Tetracaine Hydrochloride
NDC Package 76519-1118-5

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Tetracaine Hydrochloride is for procedures in which a rapid and short-acting topical ophthalmic anesthetic is indicated such as in tonometry, gonioscopy, removal of corneal foreign bodies, conjunctival scraping for diagnostic purposes, suture removal from the cornea, other short corneal and conjunctival procedures. Marketed by H.j. Harkins Company, Inc., this product is identified by NDC 76519-1118.

Identification & Billing

NDC Package Code
76519-1118-5
Package Description
15 mL in 1 BOTTLE, DROPPER
Product Code
76519-1118
11-Digit Billing Format
76519111805
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tetracaine Hydrochloride
Dosage Form
-
Usage Information
For procedures in which a rapid and short-acting topical ophthalmic anesthetic is indicated such as in tonometry, gonioscopy, removal of corneal foreign bodies, conjunctival scraping for diagnostic purposes, suture removal from the cornea, other short corneal and conjunctival procedures.

Regulatory & Marketing

Labeler Name
H.j. Harkins Company, Inc.
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
01-28-2016
Listing Expiration
12-31-2019
Exclude Flag
I
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 76519-1118-5 identifies a specific commercial package of 15 ml in 1 bottle, dropper of Tetracaine Hydrochloride, labeled by H.j. Harkins Company, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by H.j. Harkins Company, Inc. on January 28, 2016. The current certification is valid through December 31, 2019.

How is this H.j. Harkins Company, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76519111805. 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 (5-4-1)
76519-1118-5
11-Digit CMS (5-4-2)
76519-1118-05

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