Methylphenidate Hydrochloride Tablet
NDC Package 68084-823-21

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 is marked anxiety, tension, and agitation are contraindications to methylphenidate hydrochloride tablets and methylphenidate hydrochloride extended-release tablets, since the drug may aggravate these symptoms. This formulation utilizes a tablet delivery system. Marketed by American Health Packaging, this product is identified by NDC 68084-823 and is authorized under FDA application ANDA040300.

Identification & Billing

NDC Package Code
68084-823-21
Package Description
30 BLISTER PACK in 1 BOX, UNIT-DOSE / 1 TABLET in 1 BLISTER PACK (68084-823-11)
Product Code
68084-823
11-Digit Billing Format
68084082321
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
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 10 mg/1
Pharmacologic Class
Usage Information
Marked anxiety, tension, and agitation are contraindications to methylphenidate hydrochloride tablets and methylphenidate hydrochloride extended-release tablets, since the drug may aggravate these symptoms. Methylphenidate hydrochloride tablets and methylphenidate hydrochloride extended-release tablets are contraindicated also in patients known to be hypersensitive to the drug, in patients with glaucoma, and in patients with motor tics or with a family history or diagnosis of Tourette’s syndrome.Methylphenidate hydrochloride tablets and methylphenidate hydrochloride extended-release tablets are contraindicated during treatment with monoamine oxidase inhibitors, and also within a minimum of 14 days following discontinuation of a monoamine oxidase inhibitor (hypertensive crises may result).
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
American Health Packaging
Product Type
Human Prescription Drug
FDA Application #
ANDA040300
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-30-2014
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.

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Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68084-823-21 identifies a specific commercial package of 30 blister pack in 1 box, unit-dose / 1 tablet in 1 blister pack (68084-823-11) of Methylphenidate Hydrochloride, a human prescription drug labeled by American Health Packaging. 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 American Health Packaging on September 30, 2014. The current certification is valid through December 31, 2026.

How is this American Health Packaging product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68084082321. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
68084-823-21
11-Digit CMS (5-4-2)
68084-0823-21

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