaine hydrochloride 5 mg/mL 68071-5139-05	NuCare	15 ml	—	AT	FDA listed	—
Proparacaine Hydrochloride 5 mg/mL 70518-3408-00	REMEDYREPACK	1 bottle	—	AT	FDA listed	—
Proparacaine Hydrochloride 5 mg/mL 85766-0039-15	Sportpharm	1 bottle	—	AT	FDA listed	—
Proparacaine Hydrochloride 5 mg/mL 85766-0056-15	Sportpharm	1 bottle	—	AT	FDA listed	—
Proparacaine Hydrochloride 5 mg/mL 85766-0057-15	Sportpharm	1 bottle	—	AT	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

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

🏛️

1995

On the market since

Sep 1995

📍

2026

Currently FDA-listed

31 years listed

🔓

·

Generic on the market

this product is a generic

✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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 Proparacaine hydrochloride — the ingredient across all brands.

Top reported reactions

Conjunctival Hyperaemia66

Eye Pain62

Drug Abuse59

Corneal Oedema55

Hypopyon53

Vision Blurred46

Corneal Epithelium Defect43

Reporter sex

Serious outcomes

Hospitalization133

Life-threatening34

Reports over time (by year) — tap or hover for the count & year

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 NDC	Description	Marketing start	Status
68071-4368-05 You're viewing this	15 mL in 1 BOX (68071-4368-5)	2018-03-30	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	✓ 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 FDA registers it as 68071-4368-5, 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: 68071-4368-05, written without dashes as 68071436805. 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 68071-4368-05, the first segment (68071) is the labeler code FDA assigned to NuCare Pharmaceuticals,Inc.; the middle segment (4368) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) 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 NuCare Pharmaceuticals,Inc.. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

NuCare 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.

📄 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 ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description

🎯 Indications and Usage 39 words ▾

INDICATIONS AND USAGE Proparacaine hydrochloride ophthalmic solution is indicated for procedures in which a topical ophthalmic anesthetic is indicated; corneal anesthesia of short duration, e.g. tonometry, gonioscopy, removal of corneal foreign bodies and for short corneal and conjunctival procedures.

⏱️ Dosage and Administration 74 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. Short corneal and conjunctival procedures: 1 drop in each eye every 5 to 10 minutes for 5 to 7 doses. NOTE: Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% should be clear, colorless to faint yellow color.

If the solution becomes darker, discard the solution. FOR TOPICAL OPHTHALMIC USE ONLY

⛔ Contraindications 20 words ▾

CONTRAINDICATIONS Proparacaine hydrochloride ophthalmic solution is contraindicated in patients with known hypersensitivity to any of the ingredients of this preparation.

⚠️ Warnings 33 words ▾

WARNINGS NOT FOR INJECTION INTO THE EYE - FOR TOPICAL OPHTHALMIC USE ONLY Prolonged use of a topical ocular anesthetic is not recommended. It may produce permanent corneal opacification with accompanying visual loss.

🤒 Adverse Reactions 94 words ▾

ADVERSE REACTIONS Occasional temporary stinging, burning and conjunctival redness may occur with the use of proparacaine. A rare, severe, immediate-type, apparently hyperallergic corneal reaction characterized by acute, intense and diffuse epithelial keratitis, a gray, ground glass appearance, sloughing of large areas of necrotic epithelium, corneal filaments and sometimes iritis with descemetitis has been reported. Allergic contact dermatitis from proparacaine with drying and fissuring of the fingertips has been reported.

To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🤰 Pregnancy 54 words ▾

Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%. It is also not known whether proparacaine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Proparacaine hydrochloride should be administered to a pregnant woman only if clearly needed.

🧒 Pediatric Use 47 words ▾

Pediatric Use Safety and effectiveness of proparacaine hydrochloride ophthalmic solution in pediatric patients have been established. Use of proparacaine hydrochloride is supported by evidence from adequate and well-controlled studies in adults and children over the age of twelve, and safety information in neonates and other pediatric patients.

🧓 Geriatric Use 20 words ▾

Geriatric Use No overall clinical differences in safety of effectiveness have been observed between the elderly and other adult patients.

🧬 Clinical Pharmacology 18 words ▾

CLINICAL PHARMACOLOGY Proparacaine hydrochloride ophthalmic solution is a rapidly-acting topical anesthetic, with induced anesthesia lasting approximately 10-20 minutes.

📦 How Supplied / Storage and Handling 33 words ▾

HOW SUPPLIED Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% is supplied in a plastic bottle with a controlled drop tip and a white polypropylene cap in the following size: NDC 68071-4368-5 bottles of 15mL

📦 Storage and Handling 53 words ▾

Storage Refrigerate at 2°-8°C (36°- 46°F). Protect from light. Keep tightly closed. DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. KEEP OUT OF REACH OF CHILDREN. Revised: July 2016 Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA ©Bausch & Lomb Incorporated 9114403 (Folded) 9114503 (Flat)

📋 Description 75 words ▾

DESCRIPTION Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% is a topical local anesthetic for ophthalmic use. The active ingredient is represented by the structural formula: Established name: Proparacaine Hydrochloride Chemical name: Benzoic acid, 3-amino-4-propoxy-,2-(diethylamino) ethyl ester, monohydrochloride Molecular weight: 330.85 Each mL contains: Active : proparacaine hydrochloride 5 mg (0.5%). Inactives : glycerin and purified water.

The pH may be adjusted with hydrochloric acid and/or sodium hydroxide. Preservative: b enzalkonium chloride (0.01%). Proparacaine Hydrochloride (structural formula)

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

Active ingredient: The part of a medicine that produces its intended effect on the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

contact dermatitis: A skin rash caused by touching something that irritates the skin or triggers an allergy.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

dermatitis: Inflammation of the skin, causing redness, itching, and sometimes swelling or blisters.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

pregnancy category: An older letter rating (A, B, C, D, or X) once used to describe a medicine's possible risk during pregnancy.

topical: Applied onto the skin, eyes, or another body surface to work mainly where it is placed.

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

🔗 Related NDC lookups

🧪 All Proparacaine Hydrochloride NDCsSame ingredient 🏭 All NuCare labeler NDCsLabeler code 68071 📚 All Local Anesthetic NDCsDrug class

Proparacaine Hydrochloride 5 mg/mL Solution/ Drops, 15 mL

🆔 Identity & classification

🏷️ RxNorm drug class

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

🔬 Reported adverse events (FAERS)

Top reported reactions

Reporter sex

Serious outcomes

📦 Packaging — all sizes for this product

🧭 About this NDC listing & data coverage

Questions about this listing

📄 Full prescribing information FDA SPL

🔗 Related NDC lookups