Night Time Cold And Flu Formula
NDC Package 51013-162-08

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.

Night Time Cold And Flu Formula is do not take more than the recommended doseadults and children 12 years and over: take 2 softgels with water every 4 hours. Marketed by Puracap Pharmaceutical Llc, this product is identified by NDC 51013-162 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
51013-162-08
Package Description
2 BLISTER PACK in 1 CARTON / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Product Code
51013-162
11-Digit Billing Format
51013016208
RxNorm Crosswalk
  • RxCUI: 1297288 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule
  • RxCUI: 1297288 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule
  • RxCUI: 1297288 - APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule

Clinical Specifications

Proprietary Name
Night Time Cold And Flu Formula
Dosage Form
-
Usage Information
Do not take more than the recommended doseadults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.children under 12 years: do not use

Regulatory & Marketing

Labeler Name
Puracap Pharmaceutical Llc
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
07-14-2016
Listing Expiration
12-31-2024
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 51013-162-08 identifies a specific commercial package of 2 blister pack in 1 carton / 10 capsule, liquid filled in 1 blister pack of Night Time Cold And Flu Formula, labeled by Puracap Pharmaceutical Llc. 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 Puracap Pharmaceutical Llc on July 14, 2016. The current certification is valid through December 31, 2024.

How is this Puracap Pharmaceutical Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51013016208. 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)
51013-162-08
11-Digit CMS (5-4-2)
51013-0162-08

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