NDC Package 80587-183-02 Duratuss DM

Dexbrompheniramine Maleate,Dextromethorphan Hydrobromide And Pseudoephedrine Hydrochloride - View Billable Units, 11-Digit Format, RxNorm

Package Information
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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:

80587-183-02

Package Description:

473 mL in 1 BOTTLE

Product Code:

80587-183

Proprietary Name:

Duratuss DM

Non-Proprietary Name:

Dexbrompheniramine Maleate, Dextromethorphan Hydrobromide And Pseudoephedrine Hydrochloride

Substance Name:

Dexbrompheniramine Maleate; Dextromethorphan Hydrobromide; Pseudoephedrine Hydrochloride

Usage Information:

Do not exceed recommended dosage.Adults and children 12 years of age and over: 2 teaspoonful (10 mL) every 4 to 6 hours, not to exceed 8 teaspoonfuls in a 24 hours Children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 4 teaspoonfuls in 24 hours Children under 6 years of age: Consult a doctor.

11-Digit NDC Billing Format:

80587018302

Product Type:

Human Otc Drug

Labeler Name:

Prime Labs Llc Dba Quality Cdmo

Dosage Form:

Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Administration Route(s):

Oral - Administration to or by way of the mouth.

Active Ingredient(s):

Pharmacologic Class(es):

Sample Package:

FDA Application Number:

M012

Marketing Category:

OTC MONOGRAPH DRUG -

Start Marketing Date:

09-25-2025

Listing Expiration Date:

12-31-2026

Exclude Flag:

Code Structure:

80587 - Prime Labs Llc Dba Quality Cdmo
- 80587-183 - Duratuss
  - 80587-183-02 - 473 mL in 1 BOTTLE

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.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
80587-183-01	20 mL in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 80587-183-02?

The NDC Packaged Code 80587-183-02 is assigned to a package of 473 ml in 1 bottle of Duratuss DM, a human over the counter drug labeled by Prime Labs Llc Dba Quality Cdmo. The product's dosage form is liquid and is administered via oral form.

Is NDC 80587-183 included in the NDC Directory?

Yes, Duratuss DM with product code 80587-183 is active and included in the NDC Directory. The product was first marketed by Prime Labs Llc Dba Quality Cdmo on September 25, 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 80587-183-02?

The 11-digit format is 80587018302. 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	80587-183-02	5-4-2	80587-0183-02

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