Tetracaine Hydrochloride Solution
NDC Package 70518-4183-0

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

Package Information

Tetracaine Hydrochloride solution is tetracaine Hydrochloride Ophthalmic Solution 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. This formulation utilizes a solution delivery system. Marketed by Remedyrepack Inc., this product is identified by NDC 70518-4183 and is authorized under FDA application NDA208135.

Identification & Billing

NDC Package Code
70518-4183-0
Package Description
12 BOTTLE, DROPPER in 1 CARTON / 4 mL in 1 BOTTLE, DROPPER (70518-4183-1)
Product Code
70518-4183
11-Digit Billing Format
70518418300
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tetracaine Hydrochloride
Non-Proprietary Name
Tetracaine Hydrochloride
Substance Name
Tetracaine Hydrochloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
TETRACAINE HYDROCHLORIDE 5 mg/mL
Pharmacologic Class
Usage Information
Tetracaine Hydrochloride Ophthalmic Solution 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic.

Regulatory & Marketing

Labeler Name
Remedyrepack Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA208135
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-24-2024
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 70518-4183-0 identifies a specific commercial package of 12 bottle, dropper in 1 carton / 4 ml in 1 bottle, dropper (70518-4183-1) of Tetracaine Hydrochloride, a human prescription drug labeled by Remedyrepack Inc.. This solution is formulated for ophthalmic use and contains tetracaine 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 Remedyrepack Inc. on September 24, 2024. The current certification is valid through December 31, 2026.

How is this Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70518418300. 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)
70518-4183-0
11-Digit CMS (5-4-2)
70518-4183-00

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