Methylphenidate Hydrochloride Capsule, Extended Release
NDC Package 0591-3902-19

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

Package Information

Methylphenidate Hydrochloride capsules is methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)].Limitations of UsePediatric patients younger than 6 years of age experienced higher plasma exposure than patients 6 years and older at the same dose and high rates of adverse reactions, most notably weight loss [see Use in Specific Populations (8.4)]. This formulation utilizes a capsule, extended release delivery system. Marketed by Actavis Pharma, Inc., this product is identified by NDC 0591-3902 and is authorized under FDA application ANDA208861.

Identification & Billing

NDC Package Code
0591-3902-19
Package Description
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
0591-3902
11-Digit Billing Format
00591390219
RxNorm Crosswalk
  • RxCUI: 1648183 - methylphenidate HCl 15 MG 40/60 Release 24HR Extended Release Oral Capsule
  • RxCUI: 1648183 - 40/60 Release 24 HR methylphenidate hydrochloride 15 MG Extended Release Oral Capsule
  • RxCUI: 1806200 - methylphenidate HCl 10 MG 40/60 Release 24HR Extended Release Oral Capsule
  • RxCUI: 1806200 - 40/60 Release 24 HR methylphenidate hydrochloride 10 MG Extended Release Oral Capsule
  • RxCUI: 1806202 - methylphenidate HCl 20 MG 40/60 Release 24HR Extended Release Oral Capsule

Clinical Specifications

Proprietary Name
Methylphenidate Hydrochloride
Non-Proprietary Name
Methylphenidate Hydrochloride
Substance Name
Methylphenidate 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)
METHYLPHENIDATE HYDROCHLORIDE 60 mg/1
Pharmacologic Class
Usage Information
Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)].Limitations of UsePediatric patients younger than 6 years of age experienced higher plasma exposure than patients 6 years and older at the same dose and high rates of adverse reactions, most notably weight loss [see Use in Specific Populations (8.4)].
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Actavis Pharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA208861
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-30-2020
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 0591-3902-19 identifies a specific commercial package of 90 capsule, extended release in 1 bottle of Methylphenidate Hydrochloride, a human prescription drug labeled by Actavis Pharma, Inc.. This capsule, extended release is formulated for oral use and contains methylphenidate 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 Actavis Pharma, Inc. on September 30, 2020. The current certification is valid through December 31, 2026.

How is this Actavis Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00591390219. 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)
0591-3902-19
11-Digit CMS (5-4-2)
00591-3902-19

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