Metadate Er
NDC Package 65580-594-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Metadate Er is a medication used to treat attention deficit hyperactivity disorder - ADHD. Marketed by Upstate Pharma, Llc, this product is identified by NDC 65580-594 and is authorized under FDA application ANDA089601.

Identification & Billing

NDC Package Code
65580-594-01
Package Description
100 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
65580-594
11-Digit Billing Format
65580059401
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: 1091225 - methylphenidate HCl 20 MG 8HR Extended Release Oral Tablet
  • RxCUI: 1091225 - 8 HR methylphenidate hydrochloride 20 MG Extended Release Oral Tablet
  • RxCUI: 1091225 - methylphenidate HCl 20 MG 8 HR Extended Release Oral Tablet
  • RxCUI: 1091488 - Metadate ER 20 MG 8HR Extended Release Oral Tablet
  • RxCUI: 1091488 - 8 HR methylphenidate hydrochloride 20 MG Extended Release Oral Tablet [Metadate]

Clinical Specifications

Proprietary Name
Metadate Er
Dosage Form
-
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. This medication is also used to treat a certain sleep disorder (narcolepsy).

Regulatory & Marketing

Labeler Name
Upstate Pharma, Llc
FDA Application #
ANDA089601
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-01-2014
Listing Expiration
12-31-2018
Exclude Flag
I
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 65580-594-01 identifies a specific commercial package of 100 tablet, extended release in 1 bottle of Metadate Er, labeled by Upstate Pharma, Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Upstate Pharma, Llc on November 01, 2014. The current certification is valid through December 31, 2018.

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. This medication is also used to treat a certain sleep disorder (narcolepsy).

How is this Upstate Pharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65580059401. 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)
65580-594-01
11-Digit CMS (5-4-2)
65580-0594-01

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