Methylphenidate Hydrochloride Capsule, Extended Release
NDC Package 42858-080-45

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 is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)]. This formulation utilizes a capsule, extended release delivery system. Marketed by Rhodes Pharmaceuticals Llc, this product is identified by NDC 42858-080 and is authorized under FDA application NDA205831.

Identification & Billing

NDC Package Code
42858-080-45
Package Description
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
42858-080
11-Digit Billing Format
42858008045
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
90 EA
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 50 mg/1
Pharmacologic Class
Usage Information
Methylphenidate Hydrochloride Extended-Release Capsules is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)].
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Rhodes Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
NDA205831
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
04-01-2020
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 42858-080-45 identifies a specific commercial package of 90 capsule, extended release in 1 bottle of Methylphenidate Hydrochloride, a human prescription drug labeled by Rhodes Pharmaceuticals Llc. 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 Rhodes Pharmaceuticals Llc on April 01, 2020. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42858008045. 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)
42858-080-45
11-Digit CMS (5-4-2)
42858-0080-45

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