Hydroxyzine
Hydroxyzine Hydrochloride
Major Pharmaceuticals
Human Prescription Drug
NDC 0904-0359Hydroxyzine also known as Hydroxyzine Hydrochloride is a human prescription drug labeled by 'Major Pharmaceuticals'. National Drug Code (NDC) number for Hydroxyzine is 0904-0359. This drug is available in dosage form of Tablet, Film Coated. The names of the active, medicinal ingredients in Hydroxyzine drug includes Hydroxyzine Hydrochloride - 50 mg/1 . The currest status of Hydroxyzine drug is Active.
Drug Information:
| Drug NDC: | 0904-0359 |
| 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 |
| 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: | Major Pharmaceuticals |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Film Coated |
| 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 HYDROCHLORIDE - 50 mg/1
|
| 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: | 20 Mar, 2007 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 Jan, 2026 |
| 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: | ANDA040788 |
| 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: | Major Pharmaceuticals
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 995218
995258
995281
|
| 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. |
| UPC: | 0309040359605
0309040357601
0309040358608
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 0904-0359-60 | 100 TABLET, FILM COATED in 1 BOTTLE (0904-0359-60) | 20 Mar, 2007 | 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 hydroxyzine hydrochloride hydroxyzine hydrochloride hydroxyzine carnauba wax silicon dioxide crospovidone (15 mpa.s at 5%) lactose monohydrate polyethylene glycol 3350 magnesium stearate microcrystalline cellulose polyvinyl alcohol, unspecified talc titanium dioxide biconvex k;10 hydroxyzine hydroxyzine hydrochloride hydroxyzine hydrochloride hydroxyzine silicon dioxide carnauba wax crospovidone (15 mpa.s at 5%) lactose monohydrate magnesium stearate microcrystalline cellulose polyvinyl alcohol, unspecified talc titanium dioxide polyethylene glycol 3350 biconvex k;11 hydroxyzine hydroxyzine hydrochloride hydroxyzine hydrochloride hydroxyzine carnauba wax silicon dioxide crospovidone (15 mpa.s at 5%) lactose monohydrate polyethylene glycol 3350 magnesium stearate microcrystalline cellulose polyvinyl alcohol, unspecified talc titanium dioxide biconvex k;12
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 as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine 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 for the indiv
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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: adults, 50 to100 mg q.i.d.; 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: adults, 25 mg t.i.d. or q.i.d.; children under 6 years, 50 mg daily in divided doses; 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 for adults and 0.6 mg/kg of body weight in children. when treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally. as with all potent medication, the dosage should be adjusted according to the patientâs response to thera
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Contraindications:
Contraindications 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 it.
Adverse Reactions:
Adverse reactions side effects reported with the administration of hydroxyzine hydrochloride are usually mild and transitory in nature. anticholinergic dry mouth. central nervous system drowsiness is usually transitory and may disappear in a few days of continued therapy or upon reduction of 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.
Geriatric Use:
Geriatric use section a determination has not been made whether controlled clinical studies of hydroxyzine included sufficient numbers of subjects aged 65 and over to define a difference in response from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. the extent of renal excretion of hydroxyzine has not been determined. because elderly patients are more likely to have decreased renal function, care should be taken in dose selections. sedating drugs may cause confusion and over sedation in the elderly; elderly patients generally should be started on low doses of hydroxyzine and observed closely.
Overdosage:
Overdosage the most common manifestation of hydroxyzine overdosage is hypersedation. 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 levarterenol or metaraminol. do not use epinephrine as hydroxyzine counteracts its pressor action. 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.
Description:
Description hydroxyzine hydrochloride has the chemical name of 2-[2-[4-( p -chloro-α-phenylbenzyl)- 1-piperazinyl]ethoxy] ethanol dihydrochloride. c21h27cin2o2â¢2hcl m.w. 447.83 hydroxyzine hydrochloride occurs as a white, odorless powder which is very soluble in water. each tablet for oral administration contains 10 mg, 25 mg or 50 mg hydroxyzine hydrochloride. inactive ingredients include carnauba wax, colloidal silicon dioxide, crospovidone, lactose monohydrate, macrogol/polyethylene glycol 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol - part. hydrolyzed, talc and titanium dioxide.
Clinical Pharmacology:
Clinical pharmacology hydroxyzine hydrochloride is unrelated chemically to the phenothiazines, reserpine, meprobamate or the benzodiazepines. hydroxyzine 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. 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 hydroxyzineâs clinical effects are usually noted within 15 to 30 minutes after oral administration.
Clinical Studies:
Clinical studies
How Supplied:
How supplied hydroxyzine hydrochloride tablets, usp are available as follows: hydroxyzine hydrochloride tablets, usp 10 mg are supplied as white, round, film coated, biconvex tablets debossed âk10â on one side and plain on the other sid in bottles of 100. ndc 0904-0357-60. hydroxyzine hydrochloride tablets, usp 25 mg are supplied as white, round, film coated, biconvex tablets debossed âk11â on one side and plain on the other side in bottles of 100, ndc 0904-0358-60. bottles of 1000, ndc 0904-0358-80. hydroxyzine hydrochloride tablets, usp 50 mg are supplied as white, round, film coated, biconvex tablets debossed âk12â on one side and plain on the other side in bottles of 100. ndc 0904-0359-60. dispense in a tight container as defined in the usp, with a child-resistant closure (as required). store at 20o to 25oc with excursions permitted between 15o to 30oc (59o to 86of) [see usp controlled room temperature].
Package Label Principal Display Panel:
Principal display panel ndc 0904-0357-60 hydroxyzine hcl tablets, usp 10mg rx only 100 tablets ndc 0904-0357-60 hydroxyzine hcl tablets, usp 10mg rx only 100 tablets
Package label principal display panel ndc 0904-0358-60 hydroxyzine hcl tablets, usp 25mg rx only 100 tablets ndc 0904-0358-60 hydroxyzine hcl tablets, usp 25mg rx only 100 tablets
Principal display panel ndc 0904-0359-60 hydroxyzine hcl tablets, usp 50mg rx only 100 tablets ndc 0904-0359-60 hydroxyzine hcl tablets, usp 50mg rx only 100 tablets