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  5. NDC Package Code: 68308-115-01 Methamphetamine Hydrochloride

NDC Package 68308-115-01 Methamphetamine Hydrochloride

Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
68308-115-01
Package Description:
100 TABLET in 1 BOTTLE, PLASTIC
Product Code:
68308-115
Proprietary Name:
Methamphetamine Hydrochloride
Non-Proprietary Name:
Methamphetamine Hydrochloride
Substance Name:
Methamphetamine Hydrochloride
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.
11-Digit NDC Billing Format:
68308011501
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
100 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 977860 - methamphetamine HCl 5 MG Oral Tablet
  • RxCUI: 977860 - methamphetamine hydrochloride 5 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Mayne Pharma Commercial Llc
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • METHAMPHETAMINE HYDROCHLORIDE 5 mg/1
    • Pharmacologic Class(es):
  • Amphetamine Anorectic - [EPC] (Established Pharmacologic Class)
  • Amphetamines - [CS]
  • Appetite Suppression - [PE] (Physiologic Effect)
  • Central Nervous System Stimulant - [EPC] (Established Pharmacologic Class)
  • Central Nervous System Stimulation - [PE] (Physiologic Effect)
  • Increased Sympathetic Activity - [PE] (Physiologic Effect)
    • DEA Schedule:
    Schedule II (CII) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA091189
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-26-2010
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 68308-115-01?

    The NDC Packaged Code 68308-115-01 is assigned to a package of 100 tablet in 1 bottle, plastic of Methamphetamine Hydrochloride, a human prescription drug labeled by Mayne Pharma Commercial Llc. The product's dosage form is tablet and is administered via oral form.

    Is NDC 68308-115 included in the NDC Directory?

    Yes, Methamphetamine Hydrochloride with product code 68308-115 is active and included in the NDC Directory. The product was first marketed by Mayne Pharma Commercial Llc on April 26, 2010 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 68308-115-01?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 100.

    What is the 11-digit format for NDC 68308-115-01?

    The 11-digit format is 68308011501. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-268308-115-015-4-268308-0115-01