Ritalin Tablet
NDC Package 0078-0439-05

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 approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Ritalin (methylphenidate hydrochloride) tablets is a medication used to treat attention deficit hyperactivity disorder - ADHD. This formulation utilizes a tablet delivery system. Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-0439 and is authorized under FDA application NDA010187.

Identification & Billing

NDC Package Code
0078-0439-05
Package Description
100 TABLET in 1 BOTTLE
Product Code
0078-0439
11-Digit Billing Format
00078043905
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
Ritalin
Non-Proprietary Name
Methylphenidate Hydrochloride
Substance Name
Methylphenidate Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
METHYLPHENIDATE HYDROCHLORIDE 5 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. This medication is also used to treat a certain sleep disorder (narcolepsy).
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Novartis Pharmaceuticals Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA010187
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-31-1955
End Marketing Date
08-31-2026
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 0078-0439-05 identifies a specific commercial package of 100 tablet in 1 bottle of Ritalin, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. This tablet 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 Novartis Pharmaceuticals Corporation on December 31, 1955.

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: 00078043905. 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)
0078-0439-05
11-Digit CMS (5-4-2)
00078-0439-05

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