Sallus Pain Relief Collection With Naproxen
NDC Package 69036-221-15

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.

Sallus Pain Relief Collection With Naproxen is carefully consider the potential benefits and risks of naproxen, naproxen sodium and other treatment options before deciding to use naproxen or naproxen sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).Naproxen as naproxen tablets or naproxen sodium tablets are indicated:• For the relief of the signs and symptoms of rheumatoid arthritis• For the relief of the signs and symptoms of osteoarthritis• For the relief of the signs and symptoms of ankylosing spondylitis• For the relief of the signs and symptoms of juvenile arthritisNaproxen as naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient’s weight.Naproxen as naproxen tablets and naproxen sodium tablets are also indicated:• For relief of the signs and symptoms of tendonitis• For relief of the signs and symptoms of bursitis• For relief of the signs and symptoms of acute gout• For the management of pain• For the management of primary dysmenorrhea. Marketed by Sallus Laboratories, Llc, this product is identified by NDC 69036-221 and is authorized under FDA application ANDA078250.

Identification & Billing

NDC Package Code
69036-221-15
Package Description
1 KIT in 1 CARTON * 30 TABLET in 1 BOTTLE (69036-220-30) * 60 mL in 1 BOTTLE, PLASTIC
Product Code
69036-221
11-Digit Billing Format
69036022115
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk
RxCUI: 198014 - naproxen 500 MG Oral Tablet

Clinical Specifications

Proprietary Name
Sallus Pain Relief Collection With Naproxen
Dosage Form
-
Usage Information
Carefully consider the potential benefits and risks of naproxen, naproxen sodium and other treatment options before deciding to use naproxen or naproxen sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).Naproxen as naproxen tablets or naproxen sodium tablets are indicated:• For the relief of the signs and symptoms of rheumatoid arthritis• For the relief of the signs and symptoms of osteoarthritis• For the relief of the signs and symptoms of ankylosing spondylitis• For the relief of the signs and symptoms of juvenile arthritisNaproxen as naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient’s weight.Naproxen as naproxen tablets and naproxen sodium tablets are also indicated:• For relief of the signs and symptoms of tendonitis• For relief of the signs and symptoms of bursitis• For relief of the signs and symptoms of acute gout• For the management of pain• For the management of primary dysmenorrhea

Regulatory & Marketing

Labeler Name
Sallus Laboratories, Llc
FDA Application #
ANDA078250
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-01-2007
Listing Expiration
12-31-2017
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 69036-221-15 identifies a specific commercial package of 1 kit in 1 carton * 30 tablet in 1 bottle (69036-220-30) * 60 ml in 1 bottle, plastic of Sallus Pain Relief Collection With Naproxen, labeled by Sallus Laboratories, 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 Sallus Laboratories, Llc on July 01, 2007. The current certification is valid through December 31, 2017.

How is this Sallus Laboratories, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69036022115. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
69036-221-15
11-Digit CMS (5-4-2)
69036-0221-15

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