Aleve-d Sinus And Headache Tablet
NDC Package 0280-6045-10

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

Package Information

Aleve-d Sinus And Headache (naproxen sodium, pseudoephedrine hydrochloride) tablets is uses temporarily relieves these cold, sinus, and flu symptoms: • sinus pressure • minor body aches and pains • headache • nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose) • fever. This formulation utilizes a tablet delivery system. Marketed by Bayer Healthcare Llc., this product is identified by NDC 0280-6045 and is authorized under FDA application ANDA076518.

Identification & Billing

NDC Package Code
0280-6045-10
Package Description
1 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK
Product Code
0280-6045
11-Digit Billing Format
00280604510
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
Aleve-d Sinus And Headache
Non-Proprietary Name
Naproxen Sodium, Pseudoephedrine Hydrochloride
Substance Name
Naproxen Sodium; Pseudoephedrine Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Uses temporarily relieves these cold, sinus, and flu symptoms: • sinus pressure • minor body aches and pains • headache • nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose) • fever

Regulatory & Marketing

Labeler Name
Bayer Healthcare Llc.
Product Type
Human Otc Drug
FDA Application #
ANDA076518
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-01-2014
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 0280-6045-10 identifies a specific commercial package of 1 blister pack in 1 carton / 10 tablet in 1 blister pack of Aleve-d Sinus And Headache, a human over the counter drug labeled by Bayer Healthcare Llc.. This tablet 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 Bayer Healthcare Llc. on January 01, 2014. The current certification is valid through December 31, 2026.

How is this Bayer Healthcare Llc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00280604510. 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 (4-4-2)
0280-6045-10
11-Digit CMS (5-4-2)
00280-6045-10

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