Promethazine Hydrochloride And Phenylephrine Hydrochloride Solution
NDC Package 64950-345-16

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

Package Information

Promethazine Hydrochloride And Phenylephrine Hydrochloride solution is promethazine hydrochloride and phenylephrine hydrochloride oral solution is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold. This formulation utilizes a solution delivery system. Marketed by Genus Lifesciences Inc., this product is identified by NDC 64950-345 and is authorized under FDA application ANDA040654.

Identification & Billing

NDC Package Code
64950-345-16
Package Description
473 mL in 1 BOTTLE, PLASTIC
Product Code
64950-345
11-Digit Billing Format
64950034516
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
473 ML
RxNorm Crosswalk
  • RxCUI: 1248057 - phenylephrine HCl 5 MG / promethazine HCl 6.25 MG in 5 mL Oral Solution
  • RxCUI: 1248057 - phenylephrine hydrochloride 1 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution
  • RxCUI: 1248057 - phenylephrine hydrochloride 5 MG / promethazine hydrochloride 6.25 MG per 5 ML Oral Solution

Clinical Specifications

Proprietary Name
Promethazine Hydrochloride And Phenylephrine Hydrochloride
Non-Proprietary Name
Promethazine Hydrochloride And Phenylephrine Hydrochloride
Substance Name
Phenylephrine Hydrochloride; Promethazine 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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Promethazine hydrochloride and phenylephrine hydrochloride oral solution is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

Regulatory & Marketing

Labeler Name
Genus Lifesciences Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA040654
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-15-2024
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 64950-345-16 identifies a specific commercial package of 473 ml in 1 bottle, plastic of Promethazine Hydrochloride And Phenylephrine Hydrochloride, a human prescription drug labeled by Genus Lifesciences Inc.. This solution is formulated for oral use and contains phenylephrine hydrochloride; promethazine 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 Genus Lifesciences Inc. on July 15, 2024. The current certification is valid through December 31, 2026.

How is this Genus Lifesciences Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64950034516. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 473 total billable units per package. 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)
64950-345-16
11-Digit CMS (5-4-2)
64950-0345-16

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