Phenylephrine Hydrochloride Solution
NDC Package 69315-323-08

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

Package Information

Phenylephrine Hydrochloride solution is phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil. This formulation utilizes a solution delivery system. Marketed by Leading Pharma, Llc, this product is identified by NDC 69315-323 and is authorized under FDA application ANDA215183.

Identification & Billing

NDC Package Code
69315-323-08
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 2 mL in 1 BOTTLE, DROPPER
Product Code
69315-323
11-Digit Billing Format
69315032308
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Phenylephrine Hydrochloride
Non-Proprietary Name
Phenylephrine Hydrochloride
Substance Name
Phenylephrine 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)
PHENYLEPHRINE HYDROCHLORIDE 25 mg/mL
Pharmacologic Class
Usage Information
Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil.

Regulatory & Marketing

Labeler Name
Leading Pharma, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA215183
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-05-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (69315-323). Click a package code to view its specific billing and regulatory data.

69315-323-15
1 BOTTLE, DROPPER in 1 CARTON / 15 mL in 1 BOTTLE, DROPPER

* 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 69315-323-08 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 2 ml in 1 bottle, dropper of Phenylephrine Hydrochloride, a human prescription drug labeled by Leading Pharma, Llc. This solution is formulated for ophthalmic use and contains phenylephrine 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 Leading Pharma, Llc on September 05, 2024. The current certification is valid through December 31, 2026.

How is this Leading Pharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69315032308. 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)
69315-323-08
11-Digit CMS (5-4-2)
69315-0323-08

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