Nite Time Cold And Cough
NDC Package 45014-159-04

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

Package Information

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

Nite Time Cold And Cough May be given every 4 hoursdo not use more than 6 times in 24 hoursuse only enclosed dosing cup to dose this product. Marketed by Accudial Pharmaceutical, Inc., this product is identified by NDC 45014-159 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
45014-159-04
Package Description
118 mL in 1 BOTTLE
Product Code
45014-159
11-Digit Billing Format
45014015904
RxNorm Crosswalk
  • RxCUI: 1236048 - diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution
  • RxCUI: 1236048 - diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution
  • RxCUI: 1236048 - diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution
  • RxCUI: 1236048 - diphenhydramine HCl 6.25 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution

Clinical Specifications

Proprietary Name
Nite Time Cold And Cough
Dosage Form
-
Usage Information
May be given every 4 hoursdo not use more than 6 times in 24 hoursuse only enclosed dosing cup to dose this product. Do not use any other dosing device.

Regulatory & Marketing

Labeler Name
Accudial Pharmaceutical, 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
02-01-2013
Listing Expiration
12-31-2017
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 45014-159-04 identifies a specific commercial package of 118 ml in 1 bottle of Nite Time Cold And Cough, labeled by Accudial Pharmaceutical, 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 Accudial Pharmaceutical, Inc. on February 01, 2013. The current certification is valid through December 31, 2017.

How is this Accudial Pharmaceutical, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45014015904. 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)
45014-159-04
11-Digit CMS (5-4-2)
45014-0159-04

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