NDC Package 58657-504-08 Guaifenesin And Dextromethorphan Hydrobromide

Syrup 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:

58657-504-08

Package Description:

237 mL in 1 BOTTLE, PLASTIC

Product Code:

58657-504

Proprietary Name:

Guaifenesin And Dextromethorphan Hydrobromide

Non-Proprietary Name:

Guaifenesin And Dextromethorphan Hydrobromide

Substance Name:

Dextromethorphan Hydrobromide; Guaifenesin

Usage Information:

Do not take more than 6 doses in any 24-hour period. This adult product is not intended for use in children under 12 years of ageadults and children 12 years and over2 teaspoonfuls (TSP) every 4 hourschildren 6 to 12 years of age1 teaspoonful (TSP) every 4 hourschildren under 6 yearsDO NOT USE

11-Digit NDC Billing Format:

58657050408

Billing Unit:

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

NDC to RxNorm Crosswalk:

237 ML

NDC to RxNorm Crosswalk:

RxCUI: 996520 - dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution
RxCUI: 996520 - dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution
RxCUI: 996520 - dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution
RxCUI: 996520 - dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution
RxCUI: 996520 - dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution

Product Type:

Human Otc Drug

Labeler Name:

Method Pharmaceuticals

Dosage Form:

Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.

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:

04-01-2024

Listing Expiration Date:

12-31-2025

Exclude Flag:

Code Structure:

58657 - Method Pharmaceuticals
- 58657-504 - Guaifenesin And Dextromethorphan Hydrobromide
  - 58657-504-08 - 237 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 58657-504-08?

The NDC Packaged Code 58657-504-08 is assigned to a package of 237 ml in 1 bottle, plastic of Guaifenesin And Dextromethorphan Hydrobromide, a human over the counter drug labeled by Method Pharmaceuticals. The product's dosage form is syrup and is administered via oral form.

Is NDC 58657-504 included in the NDC Directory?

Yes, Guaifenesin And Dextromethorphan Hydrobromide with product code 58657-504 is active and included in the NDC Directory. The product was first marketed by Method Pharmaceuticals on April 01, 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 58657-504-08?

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 237.

What is the 11-digit format for NDC 58657-504-08?

The 11-digit format is 58657050408. 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	58657-504-08	5-4-2	58657-0504-08

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