Methamphetamine Hydrochloride Tablet
NDC Package 68308-115-01

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

Package Information

Methamphetamine Hydrochloride tablets is in patients known to be hypersensitive to amphetamine, or other components of methamphetamine hydrochloride tablets. This formulation utilizes a tablet delivery system. Marketed by Mayne Pharma Commercial Llc, this product is identified by NDC 68308-115 and is authorized under FDA application ANDA091189.

Identification & Billing

NDC Package Code
68308-115-01
Package Description
100 TABLET in 1 BOTTLE, PLASTIC
Product Code
68308-115
11-Digit Billing Format
68308011501
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Methamphetamine Hydrochloride
Non-Proprietary Name
Methamphetamine Hydrochloride
Substance Name
Methamphetamine 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)
METHAMPHETAMINE HYDROCHLORIDE 5 mg/1
Pharmacologic Class
Usage Information
In patients known to be hypersensitive to amphetamine, or other components of methamphetamine hydrochloride tablets. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products (see ADVERSE REACTIONS).Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk hypertensive crisis (see WARNINGS and DRUG INTERACTIONS). It is also contraindicated in patients with glaucoma, advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism or known hypersensitivity or idiosyncrasy to sympathomimetic amines. Methamphetamine should not be given to patients who are in an agitated state or who have a history of drug abuse.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Mayne Pharma Commercial Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA091189
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-26-2010
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 68308-115-01 identifies a specific commercial package of 100 tablet in 1 bottle, plastic of Methamphetamine Hydrochloride, a human prescription drug labeled by Mayne Pharma Commercial Llc. This tablet is formulated for oral use and contains methamphetamine 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 Mayne Pharma Commercial Llc on April 26, 2010. The current certification is valid through December 31, 2026.

How is this Mayne Pharma Commercial Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68308011501. 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)
68308-115-01
11-Digit CMS (5-4-2)
68308-0115-01

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