Focalin Capsule, Extended Release
NDC Package 66758-237-01

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

Package Information

Focalin (dexmethylphenidate hydrochloride) capsules is a medication used to treat attention deficit hyperactivity disorder - ADHD. This formulation utilizes a capsule, extended release delivery system. Marketed by Sandoz Inc, this product is identified by NDC 66758-237 and is authorized under FDA application NDA021802.

Identification & Billing

NDC Package Code
66758-237-01
Package Description
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
66758-237
11-Digit Billing Format
66758023701
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
  • RxCUI: 1006608 - dexmethylphenidate HCl 40 MG 24HR Extended Release Oral Capsule
  • RxCUI: 1006608 - 24 HR dexmethylphenidate hydrochloride 40 MG Extended Release Oral Capsule
  • RxCUI: 1006608 - dexmethylphenidate hydrochloride 40 MG 24 HR Extended Release Oral Capsule
  • RxCUI: 1006610 - Focalin XR 40 MG 24HR Extended Release Oral Capsule
  • RxCUI: 1006610 - 24 HR dexmethylphenidate hydrochloride 40 MG Extended Release Oral Capsule [Focalin]

Clinical Specifications

Proprietary Name
Focalin XR
Non-Proprietary Name
Dexmethylphenidate Hydrochloride
Substance Name
Dexmethylphenidate Hydrochloride
Dosage Form
Capsule, Extended Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DEXMETHYLPHENIDATE HYDROCHLORIDE 15 mg/1
Pharmacologic Class
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.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Sandoz Inc
Product Type
Human Prescription Drug
FDA Application #
NDA021802
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-31-2005
Listing Expiration
12-31-2026
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 66758-237-01 identifies a specific commercial package of 100 capsule, extended release in 1 bottle of Focalin XR, a human prescription drug labeled by Sandoz Inc. This capsule, extended release is formulated for oral use and contains dexmethylphenidate 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 Sandoz Inc on May 31, 2005. The current certification is valid through December 31, 2026.

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 Sandoz Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66758023701. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
66758-237-01
11-Digit CMS (5-4-2)
66758-0237-01

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