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Proparacaine hydrochloride 5 mg/mL Solution/ Drops — NDC 42571-497-57 (Billing 42571-0497-57)

by Micro Labs Limited · 1 BOTTLE in 1 CARTON / 15 mL in 1 BOTTLE

This is a package of Proparacaine hydrochloride 5 mg/mL Solution/ Drops from Micro Labs Limited, marketed since Feb 2026 and currently FDA-listed; retail pharmacies pay about $1.47 per mL (NADAC). It is this product's only package size.

NDC 42571-0497-57
🏷️ FDA NDC (as labeled) 42571-497-57 billing pads the product segment with a zero
Rx only Generic 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 42571-497-57 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
42571 labeler · 497 product · 57 package
Package marketed since
Feb 1, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0342571497576
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 42571-497-57
Product NDC 42571-497
11-digit billing NDC 42571049757
NCPDP billing unit ML — per mL (volume)
RxCUI 1191013
UNII U96OL57GOY
UPC 0342571497576
Application # ANDA219294
SPL Set ID df1af0e8-7d9d-4511-9d86-f0c31a5da2c2
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 2026-02-01
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance PROPARACAINE HYDROCHLORIDE
TE code (Orange Book) AT · RLD · RS
Quick answers
  • RxCUI (RxNorm): 1191013
Why two NDCs? The FDA registers this code as 42571-497-57 — 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 → 42571-0497-57. 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.

Clinical

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 $1.470 $22.05 / 15 ml
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.
NADAC price history (per mL) — tap or hover for the price & month
Sep 2026 $1.470 $1.470
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
42571-0497-57 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 15 mL in 1 BOTTLE 2026-02-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Proparacaine Hydrochloride 5 mg/mL 24208-0730-06 Bausch 1 bottle $1.470 AT Availability likely —
Proparacaine hydrochloride 5 mg/mLthis 42571-0497-57 Micro 1 bottle $1.470 AT Availability likely —
Proparacaine Hydrochloride 5 mg/mL 61314-0016-01 Sandoz 1 bottle $1.470 AT Availability likely —
Proparacaine Hydrochloride 5 mg/mL 70069-0601-01 Somerset 1 bottle $1.470 AT Availability likely —
Proparacaine hydrochloride 5 mg/mL 70756-0193-35 Lifestar 1 bottle $1.470 AT Availability likely —
Alcaine 5 mg/mL 00998-0016-15 Alcon 1 bottle — AT FDA listed —
Proparacaine Hydrochloride 5 mg/mL 50090-1923-00 A-S 1 bottle — AT FDA listed —
Proparacaine Hydrochloride 5 mg/mL 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

🏛️
2026
On the market since
Feb 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerMicro Labs Limited
Application holderMICRO LABS LTD
FDA applicationANDA219294 (ANDA)
Labeler code42571
First marketedFeb 2026
Product typeHuman Prescription Drug
Portfolio196 products on file

More NDCs from Micro Labs Limited labeler code 42571

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 ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 66 words ▾

INDICATIONS AND USAGE Proparacaine Hydrochloride Ophthalmic solution is indicated for topical anesthesia in ophthalmic practice. Representative ophthalmic procedures in which the preparation provides good local anesthesia include measurement of intraocular pressure (tonometry), removal of foreign bodies and sutures from the cornea, conjunctival scraping in diagnosis and gonioscopic examination; it is also indicated for use as a topical anesthetic prior to surgical operations such as cataract extraction.

⏱️ Dosage and Administration 63 words ▾

DOSAGE AND ADMINISTRATION Deep anesthesia as in cataract extraction : Instill 1 drop every 5 to 10 minutes for 5 to 7 doses. Removal of sutures : Instill 1 or 2 drops 2 or 3 minutes before removal of stitches. Removal of foreign bodies : Instill 1 or 2 drops prior to operating. Tonometry : Instill 1 or 2 drops immediately before measurement

⛔ Contraindications 16 words ▾

CONTRAINDICATIONS This preparation is contraindicated in patients with known hypersensitivity to any component of the solution.

⚠️ Warnings 49 words ▾

WARNINGS For topical ophthalmic use only. Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification with accompanying loss of visual. Proparacaine hydrochloride ophthalmic solution is indicated for administration under the direct supervision of a healthcare provider. Proparacaine hydrochloride ophthalmic solution is not intended for patient self-administration.

🤒 Adverse Reactions 157 words ▾

ADVERSE REACTIONS Pupillary dilation or cycloplegic effects have rarely been observed with proparacaine hydrochloride. The drug appears to be safe for use in patients sensitive to other local anesthetics, but local or systemic sensitivity occasionally occurs. Instillation of proparacaine in the eye at recommended concentration and dosage usually produces little or no initial irritation, stinging, burning, conjunctival redness, lacrimation or increased winking.

However, some local irritation and stinging may occur several hours after the instillation. Rarely, a severe, immediate-type, apparently hyperallergic corneal reaction may occur which includes 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. Allergic contact dermatitis with drying and fissuring of the fingertips has been reported.

Softening and erosion of the corneal epithelium and conjunctival congestion and hemorrhage have been reported. To report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA, Inc., at 1-855-839-8195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🤰 Pregnancy 50 words ▾

Pregnancy Animal reproduction studies have not been conducted with proparacaine hydrochloride ophthalmic solution, 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 or effectiveness have been observed between the elderly and other adult patients.

🧬 Clinical Pharmacology 170 words ▾

CLINICAL PHARMACOLOGY Proparacaine hydrochloride ophthalmic solution is a rapid acting local anesthetic suitable for ophthalmic use. With a single drop, the onset of anesthesia occurs in approximately 13 seconds and persists for 15 minutes or longer. The main site of anesthetic action is the nerve cell membrane where proparacaine interferes with the large transient increase in the membrane permeability to sodium ions that is normally produced by a slight depolarization of the membrane.

As the anesthetic action progressively develops in a nerve, the threshold for electrical stimulation gradually increases and the safety factor for conduction decreases; when this action is sufficiently well developed, block of conduction is produced. The exact mechanism whereby proparacaine and other local anesthetics influence the permeability of the cell membrane is unknown; however, several studies indicate that local anesthetics may limit sodium ion permeability by closing the pores through which the ions migrate in the lipid layer of the nerve cell membrane.

This limitation prevents the fundamental change necessary for the generation of the action potential.

📦 How Supplied / Storage and Handling 105 words ▾

HOW SUPPLIED Proparacaine hydrochloride ophthalmic solution USP, 0.5% is supplied in a 3-piece white low density polyethylene S design container with natural low density polyethylene S design open nozzle and white color high density polyethylene S design cap with TSTR- tear off ring. 15 mL fill in 15 mL Container NDC 42571-497-57 Storage: Refrigerate at 2° to 8° C. Keep bottle tightly closed.

Store bottles in carton until empty to protect from light. If solution shows more than a faint yellow color, it should not be used. Manufactured by: Micro Labs Limited Bangalore-560099, INDIA Manufactured for: Micro Labs USA, Inc.

Somerset, NJ 08873 Rev. 01/2025

📋 Description 93 words ▾

DESCRIPTION Proparacaine hydrochloride ophthalmic solution USP, 0.5% is a local anesthetic for ophthalmic instillation. Each mL of sterile aqueous solution contains active ingredient: proparacaine hydrochloride 5 mg (0.5%) and inactive ingredients: glycerin (tonicity agent), benzalkonium chloride, 0.01% (preservative) and water for injection (vehicle). The pH may be adjusted with hydrochloric acid and/or sodium hydroxide.

At the time of manufacture, the air in the container is replaced by nitrogen. Proparacaine hydrochloride is designated chemically as 2-(Diethylamino) ethyl 3-amino-4-propoxybenzoate monohydrochloride. Graphic formula: C 16 H 26 N 2 O 3 •HCl MW 330.85 CAS-5875-06-9 proparacaine-stru

⚠️ Precautions ~1 min read ▾

PRECAUTIONS General Proparacaine should be used cautiously and sparingly in patients with known allergies, cardiac disease, or hyperthyroidism. The long-term toxicity of proparacaine 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.

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate carcinogenic potential, mutagenicity, or possible impairment of fertility in males or females. Pregnancy Animal reproduction studies have not been conducted with proparacaine hydrochloride ophthalmic solution, 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. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when proparacaine hydrochloride is administered to a nursing woman.

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

🍼 Nursing Mothers 35 words ▾

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when proparacaine hydrochloride is administered to a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 27 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate carcinogenic potential, mutagenicity, or possible impairment of fertility in males or females.

📄 Package Label / Principal Display Panel 26 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 42571-497-57 Rx only Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% For eye use only 15 mL Sterile Micro Labs Limited proparacaine-lbl.jpg proparacaine-crtn.jpg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 42571-0477-47 · Micro 42571-0499-06 · Micro →
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.