1. Home
  2. Labeler Index
  3. American Regent, Inc.
  4. NDC Product Code: 0517-5601 Hydroxyzine Hydrochloride

NDC 0517-5601 Hydroxyzine Hydrochloride

Injection, Solution Intramuscular - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 0517-5601?
  4. Hydroxyzine Hydrochloride Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes

Product Information

NDC Product Code:
0517-5601
Proprietary Name:
Hydroxyzine Hydrochloride
Non-Proprietary Name: [1]
Hydroxyzine Hydrochloride
Substance Name: [2]
Hydroxyzine Dihydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s): [4]
  • Intramuscular - Administration within a muscle.
    • Labeler Name: [5]
    American Regent, Inc.
    Labeler Code:
    0517
    Product Label ID:
    8af7e5ce-d9d9-44cc-9f2f-4ddbc89e758a
    FDA Application Number: [6]
    ANDA087408
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    09-30-1990
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0517-5601-25

    Package Description: 25 VIAL, SINGLE-DOSE in 1 TRAY / 1 mL in 1 VIAL, SINGLE-DOSE

    Product Details

    What is NDC 0517-5601?

    The NDC code 0517-5601 is assigned by the FDA to the product Hydroxyzine Hydrochloride which is a human prescription drug product labeled by American Regent, Inc.. The product's dosage form is injection, solution and is administered via intramuscular form. The product is distributed in a single package with assigned NDC code 0517-5601-25 25 vial, single-dose in 1 tray / 1 ml in 1 vial, single-dose. 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 Hydroxyzine Hydrochloride?

    The total management of anxiety, tension, and psychomotor agitation in conditions of emotional stress requires in most instances a combined approach of psychotherapy and chemotherapy. Hydroxyzine has been found to be particularly useful for this latter phase of therapy in its ability to render the disturbed patient more amenable to psychotherapy in long term treatment of the psychoneurotic and psychotic, although it should not be used as the sole treatment of psychosis or of clearly demonstrated cases of depression.Hydroxyzine is also useful in alleviating the manifestations of anxiety and tension as in the preparation for dental procedures and in acute emotional problems. It has also been recommended for the management of anxiety associated with organic disturbances and as adjunctive therapy in alcoholism and allergic conditions with strong emotional overlay, such as in asthma, chronic urticaria, and pruritus.Hydroxyzine hydrochloride intramuscular solution is useful in treating the following types of patients when intramuscular administration is indicated:1. The acutely disturbed or hysterical patient.2. The acute or chronic alcoholic with anxiety withdrawal symptoms or delirium tremens.3. As pre-and postoperative and pre- and postpartum adjunctive medication to permit reduction in narcotic dosage, allay anxiety and control emesis.Hydroxyzine hydrochloride has also demonstrated effectiveness in controlling nausea and vomiting, excluding nausea and vomiting of pregnancy. (See CONTRAINDICATIONS).In prepartum states, the reduction in narcotic requirement effected by hydroxyzine is of particular benefit to both mother and neonate.Hydroxyzine benefits the cardiac patient by its ability to allay the associated anxiety and apprehension attendant to certain types of heart disease. Hydroxyzine is not known to interfere with the action of digitalis in any way and may be used concurrently with this agent.The effectiveness of hydroxyzine in long term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.

    What are Hydroxyzine 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.
    • HYDROXYZINE DIHYDROCHLORIDE 50 mg/mL - A histamine H1 receptor antagonist that is effective in the treatment of chronic urticaria, dermatitis, and histamine-mediated pruritus. Unlike its major metabolite CETIRIZINE, it does cause drowsiness. It is also effective as an antiemetic, for relief of anxiety and tension, and as a sedative.

    Which are Hydroxyzine Hydrochloride UNII Codes?

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

    Which are Hydroxyzine 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:

    What is the NDC to RxNorm Crosswalk for Hydroxyzine Hydrochloride?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

    Which are the Pharmacologic Classes for Hydroxyzine 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.

    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.

    [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".