Tetracaine Hydrochloride Solution
NDC Package 70069-596-01

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 Somerset Therapeutics, Llc, this product is identified by NDC 70069-596 and is authorized under FDA application ANDA217227.

Identification & Billing

NDC Package Code
70069-596-01
Package Description
1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE
Product Code
70069-596
11-Digit Billing Format
70069059601
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
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
Somerset Therapeutics, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA217227
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-23-2024
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 70069-596-01 identifies a specific commercial package of 1 bottle in 1 carton / 5 ml in 1 bottle of Tetracaine Hydrochloride, a human prescription drug labeled by Somerset Therapeutics, Llc. 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 Somerset Therapeutics, Llc on December 23, 2024. The current certification is valid through December 31, 2026.

How is this Somerset Therapeutics, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70069059601. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
70069-596-01
11-Digit CMS (5-4-2)
70069-0596-01

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