Hydroxyzine Hydrochloride
Lannett Company, Inc.
Human Prescription Drug
NDC 54838-502Hydroxyzine Hydrochloride is a human prescription drug labeled by 'Lannett Company, Inc.'. National Drug Code (NDC) number for Hydroxyzine Hydrochloride is 54838-502. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Hydroxyzine Hydrochloride drug includes Hydroxyzine Dihydrochloride - 10 mg/5mL . The currest status of Hydroxyzine Hydrochloride drug is Active.
Drug Information:
| Drug NDC: | 54838-502 |
| 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: | Lannett Company, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | 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 - 10 mg/5mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| 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: | 21 Aug, 2013 |
| 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: | ANDA201674 |
| 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: | Lannett Company, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 995241
|
| 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. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| 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 |
|---|
| 54838-502-80 | 473 mL in 1 BOTTLE, PLASTIC (54838-502-80) | 21 Aug, 2013 | 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 anhydrous citric acid sodium benzoate sucrose water sodium citrate slightly yellow peppermint flavor
Indications and Usage:
Indications and usage for symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. as a sedative when used in premedication and following general anesthesia, hydroxyzine may potentiate meperidine (demerol ® ) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. atropine and other belladonna alkaloids are not affected by the drug. hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. the effectiveness of hydroxyzine as an antianxiety agent for 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
Read more... for the individual patient.
Warnings:
Warnings nursing mothers: it is not known whether this drug is excreted in human milk. since many drugs are so excreted, hydroxyzine should not be given to nursing mothers.
Dosage and Administration:
Dosage and administration for symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: in adults, 50 to 100 mg four times daily.: children under 6 years, 50 mg daily in divided doses: children over 6 years: 50 to 100 mg daily in divided doses. for use in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus: in adults, 25 mg three times to four times daily.; children under 6 years, 50 mg daily in divided doses and children over 6 years, 50 to 100 mg daily in divided doses. as a sedative when used as a premedication and following general anesthesia: 50 to 100 mg in adults, and 0.6 mg/kg in children. when treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally. as with all medications, the dosage should be adjusted according to the patientâs
Read more...response to therapy.
Contraindications:
Contraindications oral hydroxyzine hydrochloride is contraindicated in patients with known hypersensitivity to hydroxyzine hydrochloride products, and in patients with known hypersensitivity to cetirizine hydrochloride or levocetirizine hydrochloride. hydroxyzine is contraindicated in patients with a prolonged qt interval. hydroxyzine, when administered to the pregnant mouse, rat and rabbit, induced fetal abnormalities in the rat and mouse 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. hydroxyzine is contraindicated for patients who have shown a previous hypersensitivity to any component of this medication.
Adverse Reactions:
Adverse reactions side effects reported with the administration of hydroxyzine hydrochloride are usually mild and transitory in nature. skin and appendages: oral hydroxyzine hydrochloride is associated with acute generalized exanthematous pustulosis (agep) and fixed drug eruptions in post marketing reports. anticholinergic: dry mouth. central nervous system: drowsiness is usually transitory and may disappear in a few days of continued therapy or upon reduction of the dose. involuntary motor activity including rare instances of tremor and convulsions have been reported, usually with doses considerably higher than those recommended. clinically significant respiratory depression has not been reported at recommended doses. cardiac system: qt prolongation, torsade de pointes. skin and appendages: pruritis, rash, uticaria
Overdosage:
Overdosage the most common manifestation of overdosage of hydroxyzine hydrochloride is hypersedation. other reported signs and symptoms were convulsions, stupor, nausea and vomiting. as in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken. if vomiting has not occurred spontaneously, it should be induced. immediate gastric lavage is also recommended. general supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated. hypotension, though unlikely, may be controlled with intravenous fluids and vasopressors (do not use epinephrine as hydroxyzine counteracts its pressor action). caffeine and sodium benzoate injection, usp, may be used to counteract central nervous system depressant effects. there is no specific antidote. it is doubtful that hemodialysis would be of any value in the treatment of overdosage with hydroxyzine. however, if other agents such as barbiturates have been ingested concomitantly, hemodialysis may be indicated. there is no practical method to quantitate hydroxyzine in body fluids or tissue after its ingestion or administration. hydroxyzine overdose may cause qt prolongation and torsade de pointes. ecg monitoring is recommended in cases of hydroxyzine overdose.
Description:
Description hydroxyzine hydrochloride is designated chemically as (±)-2-[2-[4-( p -chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. inert ingredients: citric acid, peppermint flavor, sodium benzoate, sucrose and water. citric acid and/or sodium citrate may be used to adjust the ph when necessary. molec-struc
Clinical Pharmacology:
Clinical pharmacology hydroxyzine hydrochloride is unrelated chemically to the phenothiazines, reserpine, meprobamate, or the benzodiazepines. hydroxyzine hydrochloride is not a cortical depressant, but its action may be due to suppression of activity in certain key regions of the subcortical area of the central nervous system. primary skeletal muscle relaxation has been demonstrated experimentally. bronchodilator activity, and antihistaminic and analgesic 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 has mild antisecretory activity. hydroxyzine is rapidly absorbed from the gastrointestinal tract and its clinical effects are usually noted within 15 to 30 minutes after oral administration.
How Supplied:
How supplied hydroxyzine hydrochloride syrup (hydroxyzine hydrochloride oral solution, usp) 10 mg per 5 ml (teaspoonful) is a slightly yellow peppermint flavored liquid, supplied in 473 ml (16 fl. oz.) amber plastic bottles. ndc 54838-502-80 store at controlled room temperature 15° to 30°c (59° to 86°f). [see usp controlled room temperature]. dispense in a tight, light-resistant container with child-resistant closure as defined in the usp. distributed by: lannett company, inc. philadelphia, pa 19136 10-1114 rev. 02/20
Package Label Principal Display Panel:
10-1064