Focalin
NDC Package 16590-649-30

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Focalin is a medication used to treat attention deficit hyperactivity disorder - ADHD. Marketed by Stat Rx Usa Llc, this product is identified by NDC 16590-649 and is authorized under FDA application NDA021802.

Identification & Billing

NDC Package Code
16590-649-30
Package Description
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
16590-649
11-Digit Billing Format
16590064930
RxNorm Crosswalk
  • RxCUI: 899461 - dexmethylphenidate HCl 15 MG 24HR Extended Release Oral Capsule
  • RxCUI: 899461 - 24 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral Capsule
  • RxCUI: 899461 - dexmethylphenidate hydrochloride 15 MG 24 HR Extended Release Oral Capsule
  • RxCUI: 899463 - Focalin XR 15 MG 24HR Extended Release Oral Capsule
  • RxCUI: 899463 - 24 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral Capsule [Focalin]

Clinical Specifications

Proprietary Name
Focalin XR
Dosage Form
-
Usage Information
This medication is used to treat attention deficit hyperactivity disorder - ADHD. It works by changing the amounts of certain natural substances in the brain. Dexmethylphenidate belongs to a class of drugs known as stimulants. It can help increase your ability to pay attention, stay focused on an activity, and control behavior problems. It may also help you to organize your tasks and improve listening skills.

Regulatory & Marketing

Labeler Name
Stat Rx Usa Llc
FDA Application #
NDA021802
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-31-2005
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (16590-649). Click a package code to view its specific billing and regulatory data.

16590-649-60
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
16590-649-90
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

* 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 16590-649-30 identifies a specific commercial package of 30 capsule, extended release in 1 bottle of Focalin XR, labeled by Stat Rx Usa 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 Stat Rx Usa Llc on May 31, 2005. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

This medication is used to treat attention deficit hyperactivity disorder - ADHD. It works by changing the amounts of certain natural substances in the brain. Dexmethylphenidate belongs to a class of drugs known as stimulants. It can help increase your ability to pay attention, stay focused on an activity, and control behavior problems. It may also help you to organize your tasks and improve listening skills.

How is this Stat Rx Usa Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16590064930. 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)
16590-649-30
11-Digit CMS (5-4-2)
16590-0649-30

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