Meclizine Hydrochloride
Proficient Rx Lp
Human Prescription Drug
NDC 63187-258Meclizine Hydrochloride is a human prescription drug labeled by 'Proficient Rx Lp'. National Drug Code (NDC) number for Meclizine Hydrochloride is 63187-258. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Meclizine Hydrochloride drug includes Meclizine Hydrochloride - 25 mg/1 . The currest status of Meclizine Hydrochloride drug is Active.
Drug Information:
| Drug NDC: | 63187-258 |
| 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: | Meclizine 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: | Meclizine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Proficient Rx Lp |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| 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: | MECLIZINE HYDROCHLORIDE - 25 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: | 30 Apr, 2012 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 17 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: | ANDA200294 |
| 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: | Proficient Rx LP
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 995666
|
| 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: | HDP7W44CIO
|
| 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: | Antiemetic [EPC]
Emesis Suppression [PE]
|
| 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 |
|---|
| 63187-258-10 | 10 TABLET in 1 BOTTLE (63187-258-10) | 01 Jan, 2019 | N/A | No |
| 63187-258-20 | 20 TABLET in 1 BOTTLE (63187-258-20) | 01 Jan, 2019 | N/A | No |
| 63187-258-30 | 30 TABLET in 1 BOTTLE (63187-258-30) | 01 Jan, 2019 | N/A | No |
| 63187-258-60 | 60 TABLET in 1 BOTTLE (63187-258-60) | 01 Jan, 2019 | N/A | No |
| 63187-258-90 | 90 TABLET in 1 BOTTLE (63187-258-90) | 01 Jan, 2019 | 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:
Meclizine hydrochloride meclizine hydrochloride meclizine hydrochloride meclizine microcrystalline cellulose lactose monohydrate croscarmellose sodium magnesium stearate e14
Boxed Warning:
Based on a review of this drug by the national academy of sciences - national research council and/or other information, fda has classified the indications as follows: effective: management of nausea and vomiting, and dizziness associated with motion sickness. final classification of the less than effective indications requires further investigation.
Warnings:
Warnings since drowsiness may, on occasion, occur with use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery. patients should avoid alcoholic beverages while taking this drug. due to its potential anticholinergic action, this drug should be used with caution in patients with asthma, glaucoma, or enlargement of the prostate gland. usage in children clinical studies establishing safety and effectiveness in children have not been done; therefore, usage is not recommended in children under 12 years of age. usage in pregnancy pregnancy category b reproduction studies in rats have shown cleft palates at 25-50 times the human dose. epidemiological studies in pregnant women, however, do not indicate that meclizine increases the risk of abnormalities when administered during pregnancy. despite the animal findings, it would appear that the possibility of fetal harm is remote. nevertheless, meclizine, or any other medi
Read more...cation, should be used during pregnancy only if clearly necessary.
Usage in children clinical studies establishing safety and effectiveness in children have not been done; therefore, usage is not recommended in children under 12 years of age.
Usage in pregnancy pregnancy category b reproduction studies in rats have shown cleft palates at 25-50 times the human dose. epidemiological studies in pregnant women, however, do not indicate that meclizine increases the risk of abnormalities when administered during pregnancy. despite the animal findings, it would appear that the possibility of fetal harm is remote. nevertheless, meclizine, or any other medication, should be used during pregnancy only if clearly necessary.
Pregnancy category b reproduction studies in rats have shown cleft palates at 25-50 times the human dose. epidemiological studies in pregnant women, however, do not indicate that meclizine increases the risk of abnormalities when administered during pregnancy. despite the animal findings, it would appear that the possibility of fetal harm is remote. nevertheless, meclizine, or any other medication, should be used during pregnancy only if clearly necessary.
Dosage and Administration:
Dosage and administration motion sickness the initial dose of 25 to 50 mg of meclizine hydrochloride should be taken one hour prior to embarkation for protection against motion sickness. thereafter, the dose may be repeated every 24 hours for the duration of the journey.
Motion sickness the initial dose of 25 to 50 mg of meclizine hydrochloride should be taken one hour prior to embarkation for protection against motion sickness. thereafter, the dose may be repeated every 24 hours for the duration of the journey.
Contraindications:
Contraindications meclizine hydrochloride is contraindicated in individuals who have shown a previous hypersensitivity to it.
Adverse Reactions:
Adverse reactions anaphylactoid reaction, drowsiness, dry mouth, headache, fatigue, vomiting and, on rare occasions, blurred vision have been reported.
Description:
Description chemically, meclizine hydrochloride is 1-( p -chloro-α-phenylbenzyl)-4-( m -methylbenzyl) piperazine dihydrochloride monohydrate. c 25 h 27 cin 2 ·2hcl·h 2 0 m.w. 481.89 meclizine hydrochloride tablets, usp are available in two different strengths, 12.5 mg and 25 mg. inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium and magnesium stearate. the 12.5 mg tablet also contains fd&c blue #1 aluminum lake. chemical structure
Clinical Pharmacology:
Clinical pharmacology meclizine hydrochloride is an antihistamine that shows marked protective activity against nebulized histamine and lethal doses of intravenously injected histamine in guinea pigs. it has a marked effect in blocking the vasodepressor response to histamine, but only a slight blocking action against acetylcholine. its activity is relatively weak in inhibiting the spasmogenic action of histamine on isolated guinea pig ileum. pharmacokinetics the available pharmacokinetic information for meclizine following oral administration has been summarized from published literature. absorption meclizine is absorbed after oral administration with maximum plasma concentrations reaching at a median tmax value of 3 hours post-dose (range: 1.5 to 6 hours) for the tablet dosage form. distribution drug distribution characteristics for meclizine in humans are unknown. metabolism the metabolic fate of meclizine in humans is unknown. in an in vitro metabolic study using human hepatic micro
Read more...some and recombinant cyp enzyme, cyp 2d6 was found to be the dominant enzyme for metabolism of meclizine. the genetic polymorphism of cyp2d6 that results in extensive-, poor-, intermediate- and ultrarapid metabolizer phenotypes could contribute to large inter-individual variability in meclizine exposure. elimination meclizine has a plasma elimination half-life of about 5-6 hours in humans.
Pharmacokinetics:
Pharmacokinetics the available pharmacokinetic information for meclizine following oral administration has been summarized from published literature. absorption meclizine is absorbed after oral administration with maximum plasma concentrations reaching at a median tmax value of 3 hours post-dose (range: 1.5 to 6 hours) for the tablet dosage form. distribution drug distribution characteristics for meclizine in humans are unknown. metabolism the metabolic fate of meclizine in humans is unknown. in an in vitro metabolic study using human hepatic microsome and recombinant cyp enzyme, cyp 2d6 was found to be the dominant enzyme for metabolism of meclizine. the genetic polymorphism of cyp2d6 that results in extensive-, poor-, intermediate- and ultrarapid metabolizer phenotypes could contribute to large inter-individual variability in meclizine exposure. elimination meclizine has a plasma elimination half-life of about 5-6 hours in humans.
How Supplied:
How supplied meclizine hydrochloride tablets usp are available as: 25 mg, white, modified oval-shaped tablets, de-bossed â Ð14 â on one side and plain on the other side. they are supplied as follows: ndc 63187-258-10 in bottles of 10 ndc 63187-258-20 in bottles of 20 ndc 63187-258-30 in bottles of 30 ndc 63187-258-60 in bottles of 60 ndc 63187-258-90 in bottles of 90 store at 20º to 25ºc (68 to 77ºf) [see usp controlled room temperature]. dispense contents in a tight, light-resistant container as defined in the usp, with a child-resistant closure, as required. manufactured by: epic pharma, llc laurelton, ny 11413 made in usa revised april 2014 mf012rev04/14 oe1035 repackaged by: proficient rx lp thousand oaks, ca 91320
Package Label Principal Display Panel:
Principal display panel 63187-258-10