Nighttime Cold And Flu
NDC Package 70005-005-50

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

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

Nighttime Cold And Flu is take only as directed - see Liver warningdo not exceed 8 softgels per 24 hoursadults and children 12 years and over: 2 softgels with water every 6 hourschildren 4 to under 12 years: ask a doctorchildren under 4 years: do not usewhen using other Daytime or Nighttime products, carefully read each label to insure correct dosing. Marketed by We Care Distributor Inc., this product is identified by NDC 70005-005 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
70005-005-50
Package Description
50 POUCH in 1 BOX / 2 CAPSULE, LIQUID FILLED in 1 POUCH
Product Code
70005-005
11-Digit Billing Format
70005000550
RxNorm Crosswalk
  • RxCUI: 1094549 - acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule
  • RxCUI: 1094549 - acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule
  • RxCUI: 1094549 - APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule

Clinical Specifications

Proprietary Name
Nighttime Cold And Flu
Dosage Form
-
Usage Information
Take only as directed - see Liver warningdo not exceed 8 softgels per 24 hoursadults and children 12 years and over: 2 softgels with water every 6 hourschildren 4 to under 12 years: ask a doctorchildren under 4 years: do not usewhen using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Regulatory & Marketing

Labeler Name
We Care Distributor Inc.
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
02-17-2016
Listing Expiration
12-31-2019
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70005-005). Click a package code to view its specific billing and regulatory data.

70005-005-02
2 POUCH in 1 POUCH / 2 CAPSULE, LIQUID FILLED in 1 POUCH
70005-005-25
25 POUCH in 1 BOX / 2 CAPSULE, LIQUID FILLED in 1 POUCH

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70005-005-50 identifies a specific commercial package of 50 pouch in 1 box / 2 capsule, liquid filled in 1 pouch of Nighttime Cold And Flu, labeled by We Care Distributor Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by We Care Distributor Inc. on February 17, 2016. The current certification is valid through December 31, 2019.

How is this We Care Distributor Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70005000550. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
70005-005-50
11-Digit CMS (5-4-2)
70005-0005-50

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.