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  5. NDC Package Code: 83393-777-01 Nighttime Cold And Flu

NDC Package 83393-777-01 Nighttime Cold And Flu

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing certification is expired.

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:
83393-777-01
Package Description:
30 mL in 1 BOTTLE, PLASTIC
Product Code:
83393-777
Proprietary Name:
Nighttime Cold And Flu
Usage Information:
Directionstake only as directed only use the dose cup provided do not exceed 4 doses per 24 hrs adults & children 12 yrs & over30 mL every 6 hrschildren 4 to under 12 yrsask a doctorchildren under 4 yrsdo not use
11-Digit NDC Billing Format:
83393077701
NDC to RxNorm Crosswalk:
  • RxCUI: 1043400 - acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution
  • RxCUI: 1043400 - acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution
  • RxCUI: 1043400 - acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution
  • RxCUI: 1043400 - acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution
  • RxCUI: 1043400 - APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution
Labeler Name:
Laboratorios Sanfer, S.a. De C.v.
Sample Package:
No
FDA Application Number:
M010
Marketing Category:
OTC MONOGRAPH DRUG -
Start Marketing Date:
04-11-2023
Listing Expiration Date:
12-31-2025
Exclude Flag:
E
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 83393-777-01?

The NDC Packaged Code 83393-777-01 is assigned to a package of 30 ml in 1 bottle, plastic of Nighttime Cold And Flu, labeled by Laboratorios Sanfer, S.a. De C.v.. The product's dosage form is and is administered via form.

Is NDC 83393-777 included in the NDC Directory?

No, Nighttime Cold And Flu with product code 83393-777 is excluded from the NDC Directory for failure to respond to FDA's requests for correction to deficient or non-compliant submissions. The product was first marketed by Laboratorios Sanfer, S.a. De C.v. on April 11, 2023 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 11-digit format for NDC 83393-777-01?

The 11-digit format is 83393077701. 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
5-3-283393-777-015-4-283393-0777-01