Sinus And Cold D Tablet, Film Coated, Extended Release
NDC Package 51316-339-01

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

Package Information

Sinus And Cold D (naproxen sodium, pseudoephedrine hydrochloride) tablets is •do not take more than directed•the smallest effective dose should be used•swallow whole; do not crush or chew•drink a full glass of water with each dose•adults and children 12 years and older: 1 caplet every 12 hours; do not take more than 2 caplets in 24 hours•children under 12 years: do not use. This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Cvs Woonsocket Prescription Center, Incorporated, this product is identified by NDC 51316-339 and is authorized under FDA application ANDA076518.

Identification & Billing

NDC Package Code
51316-339-01
Package Description
20 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
51316-339
11-Digit Billing Format
51316033901
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
20 EA
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
Sinus And Cold D
Non-Proprietary Name
Naproxen Sodium, Pseudoephedrine Hydrochloride
Substance Name
Naproxen Sodium; Pseudoephedrine Hydrochloride
Dosage Form
Tablet, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
•do not take more than directed•the smallest effective dose should be used•swallow whole; do not crush or chew•drink a full glass of water with each dose•adults and children 12 years and older: 1 caplet every 12 hours; do not take more than 2 caplets in 24 hours•children under 12 years: do not use

Regulatory & Marketing

Labeler Name
Cvs Woonsocket Prescription Center, Incorporated
Product Type
Human Otc Drug
FDA Application #
ANDA076518
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-08-2024
Listing Expiration
12-31-2026
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 51316-339-01 identifies a specific commercial package of 20 blister pack in 1 carton / 1 tablet, film coated, extended release in 1 blister pack of Sinus And Cold D, a human over the counter drug labeled by Cvs Woonsocket Prescription Center, Incorporated. This product is billed for "EA" each discreet unit and contains an estimated amount of 20 billable units per package. This tablet, film coated, 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 Cvs Woonsocket Prescription Center, Incorporated on May 08, 2024. The current certification is valid through December 31, 2026.

How is this Cvs Woonsocket Prescription Center, Incorporated product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51316033901. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 20 total billable units per package. 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)
51316-339-01
11-Digit CMS (5-4-2)
51316-0339-01

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