Methylphenidate Hydrochloride Tablet
NDC Package 16729-478-01

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

Package Information

Methylphenidate Hydrochloride tablets are indicated for the treatment of:Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adultsNarcolepsy. This formulation utilizes a tablet delivery system. Marketed by Accord Healthcare, Inc., this product is identified by NDC 16729-478 and is authorized under FDA application ANDA213936.

Identification & Billing

NDC Package Code
16729-478-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
16729-478
11-Digit Billing Format
16729047801
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Methylphenidate Hydrochloride
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
Methylphenidate hydrochloride tablets are indicated for the treatment of:Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adultsNarcolepsy
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Accord Healthcare, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA213936
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-23-2020
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 16729-478-01 identifies a specific commercial package of 100 tablet in 1 bottle of Methylphenidate Hydrochloride, a human prescription drug labeled by Accord Healthcare, Inc.. 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 Accord Healthcare, Inc. on December 23, 2020. The current certification is valid through December 31, 2026.

How is this Accord Healthcare, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16729047801. 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)
16729-478-01
11-Digit CMS (5-4-2)
16729-0478-01

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