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

Solution Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

64950-345-16

Package Description:

473 mL in 1 BOTTLE, PLASTIC

Product Code:

64950-345

Proprietary Name:

Promethazine Hydrochloride And Phenylephrine Hydrochloride

Non-Proprietary Name:

Promethazine Hydrochloride And Phenylephrine Hydrochloride

Substance Name:

Phenylephrine Hydrochloride; Promethazine Hydrochloride

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.

11-Digit NDC Billing Format:

64950034516

Billing Unit:

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

NDC to RxNorm Crosswalk:

473 ML

NDC to 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

Product Type:

Human Prescription Drug

Labeler Name:

Genus Lifesciences Inc.

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(s):

Oral - Administration to or by way of the mouth.

Active Ingredient(s):

Pharmacologic Class(es):

Sample Package:

FDA Application Number:

ANDA040654

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

07-15-2024

Listing Expiration Date:

12-31-2025

Exclude Flag:

Code Structure:

64950 - Genus Lifesciences Inc.
- 64950-345 - Promethazine Hydrochloride And Phenylephrine Hydrochloride
  - 64950-345-16 - 473 mL in 1 BOTTLE, PLASTIC

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 disclaimer below.

Frequently Asked Questions

What is NDC 64950-345-16?

The NDC Packaged Code 64950-345-16 is assigned to a package of 473 ml in 1 bottle, plastic of Promethazine Hydrochloride And Phenylephrine Hydrochloride, a human prescription drug labeled by Genus Lifesciences Inc.. The product's dosage form is solution and is administered via oral form.

Is NDC 64950-345 included in the NDC Directory?

Yes, Promethazine Hydrochloride And Phenylephrine Hydrochloride with product code 64950-345 is active and included in the NDC Directory. The product was first marketed by Genus Lifesciences Inc. on July 15, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 64950-345-16?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 473.

What is the 11-digit format for NDC 64950-345-16?

The 11-digit format is 64950034516. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	64950-345-16	5-4-2	64950-0345-16

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