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  5. NDC Package Code: 0713-0780-75 Promethazine Hydrochloride And Dextromethorphan Hydrobromide

NDC Package 0713-0780-75 Promethazine Hydrochloride And Dextromethorphan Hydrobromide

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

Table of Contents

    1. Package Information
    2. 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:
0713-0780-75
Package Description:
473 mL in 1 BOTTLE, PLASTIC
Product Code:
0713-0780
Proprietary Name:
Promethazine Hydrochloride And Dextromethorphan Hydrobromide
Non-Proprietary Name:
Promethazine Hydrochloride And Dextromethorphan Hydrobromide
Substance Name:
Dextromethorphan Hydrobromide; Promethazine Hydrochloride
Usage Information:
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.
11-Digit NDC Billing Format:
00713078075
Product Type:
Human Prescription Drug
Labeler Name:
Cosette Pharmaceuticals, 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:
No
FDA Application Number:
ANDA091687
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
09-19-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 0713-0780-75?

The NDC Packaged Code 0713-0780-75 is assigned to a package of 473 ml in 1 bottle, plastic of Promethazine Hydrochloride And Dextromethorphan Hydrobromide, a human prescription drug labeled by Cosette Pharmaceuticals, Inc.. The product's dosage form is solution and is administered via oral form.

Is NDC 0713-0780 included in the NDC Directory?

Yes, Promethazine Hydrochloride And Dextromethorphan Hydrobromide with product code 0713-0780 is active and included in the NDC Directory. The product was first marketed by Cosette Pharmaceuticals, Inc. on September 19, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 0713-0780-75?

The 11-digit format is 00713078075. 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 4-4-2 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 Format10-Digit Original Code11-Digit Format11-Digit Code
4-4-20713-0780-755-4-200713-0780-75