Naproxen Sodium And Pseudoephedrine Hydrochloride Cold And Sinus Tablet, Extended Release
NDC Package 71179-816-24

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

Package Information

Naproxen Sodium And Pseudoephedrine Hydrochloride Cold And Sinus (naproxen sodium and pseudoephedrine hydrochloride) tablets is do not take more than directedthe smallest effective dose should be usedswallow whole; do not crush or chewdrink a full glass of water with each doseadults and children 12 years and older: 1 caplet every 12 hours; do not take more than 2 caplets in 24 hourschildren under 12 years: do not use. This formulation utilizes a tablet, extended release delivery system. Marketed by Vespyr Brands Llc, this product is identified by NDC 71179-816 and is authorized under FDA application ANDA211360.

Identification & Billing

NDC Package Code
71179-816-24
Package Description
3 BLISTER PACK in 1 CARTON / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
71179-816
11-Digit Billing Format
71179081624
RxNorm Crosswalk
  • RxCUI: 1367426 - naproxen sodium 220 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1367426 - 12 HR naproxen sodium 220 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet
  • RxCUI: 1367426 - naproxen sodium 220 MG / pseudoephedrine hydrochloride 120 MG 12 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Naproxen Sodium And Pseudoephedrine Hydrochloride Cold And Sinus
Non-Proprietary Name
Naproxen Sodium And Pseudoephedrine Hydrochloride
Substance Name
Naproxen Sodium; Pseudoephedrine Hydrochloride
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Do not take more than directedthe smallest effective dose should be usedswallow whole; do not crush or chewdrink a full glass of water with each doseadults and children 12 years and older: 1 caplet every 12 hours; do not take more than 2 caplets in 24 hourschildren under 12 years: do not use

Regulatory & Marketing

Labeler Name
Vespyr Brands Llc
Product Type
Human Otc Drug
FDA Application #
ANDA211360
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-07-2024
Listing Expiration
12-31-2027
Exclude Flag
N
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 71179-816-24 identifies a specific commercial package of 3 blister pack in 1 carton / 8 tablet, extended release in 1 blister pack of Naproxen Sodium And Pseudoephedrine Hydrochloride Cold And Sinus, a human over the counter drug labeled by Vespyr Brands Llc. This tablet, extended release is formulated for oral use and contains naproxen sodium; pseudoephedrine hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Vespyr Brands Llc on August 07, 2024. The current certification is valid through December 31, 2027.

How is this Vespyr Brands Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71179081624. 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)
71179-816-24
11-Digit CMS (5-4-2)
71179-0816-24

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