Proparacaine Hydrochloride Solution/ Drops
NDC Package 42571-497-57

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Proparacaine Hydrochloride solution/ dropses is proparacaine Hydrochloride Ophthalmic solution is indicated for topical anesthesia in ophthalmic practice. This formulation utilizes a solution/ drops delivery system. Marketed by Micro Labs Limited, this product is identified by NDC 42571-497 and is authorized under FDA application ANDA219294.

Identification & Billing

NDC Package Code
42571-497-57
Package Description
1 BOTTLE in 1 CARTON / 15 mL in 1 BOTTLE
Product Code
42571-497
11-Digit Billing Format
42571049757
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Proparacaine Hydrochloride
Non-Proprietary Name
Proparacaine Hydrochloride
Substance Name
Proparacaine Hydrochloride
Dosage Form
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
PROPARACAINE HYDROCHLORIDE 5 mg/mL
Pharmacologic Class
Usage Information
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.

Regulatory & Marketing

Labeler Name
Micro Labs Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA219294
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-01-2026
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 42571-497-57 identifies a specific commercial package of 1 bottle in 1 carton / 15 ml in 1 bottle of Proparacaine Hydrochloride, a human prescription drug labeled by Micro Labs Limited. This solution/ drops is formulated for ophthalmic use and contains proparacaine hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Micro Labs Limited on February 01, 2026. The current certification is valid through December 31, 2026.

How is this Micro Labs Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42571049757. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
42571-497-57
11-Digit CMS (5-4-2)
42571-0497-57

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.