Dexmethylphenidate Hydrochloride Capsule, Extended Release
NDC Package 0781-2732-31

11-digit billing NDC: 00781273231
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Dexmethylphenidate Hydrochloride capsules is dexmethylphenidate hydrochloride extended-release capsules is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)].Limitations of UseThe use of dexmethylphenidate hydrochloride extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)]. This formulation utilizes a capsule, extended release delivery system. Marketed by Sandoz Inc, this product is identified by NDC 0781-2732 and is authorized under FDA application NDA021802.

Identification & Billing

NDC Package Code
0781-2732-31
Package Description
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
0781-2732
11-Digit Billing Format
00781273231

Clinical Specifications

Proprietary Name
Dexmethylphenidate Hydrochloride Extended-release
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 30 mg/1
Pharmacologic Class
Usage Information
Dexmethylphenidate hydrochloride extended-release capsules is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)].Limitations of UseThe use of dexmethylphenidate hydrochloride extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Sandoz Inc
Product Type
Human Prescription Drug
FDA Application #
NDA021802
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
10-01-2026
Listing Expiration
12-31-2027
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 0781-2732-31 identifies a specific commercial package of 30 capsule, extended release in 1 bottle of Dexmethylphenidate Hydrochloride Extended-release, 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 October 01, 2026. The current certification is valid through December 31, 2027.

How is this Sandoz Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00781273231. 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)
0781-2732-31
11-Digit CMS (5-4-2)
00781-2732-31

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