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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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08-Feb-2021
26-Feb-2025
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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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Looking for 31884-77-2 / Meclizine Hydrochloride API manufacturers, exporters & distributors?

Meclizine Hydrochloride manufacturers, exporters & distributors 1

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

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Meclizine Hydrochloride manufacturer or Meclizine Hydrochloride supplier.

PharmaCompass also assists you with knowing the Meclizine Hydrochloride API Price utilized in the formulation of products. Meclizine Hydrochloride API Price is not always fixed or binding as the Meclizine Hydrochloride Price is obtained through a variety of data sources. The Meclizine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Meclizine Hydrochloride

Synonyms

Meclizine dihydrochloride monohydrate, 31884-77-2, Postafen, Agyrax, Bonamine, Hdp7w44cio

Cas Number

31884-77-2

Unique Ingredient Identifier (UNII)

HDP7W44CIO

About Meclizine Hydrochloride

A histamine H1 antagonist used in the treatment of motion sickness, vertigo, and nausea during pregnancy and radiation sickness.

Meclizine Manufacturers

A Meclizine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Meclizine, including repackagers and relabelers. The FDA regulates Meclizine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Meclizine 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Meclizine Suppliers

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

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

Meclizine USDMF

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

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

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

Meclizine CEP

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

A Meclizine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Meclizine 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 suppliers with CEP (COS) on PharmaCompass.

Meclizine WC

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

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

Meclizine 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 as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Meclizine 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Meclizine NDC to their finished compounded human drug products, they may choose to do so.

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

Meclizine GMP

Meclizine 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 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 GMP manufacturer or Meclizine GMP API supplier for your needs.

Meclizine CoA

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

Meclizine CoA mostly includes findings from lab analyses of a specific batch. For each Meclizine 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Meclizine EP), Meclizine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Meclizine 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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