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    Chemistry

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    Also known as: Meclizine hydrochloride, Meclizine dihydrochloride monohydrate, 31884-77-2, Postafen, Agyrax, Bonamine
    Molecular Formula
    C25H31Cl3N2O
    Molecular Weight
    481.9  g/mol
    InChI Key
    KDLHYOMCWBWLMM-UHFFFAOYSA-N
    FDA UNII
    HDP7W44CIO
    Meclizine Hydrochloride
    A histamine H1 antagonist used in the treatment of motion sickness, vertigo, and nausea during pregnancy and radiation sickness.
    1 2D Structure

    Meclizine Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    1-[(4-chlorophenyl)-phenylmethyl]-4-[(3-methylphenyl)methyl]piperazine;hydrate;dihydrochloride
    2.1.2 InChI
    InChI=1S/C25H27ClN2.2ClH.H2O/c1-20-6-5-7-21(18-20)19-27-14-16-28(17-15-27)25(22-8-3-2-4-9-22)23-10-12-24(26)13-11-23;;;/h2-13,18,25H,14-17,19H2,1H3;2*1H;1H2
    2.1.3 InChI Key
    KDLHYOMCWBWLMM-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC1=CC(=CC=C1)CN2CCN(CC2)C(C3=CC=CC=C3)C4=CC=C(C=C4)Cl.O.Cl.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    HDP7W44CIO
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Agyrax

    2. Antivert

    3. Bonamine

    4. Bonine

    5. Chiclida

    6. D Vert

    7. D-vert

    8. Dihydrochloride, Meclizine

    9. Dvert

    10. Histametizyn

    11. Hydrochloride, Meclizine

    12. Meclizine

    13. Meclizine Dihydrochloride

    14. Meclizine Hydrochloride

    15. Meclizine Monohydrochloride

    16. Meclozine

    17. Monohydrochloride, Meclizine

    18. Parachloramine

    19. Ru Vert M

    20. Ru-vert-m

    2.3.2 Depositor-Supplied Synonyms

    1. Meclizine Hydrochloride

    2. Meclizine Dihydrochloride Monohydrate

    3. 31884-77-2

    4. Postafen

    5. Agyrax

    6. Bonamine

    7. Hdp7w44cio

    8. Meclozine Hydrochloride Monohydrate

    9. Ucb-5062

    10. 1-[(4-chlorophenyl)-phenylmethyl]-4-[(3-methylphenyl)methyl]piperazine;hydrate;dihydrochloride

    11. Nsc-757094

    12. Piperazine, 1-((4-chlorophenyl)phenylmethyl)-4-((3-methylphenyl)methyl)-, Dihydrochloride, Monohydrate

    13. Mfcd00941489

    14. Meclizine Hcl Hydrate

    15. Nsc-28728

    16. Unii-hdp7w44cio

    17. Antivert (tn)

    18. Chembl3989555

    19. Chebi:31805

    20. Dtxsid30953792

    21. Meclizine Hydrochloride (jan/usp)

    22. Meclizine Hydrochloride [usp:jan]

    23. Bcp13363

    24. Meclizine Hydrochloride [jan]

    25. Meclizine Hydrochloride [vandf]

    26. Nsc 757094

    27. 1-(p-chloro-alpha-phenylbenzyl)-4-(m-methylbenzyl)piperazine Dihydrochloride Monohydrate

    28. Meclizine Hydrochloride [usp-rs]

    29. As-13740

    30. Meclizine Hydrochloride [orange Book]

    31. D01317

    32. Meclizine Hydrochloride [usp Monograph]

    33. A821043

    34. Meclizine Dihydrochloride Monohydrate [mi]

    35. (+/-)-meclizine Dihydrochloride Monohydrate

    36. Meclozine Hydrochloride Monohydrate [who-dd]

    37. Meclizine Dihydrochloride Monohydrate, (+/-)-

    38. Q27279880

    39. 1-((4-chlorophenyl)(phenyl)methyl)-4-(3-methylbenzyl)piperazine Dihydrochloride Hydrate

    40. 1-((4-chlorophenyl)(phenyl)methyl)-4-(3-methylbenzyl)piperazinedihydrochloridehydrate

    41. 1-(p-chloro-alpha-phenylbenzyl)-4-(m-methylbenzyl) Piperazine Dihydrochloride Monohydrate

    42. 1-(p-chloro-.alpha.-phenylbenzyl)-4-(m-methylbenzyl)piperazine Dihydrochloride Monohydrate

    43. 1-[(4-chlorophenyl)(phenyl)methyl]-4-[(3-methylphenyl)methyl]piperazine--hydrogen Chloride--water (1/2/1)

    44. 1-[(4-chlorophenyl)-phenyl-methyl]-4-(m-tolylmethyl)piperazine Hydrate Dihydrochloride;meclizine Dihydrochloride Monohydrate

    45. 1-[(4-chlorophenyl)phenylmethyl]-4-[(3-methylphenyl)methyl]piperazine Dihydrochloride Hydrate

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 481.9 g/mol
    Molecular Formula C25H31Cl3N2O
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count3
    Rotatable Bond Count5
    Exact Mass480.150197 g/mol
    Monoisotopic Mass480.150197 g/mol
    Topological Polar Surface Area7.5 Ų
    Heavy Atom Count31
    Formal Charge0
    Complexity448
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count4
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 1  
    Drug NameMECLIZINE HYDROCHLORIDE
    Active IngredientMECLIZINE HYDROCHLORIDE
    CompanyAMNEAL PHARMS (Application Number: A201451); EPIC PHARMA LLC (Application Number: A200294); JUBILANT CADISTA (Application Number: A040659); MYLAN PHARMS INC (Application Number: A202640); PAR PHARM (Application Number: A087127); PAR PHARM (Application Number: A087128); SANDOZ (Application Number: A084092); SANDOZ (Application Number: A084843)

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Anti-Allergic Agents

    Agents that are used to treat allergic reactions. Most of these drugs act by preventing the release of inflammatory mediators or inhibiting the actions of released mediators on their target cells. (From AMA Drug Evaluations Annual, 1994, p475) (See all compounds classified as Anti-Allergic Agents.)

    Antiemetics

    Drugs used to prevent NAUSEA or VOMITING. (See all compounds classified as Antiemetics.)

    Histamine H1 Antagonists

    Drugs that selectively bind to but do not activate histamine H1 receptors, thereby blocking the actions of endogenous histamine. Included here are the classical antihistaminics that antagonize or prevent the action of histamine mainly in immediate hypersensitivity. They act in the bronchi, capillaries, and some other smooth muscles, and are used to prevent or allay motion sickness, seasonal rhinitis, and allergic dermatitis and to induce somnolence. The effects of blocking central nervous system H1 receptors are not as well understood. (See all compounds classified as Histamine H1 Antagonists.)

    Cholinergic Antagonists

    Drugs that bind to but do not activate CHOLINERGIC RECEPTORS, thereby blocking the actions of ACETYLCHOLINE or cholinergic agonists. (See all compounds classified as Cholinergic Antagonists.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Emesis Suppression [PE]; Antiemetic [EPC]

    API Reference Price

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    07-Apr-2021
    22-Nov-2024
    KGS
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 12.5MG

    USFDA APPLICATION NUMBER - 10721

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    DOSAGE - TABLET;ORAL - 25MG

    USFDA APPLICATION NUMBER - 10721

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    DOSAGE - TABLET;ORAL - 50MG

    USFDA APPLICATION NUMBER - 10721

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    ABOUT THIS PAGE

    Meclizine Hydrochloride Manufacturers

    A Meclizine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Meclizine Hydrochloride, including repackagers and relabelers. The FDA regulates Meclizine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Meclizine Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Meclizine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Meclizine Hydrochloride Suppliers

    A Meclizine Hydrochloride supplier is an individual or a company that provides Meclizine Hydrochloride active pharmaceutical ingredient (API) or Meclizine Hydrochloride finished formulations upon request. The Meclizine Hydrochloride suppliers may include Meclizine Hydrochloride API manufacturers, exporters, distributors and traders.

    click here to find a list of Meclizine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Meclizine Hydrochloride USDMF

    A Meclizine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Meclizine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Meclizine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Meclizine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Meclizine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Meclizine Hydrochloride USDMF includes data on Meclizine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Meclizine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Meclizine Hydrochloride suppliers with USDMF on PharmaCompass.

    Meclizine Hydrochloride CEP

    A Meclizine Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Meclizine Hydrochloride Certificate of Suitability (COS). The purpose of a Meclizine Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Meclizine Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Meclizine Hydrochloride to their clients by showing that a Meclizine Hydrochloride CEP has been issued for it. The manufacturer submits a Meclizine Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Meclizine Hydrochloride CEP holder for the record. Additionally, the data presented in the Meclizine Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Meclizine Hydrochloride DMF.

    A Meclizine Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Meclizine Hydrochloride CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of Meclizine Hydrochloride suppliers with CEP (COS) on PharmaCompass.

    Meclizine Hydrochloride WC

    A Meclizine Hydrochloride written confirmation (Meclizine Hydrochloride WC) is an official document issued by a regulatory agency to a Meclizine Hydrochloride manufacturer, verifying that the manufacturing facility of a Meclizine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Meclizine Hydrochloride APIs or Meclizine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Meclizine Hydrochloride WC (written confirmation) as part of the regulatory process.

    click here to find a list of Meclizine Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.

    Meclizine Hydrochloride NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Meclizine Hydrochloride as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Meclizine Hydrochloride API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Meclizine Hydrochloride as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Meclizine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Meclizine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Meclizine Hydrochloride suppliers with NDC on PharmaCompass.

    Meclizine Hydrochloride GMP

    Meclizine Hydrochloride Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Meclizine Hydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Meclizine Hydrochloride GMP manufacturer or Meclizine Hydrochloride GMP API supplier for your needs.

    Meclizine Hydrochloride CoA

    A Meclizine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Meclizine Hydrochloride's compliance with Meclizine Hydrochloride specifications and serves as a tool for batch-level quality control.

    Meclizine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Meclizine Hydrochloride CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    Meclizine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Meclizine Hydrochloride EP), Meclizine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Meclizine Hydrochloride USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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