Aptensio Xr
NDC Package 42858-405-45

11-digit billing NDC: 42858040545 · Billing unit: EA · 90 EA per package
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 discontinued by the firm.

Aptensio Xr is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)]. Marketed by Rhodes Pharmaceuticals Llc, this product is identified by NDC 42858-405 and is authorized under FDA application NDA205831.

Identification & Billing

NDC Package Code
42858-405-45
Package Description
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code
42858-405
11-Digit Billing Format
42858040545
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
90 EA

Clinical Specifications

Proprietary Name
Aptensio Xr
Dosage Form
-
Usage Information
APTENSIO XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)].

Regulatory & Marketing

Labeler Name
Rhodes Pharmaceuticals Llc
FDA Application #
NDA205831
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-17-2015
End Marketing Date
05-20-2026
Listing Expiration
05-20-2026
Exclude Flag
D
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 42858-405-45 identifies a specific commercial package of 90 capsule, extended release in 1 bottle, plastic of Aptensio Xr, labeled by Rhodes Pharmaceuticals 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 Rhodes Pharmaceuticals Llc on April 17, 2015. The current certification is valid through May 20, 2026.

How is this Rhodes Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42858040545. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 90 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)
42858-405-45
11-Digit CMS (5-4-2)
42858-0405-45

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