Hydroxyzine Hydrochloride
Henry Schein, Inc.
Human Prescription Drug
NDC 0404-9877Hydroxyzine Hydrochloride is a human prescription drug labeled by 'Henry Schein, Inc.'. National Drug Code (NDC) number for Hydroxyzine Hydrochloride is 0404-9877. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Hydroxyzine Hydrochloride drug includes Hydroxyzine Dihydrochloride - 50 mg/mL . The currest status of Hydroxyzine Hydrochloride drug is Active.
Drug Information:
| Drug NDC: | 0404-9877 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Hydroxyzine Hydrochloride |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Hydroxyzine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Henry Schein, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection, Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | HYDROXYZINE DIHYDROCHLORIDE - 50 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAMUSCULAR
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 17 Jan, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 17 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA087408 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Henry Schein, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1794554
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| UNII: | 76755771U3
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Antihistamine [EPC]
Histamine Receptor Antagonists [MoA]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0404-9877-01 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9877-01) / 1 mL in 1 VIAL, SINGLE-DOSE | 17 Jan, 2022 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Hydroxyzine hydrochloride hydroxyzine hydrochloride hydroxyzine dihydrochloride hydroxyzine hydrochloric acid sodium hydroxide
Indications and Usage:
Indications and usage 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
Read more...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.
Warnings:
Warnings tissue damage: intramuscular hydroxyzine hydrochloride may result in severe injection site reactions (including extensive tissue damage, necrosis and gangrene) requiring surgical intervention (including debridement, skin grafting and amputation).
Dosage and Administration:
Dosage and administration the recommended dosages for hydroxyzine hydrochloride intramuscular solution are: as with all potent medications, the dosage should be adjusted according to the patient's response to therapy. for additional information on the administration and site of selection see precautions section. note: hydroxyzine hydrochloride intramuscular solution may be administered without further dilution. patients may be started on intramuscular therapy when indicated. they should be maintained on oral therapy whenever this route is practicable. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. image1.jpg
Contraindications:
Contraindications hydroxyzine hydrochloride intramuscular solution is intended only for intramuscular administration and should not, under any circumstances, be injected subcutaneously, intra arterially or intravenously. hydroxyzine is contraindicated in patients with a prolonged qt interval. this drug is contraindicated for patients who have shown a previous hypersensitivity to it. hydroxyzine, when administered to the pregnant mouse, rat, and rabbit, induced fetal abnormalities in the rat at doses substantially above the human therapeutic range. clinical data in human beings are inadequate to establish safety in early pregnancy. until such data are available, hydroxyzine is contraindicated in early pregnancy.
Adverse Reactions:
Adverse reactions therapeutic doses of hydroxyzine seldom produce impairment of mental alertness. however, drowsiness may occur; if so, it is usually transitory and may disappear in a few days of continued therapy or upon reduction of the dose. dryness of the mouth may be encountered at higher doses. extensive clinical use has substantiated the absence of toxic effects on the liver or bone marrow when administered in the recommended doses for over four years of uninterrupted therapy. the absence of adverse effects has been further demonstrated in experimental studies in which excessively high doses were administered. involuntary motor activity, including rare instances of tremor and convulsions, has been reported, usually with doses considerably higher than those recommended. continuous therapy with over one gram per day has been employed in some patients without these effects having been encountered. hydroxyzine hydrochloride is associated with acute generalized exanthematous pustulos
Read more...is (agep) in post marketing reports.
Description:
Description hydroxyzine hydrochloride has the chemical name of (±)-2-[2-[4-(p-chloro-a phenylbenzyl) -1-piperazinyl]ethoxy]ethanol dihydrochloride and occurs as a white, odorless powder which is very soluble in water. it has the following structural formula: molecular formula: c21h27cin202â¢2hci molecular weight: 447.83 hydroxyzine hydrochloride injection, usp is a sterile aqueous solution intended for intramuscular administration. each ml contains: hydroxyzine hci 25 mg or 50 mg, benzyl alcohol 0.9%, and water for injection q.s. ph adjusted with sodium hydroxide and/or hydrochloric acid. formula1.jpg
Clinical Pharmacology:
Clinical pharmacology hydroxyzine hydrochloride is unrelated chemically to phenothiazine, reserpine, and meprobamate. hydroxyzine has demonstrated its clinical effectiveness in the chemotherapeutic aspect of the total management of neuroses and emotional disturbances manifested by anxiety, tension, agitation, apprehension or confusion. hydroxyzine has been shown clinically to be a rapid-acting true ataraxic with a wide margin of safety. it induces a calming effect in anxious, tense, psychoneurotic adults and also in anxious, hyperkinetic children without impairing mental alertness. it is not a cortical depressant, but its action may be due to a suppression of activity in certain key regions of the subcortical area of the central nervous system. primary skeletal muscle relaxation has been demonstrated experimentally. hydroxyzine has been shown experimentally to have antispasmodic properties, apparently mediated through interference with the mechanism that responds to spasmogenic agents
Read more...such as serotonin, acetylcholine, and histamine. antihistaminic effects have been demonstrated experimentally and confirmed clinically. an antiemetic effect, both by the apomorphine test and the veriloid test, has been demonstrated. pharmacological and clinical studies indicate that hydroxyzine in therapeutic dosage does not increase gastric secretion or acidity and in most cases provides mild antisecretory benefits.
How Supplied:
How supplied storage condition: store at 20° to 25°c (68° to 7jof); excursions permitted to 15° to 30°c (59° to 86°f) (see usp controlled room temperature). protect from light. discard unused portion of the single dose vial. product repackaged by: henry schein, inc., bastian, va 24314 from original manufacturer/distributor's ndc and unit of sale to henry schein repackaged product ndc and unit of sale total strength/total volume (concentration) per unit ndc 0517-5601-25 boxes of 25 ndc 0404-9877-01 1 1ml single dose vial in a bag (vial bears ndc 0517-5601-25) 50 mg/ml ndc 0517-5602-25 boxes of 25 ndc 0404-9878-02 1 2 ml single dose vial in a bag (vial bears ndc 0517-5602-25) 50 mg/ml american regent, inc. shirley, ny 11967 in4201 rev. 10/16 mg #7842 image2.jpg
Package Label Principal Display Panel:
Sample package label label1.jpg