Metadate Cd Capsule, Extended Release
NDC Package 69654-583-30

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

Package Information

Metadate Cd (methylphenidate hydrochloride) capsules is a medication used to treat attention deficit hyperactivity disorder - ADHD. This formulation utilizes a capsule, extended release delivery system. Marketed by Aytu Biopharma, Inc., this product is identified by NDC 69654-583 and is authorized under FDA application NDA021259.

Identification & Billing

NDC Package Code
69654-583-30
Package Description
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
69654-583
11-Digit Billing Format
69654058330
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
  • RxCUI: 1091139 - Metadate CD 10 MG 24HR Extended Release Oral Capsule
  • RxCUI: 1091139 - 30/70 Release 24 HR methylphenidate hydrochloride 10 MG Extended Release Oral Capsule [Metadate]
  • RxCUI: 1091139 - Metadate CD 10 MG 24 HR Extended Release Oral Capsule
  • RxCUI: 1091163 - Metadate CD 20 MG 24HR Extended Release Oral Capsule
  • RxCUI: 1091163 - 30/70 Release 24 HR methylphenidate hydrochloride 20 MG Extended Release Oral Capsule [Metadate]

Clinical Specifications

Proprietary Name
Metadate Cd
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
This medication is used to treat attention deficit hyperactivity disorder - ADHD. It works by changing the amounts of certain natural substances in the brain. Methylphenidate 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
Aytu Biopharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA021259
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-22-2024
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 69654-583-30 identifies a specific commercial package of 30 capsule, extended release in 1 bottle of Metadate Cd, a human prescription drug labeled by Aytu Biopharma, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. 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 Aytu Biopharma, Inc. on February 22, 2024. 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. Methylphenidate 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 Aytu Biopharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69654058330. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
69654-583-30
11-Digit CMS (5-4-2)
69654-0583-30

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