Ddm Day Time And Nite Time Cold And Flu
NDC Package 51013-141-08

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.

Ddm Day Time And Nite Time Cold And Flu is take only as directed - see Overdose warningTake Nighttime or Daytimedo not exceed 4 doses per 24 hrs         AgeDaytime Nighttime adults and children 12 yrs & over 2 softgels with water every 4 hrs 2 softgels with water every 6 hrs children 4 to under 12 yrs ask a doctor ask a doctor children under 4 yrs do not usedo not useWhen using other Daytime or Nighttime products, carefully read each label to ensure correct dosing. Marketed by Puracap Pharmaceutical Llc, this product is identified by NDC 51013-141 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
51013-141-08
Package Description
1 KIT in 1 CARTON * 1 BLISTER PACK in 1 CARTON / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Product Code
51013-141
11-Digit Billing Format
51013014108
RxNorm Crosswalk
  • RxCUI: 1086997 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule
  • RxCUI: 1086997 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule
  • RxCUI: 1086997 - APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule
  • 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

Clinical Specifications

Proprietary Name
Ddm Day Time And Nite Time Cold And Flu
Dosage Form
-
Usage Information
Take only as directed - see Overdose warningTake Nighttime or Daytimedo not exceed 4 doses per 24 hrs         AgeDaytime Nighttime adults and children 12 yrs & over 2 softgels with water every 4 hrs 2 softgels with water every 6 hrs children 4 to under 12 yrs ask a doctor ask a doctor children under 4 yrs do not usedo not useWhen using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

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
06-20-2016
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 51013-141-08 identifies a specific commercial package of 1 kit in 1 carton * 1 blister pack in 1 carton / 10 capsule, liquid filled in 1 blister pack * 1 blister pack in 1 carton / 10 capsule, liquid filled in 1 blister pack of Ddm Day Time And Nite Time Cold And Flu, 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 June 20, 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: 51013014108. 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)
51013-141-08
11-Digit CMS (5-4-2)
51013-0141-08

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