Methylphenidate Hydrochloride
NDC Package 65580-532-01

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.

Methylphenidate Hydrochloride is marked anxiety, tension, and agitation are contraindications to methylphenidate, since the drug may aggravate these symptoms. Marketed by Upstate Pharma, Llc, this product is identified by NDC 65580-532 and is authorized under FDA application ANDA086428.

Identification & Billing

NDC Package Code
65580-532-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
65580-532
11-Digit Billing Format
65580053201
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Methylphenidate Hydrochloride
Dosage Form
-
Usage Information
Marked anxiety, tension, and agitation are contraindications to methylphenidate, since the drug may aggravate these symptoms. Methylphenidate is contraindicated also in patients known to be hypersensitive to the drug, in patients with glaucoma, and in patients with motor tics or with a family history or diagnosis of Tourette's syndrome.Methylphenidate is contraindicated during treatment with monoamine oxidase inhibitors, and also within a minimum of 14 days following discontinuation of a monoamine oxidase inhibitor (hypertensive crises may result).

Regulatory & Marketing

Labeler Name
Upstate Pharma, Llc
FDA Application #
ANDA086428
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 65580-532-01 identifies a specific commercial package of 100 tablet in 1 bottle of Methylphenidate Hydrochloride, 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.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65580053201. 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)
65580-532-01
11-Digit CMS (5-4-2)
65580-0532-01

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