Methylphenidate Hydrochloride Tablet, Extended Release
NDC Package 70010-042-01

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 tablets is methylphenidate hydrochloride extended-release 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, extended release delivery system. Marketed by Granules Pharmaceuticals Inc., this product is identified by NDC 70010-042 and is authorized under FDA application ANDA210992.

Identification & Billing

NDC Package Code
70010-042-01
Package Description
100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code
70010-042
11-Digit Billing Format
70010004201
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
  • RxCUI: 1091145 - methylphenidate HCl 10 MG 8HR Extended Release Oral Tablet
  • RxCUI: 1091145 - 8 HR methylphenidate hydrochloride 10 MG Extended Release Oral Tablet
  • RxCUI: 1091145 - methylphenidate HCl 10 MG 8 HR Extended Release Oral Tablet
  • RxCUI: 1091225 - methylphenidate HCl 20 MG 8HR Extended Release Oral Tablet
  • RxCUI: 1091225 - 8 HR methylphenidate hydrochloride 20 MG Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Methylphenidate Hydrochloride
Non-Proprietary Name
Methylphenidate Hydrochloride
Substance Name
Methylphenidate Hydrochloride
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
METHYLPHENIDATE HYDROCHLORIDE 10 mg/1
Pharmacologic Class
Usage Information
Methylphenidate hydrochloride extended-release 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
Granules Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA210992
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-17-2018
Listing Expiration
12-31-2027
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 (70010-042). Click a package code to view its specific billing and regulatory data.

70010-042-03
30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

* 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 70010-042-01 identifies a specific commercial package of 100 tablet, extended release in 1 bottle, plastic of Methylphenidate Hydrochloride, a human prescription drug labeled by Granules Pharmaceuticals Inc.. This tablet, extended release 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 Granules Pharmaceuticals Inc. on December 17, 2018. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70010004201. 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)
70010-042-01
11-Digit CMS (5-4-2)
70010-0042-01

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