Ritalin
NDC Package 0078-0442-05

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 discontinued by the firm.

Ritalin is a medication used to treat attention deficit hyperactivity disorder - ADHD. Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-0442 and is authorized under FDA application NDA018029.

Identification & Billing

NDC Package Code
0078-0442-05
Package Description
100 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
0078-0442
11-Digit Billing Format
00078044205
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA

Clinical Specifications

Proprietary Name
Ritalin SR
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
Novartis Pharmaceuticals Corporation
FDA Application #
NDA018029
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-31-1982
End Marketing Date
12-27-2018
Listing Expiration
12-27-2018
Exclude Flag
D
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 0078-0442-05 identifies a specific commercial package of 100 tablet, extended release in 1 bottle of Ritalin SR, labeled by Novartis Pharmaceuticals Corporation. 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 Novartis Pharmaceuticals Corporation on March 31, 1982. The current certification is valid through December 27, 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 Novartis Pharmaceuticals Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078044205. 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 (4-4-2)
0078-0442-05
11-Digit CMS (5-4-2)
00078-0442-05

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