NDC Package 53809-202-04 Dometuss

View Billable Units, 11-Digit Format, RxNorm

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:
53809-202-04
Package Description:
118 mL in 1 BOTTLE
Product Code:
Proprietary Name:
Dometuss
Usage Information:
Do not exceed more than 6 doses in any 24-hour periodAdults and children 12 years of age and overTake 1 teaspoonful (5 mL) every 4 hoursChildren 6 to under 12 years of ageTake 1/2 teaspoonful (2.5 mL) every 4 hoursChildren under 6 years of ageAsk a doctor
11-Digit NDC Billing Format:
53809020204
NDC to RxNorm Crosswalk:
  • RxCUI: 1489310 - chlorpheniramine maleate 4 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG in 5 mL Oral Solution
  • RxCUI: 1489310 - chlorpheniramine maleate 0.8 MG/ML / dextromethorphan hydrobromide 4 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral Solution
  • RxCUI: 1489310 - chlorpheniramine maleate 4 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 5 ML Oral Solution
Labeler Name:
Domel Laboratories
Sample Package:
No
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:
08-01-2015
Listing Expiration Date:
12-31-2024
Exclude Flag:
I
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 53809-202-04?

The NDC Packaged Code 53809-202-04 is assigned to a package of 118 ml in 1 bottle of Dometuss, labeled by Domel Laboratories. The product's dosage form is and is administered via form.

Is NDC 53809-202 included in the NDC Directory?

No, Dometuss with product code 53809-202 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Domel Laboratories on August 01, 2015 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 53809-202-04?

The 11-digit format is 53809020204. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-253809-202-045-4-253809-0202-04