NDC Package 71179-816-24 Naproxen Sodium And Pseudoephedrine Hydrochloride Cold And Sinus

Naproxen Sodium And Pseudoephedrine Hydrochloride Tablet, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
71179-816-24
Package Description:
3 BLISTER PACK in 1 CARTON / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Product Code:
Proprietary Name:
Naproxen Sodium And Pseudoephedrine Hydrochloride Cold And Sinus
Non-Proprietary Name:
Naproxen Sodium And Pseudoephedrine Hydrochloride
Substance Name:
Naproxen Sodium; Pseudoephedrine Hydrochloride
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
11-Digit NDC Billing Format:
71179081624
NDC to 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
Product Type:
Human Otc Drug
Labeler Name:
Vespyr Brands, Inc.
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(s):
Oral - Administration to or by way of the mouth.
Sample Package:
No
FDA Application Number:
ANDA211360
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
08-07-2024
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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.

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Frequently Asked Questions

What is NDC 71179-816-24?

The NDC Packaged Code 71179-816-24 is assigned to a 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, Inc.. The product's dosage form is tablet, extended release and is administered via oral form.

Is NDC 71179-816 included in the NDC Directory?

Yes, Naproxen Sodium And Pseudoephedrine Hydrochloride Cold And Sinus with product code 71179-816 is active and included in the NDC Directory. The product was first marketed by Vespyr Brands, Inc. on August 07, 2024 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 71179-816-24?

The 11-digit format is 71179081624. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-271179-816-245-4-271179-0816-24