1. Labeler Index
  2. Hikma Pharmaceuticals Usa Inc.
  3. NDC Product Code: 0054-0389 Methamphetamine Hydrochloride

NDC 0054-0389 Methamphetamine Hydrochloride

Tablet Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

    1. Product Information
    2. Product Packages
    3. Product Characteristics
    4. What is NDC 0054-0389?
    5. Methamphetamine Hydrochloride Uses
    6. Active Ingredients
    7. Active Ingredients UNII Codes
    8. Inactive Ingredients UNII Codes
    9. Pharmacologic Classes
    10. Patient Education

Product Information

NDC Product Code:
0054-0389
Proprietary Name:
Methamphetamine Hydrochloride
Non-Proprietary Name: [1]
Methamphetamine Hydrochloride
Substance Name: [2]
Methamphetamine Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Hikma Pharmaceuticals Usa Inc.
    Labeler Code:
    0054
    Product Label ID:
    90c02ac6-e5e2-4c97-8c68-81e4e389a195
    FDA Application Number: [6]
    ANDA203846
    DEA Schedule: [7]
    Schedule II (CII) Substances
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    12-06-2016
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325)
    Shape:
    ROUND (C48348)
    Size(s):
    6 MM
    Imprint(s):
    54;681
    Score:
    1

    Product Packages

    NDC Code 0054-0389-25

    Package Description: 100 TABLET in 1 BOTTLE

    Price per Unit: $6.82872 per EA

    Product Details

    What is NDC 0054-0389?

    The NDC code 0054-0389 is assigned by the FDA to the product Methamphetamine Hydrochloride which is a human prescription drug product labeled by Hikma Pharmaceuticals Usa Inc.. The product's dosage form is tablet and is administered via oral form. The product is distributed in a single package with assigned NDC code 0054-0389-25 100 tablet in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Methamphetamine Hydrochloride?

    Methamphetamine is contraindicated during or within 14 days following the administration of monoamine oxidase inhibitors; hypertensive crisis may result. 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.

    What are Methamphetamine Hydrochloride Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • METHAMPHETAMINE HYDROCHLORIDE 5 mg/1 - A central nervous system stimulant and sympathomimetic with actions and uses similar to DEXTROAMPHETAMINE. The smokable form is a drug of abuse and is referred to as crank, crystal, crystal meth, ice, and speed.

    Which are Methamphetamine Hydrochloride UNII Codes?

    The UNII codes for the active ingredients in this product are:

    • METHAMPHETAMINE HYDROCHLORIDE (UNII: 997F43Z9CV)
    • METHAMPHETAMINE (UNII: 44RAL3456C) (Active Moiety)

    Which are Methamphetamine Hydrochloride Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    Which are the Pharmacologic Classes for Methamphetamine Hydrochloride?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Methamphetamine


    Methamphetamine is used as part of a treatment program to control symptoms of attention deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age) in children. Methamphetamine is also used for a limited period of time (a few weeks) along with a reduced calorie diet and an exercise plan for weight loss in obese people unable to lose weight. Methamphetamine is in a class of medications called central nervous system stimulants. It works by changing the amounts of certain natural substances in the brain.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [7] What is the Drug Enforcement Administration (DEA) CII Schedule? - This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".