Methylphenidate Hydrochloride Capsule, Extended Release
NDC Package 0093-5347-01

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

Package Information

Methylphenidate Hydrochloride capsules is methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies (14)]. This formulation utilizes a capsule, extended release delivery system. Marketed by Teva Pharmaceuticals Usa, Inc., this product is identified by NDC 0093-5347 and is authorized under FDA application ANDA079031.

Identification & Billing

NDC Package Code
0093-5347-01
Package Description
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
0093-5347
11-Digit Billing Format
00093534701
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: 1806177 - methylphenidate HCl 20 MG 50/50 Release 24HR Extended Release Oral Capsule
  • RxCUI: 1806177 - 50/50 Release 24 HR methylphenidate hydrochloride 20 MG Extended Release Oral Capsule
  • RxCUI: 1806179 - methylphenidate HCl 30 MG 50/50 Release 24HR Extended Release Oral Capsule
  • RxCUI: 1806179 - 50/50 Release 24 HR methylphenidate hydrochloride 30 MG Extended Release Oral Capsule
  • RxCUI: 1806183 - methylphenidate HCl 40 MG 50/50 Release 24HR Extended Release Oral Capsule

Clinical Specifications

Proprietary Name
Methylphenidate Hydrochloride (la)
Non-Proprietary Name
Methylphenidate Hydrochloride
Substance Name
Methylphenidate Hydrochloride
Dosage Form
Capsule, Extended Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
METHYLPHENIDATE HYDROCHLORIDE 30 mg/1
Pharmacologic Class
Usage Information
Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies (14)].
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Teva Pharmaceuticals Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA079031
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-16-2012
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 0093-5347-01 identifies a specific commercial package of 100 capsule, extended release in 1 bottle of Methylphenidate Hydrochloride (la), a human prescription drug labeled by Teva Pharmaceuticals Usa, Inc.. This capsule, 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 Teva Pharmaceuticals Usa, Inc. on July 16, 2012. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00093534701. 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)
0093-5347-01
11-Digit CMS (5-4-2)
00093-5347-01

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