NDC Package 50383-063-07 Guaifenesin

View Billable Units, 11-Digit Format, RxNorm

Package Information
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Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

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:

50383-063-07

Package Description:

10 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE

Product Code:

50383-063

Proprietary Name:

Guaifenesin

Usage Information:

Follow dosage below or use as directed by a physician.do not take more than 6 doses in any 24-hour periodagedoseadults and children 12 years and over10 to 20 mL (2 to 4 teaspoonfuls) every 4 hourschildren 6 years to under 12 years5 to 10 mL (1 to 2 teaspoonfuls) every 4 hourschildren 2 to under 6 years of age2.5 to 5 mL (1/2 to 1 teaspoonful) every 4 hourschildren under 2 years of ageask a doctorHow Supplied:Guaifenesin Oral Solution is a clear viscous liquid with a slight cherry odor supplied in the following oral dosage forms: 5 mL unit dose, 10 mL unit dose, 15 mL unit dose in trays of 10 and 4 fl. oz. (118 mL) bottlePhenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)

11-Digit NDC Billing Format:

50383006307

Billing Unit:

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

NDC to RxNorm Crosswalk:

RxCUI: 310604 - guaiFENesin 100 MG in 5 mL Oral Solution
RxCUI: 310604 - guaifenesin 20 MG/ML Oral Solution
RxCUI: 310604 - guaifenesin 100 MG per 5 ML Oral Solution
RxCUI: 310604 - guaifenesin 100 MG per 5 ML Oral Syrup
RxCUI: 310604 - guaifenesin 200 MG per 10 ML Oral Solution

Labeler Name:

Akorn

Sample Package:

FDA Application Number:

part341

Marketing Category:

OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.

Start Marketing Date:

03-07-2012

Listing Expiration Date:

12-31-2023

Exclude Flag:

Code Structure:

50383 - Akorn
- 50383-063 - Guaifenesin
  - 50383-063-07 - 10 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE

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
50383-063-06	4 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY (50383-063-05) / 5 mL in 1 CUP, UNIT-DOSE
50383-063-11	4 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY (50383-063-10) / 10 mL in 1 CUP, UNIT-DOSE
50383-063-12	10 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE
50383-063-17	4 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY (50383-063-15) / 15 mL in 1 CUP, UNIT-DOSE
50383-063-18	10 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 50383-063-07?

The NDC Packaged Code 50383-063-07 is assigned to a package of 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 ml in 1 cup, unit-dose of Guaifenesin, labeled by Akorn. The product's dosage form is and is administered via form.

Is NDC 50383-063 included in the NDC Directory?

No, Guaifenesin with product code 50383-063 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Akorn on March 07, 2012 and its listing in the NDC Directory is set to expire on December 31, 2023 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 50383-063-07?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

What is the 11-digit format for NDC 50383-063-07?

The 11-digit format is 50383006307. 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	50383-063-07	5-4-2	50383-0063-07

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