Methylphenidate Hydrochloride Solution
NDC Package 43602-178-25

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

Package Information

Methylphenidate Hydrochloride solution is a medication used to treat attention deficit hyperactivity disorder - ADHD. This formulation utilizes a solution delivery system. Marketed by Ascent Pharmaceuticals, Inc., this product is identified by NDC 43602-178 and is authorized under FDA application ANDA207417.

Identification & Billing

NDC Package Code
43602-178-25
Package Description
250 mL in 1 BOTTLE
Product Code
43602-178
11-Digit Billing Format
43602017825
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Methylphenidate Hydrochloride
Non-Proprietary Name
Methylphenidate Hydrochloride
Substance Name
Methylphenidate
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
METHYLPHENIDATE 10 mg/5mL
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.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Ascent Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA207417
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-29-2021
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (43602-178). Click a package code to view its specific billing and regulatory data.

43602-178-05
500 mL in 1 BOTTLE

* 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 43602-178-25 identifies a specific commercial package of 250 ml in 1 bottle of Methylphenidate Hydrochloride, a human prescription drug labeled by Ascent Pharmaceuticals, Inc.. This solution is formulated for oral use and contains methylphenidate 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 Ascent Pharmaceuticals, Inc. on January 29, 2021. The current certification is valid through December 31, 2026.

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.

How is this Ascent Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43602017825. 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)
43602-178-25
11-Digit CMS (5-4-2)
43602-0178-25

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