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Also known as: 130018-87-0, Xyzal, Xusal, (r)-cetirizine dihydrochloride, Levocetirizine hcl, Levocetirizine dihydrochloride [usan]
Molecular Formula
C21H27Cl3N2O3
Molecular Weight
461.8  g/mol
InChI Key
PGLIUCLTXOYQMV-GHVWMZMZSA-N
FDA UNII
SOD6A38AGA

Levocetirizine Dihydrochloride
Levocetirizine Dihydrochloride is the dihydrochloride salt form of the active levorotatory enantiomer of cetirizine, levocetirizine; a third generation, non-sedating, selective histamine H1 receptor antagonist, with antihistamine, anti-inflammatory and potential anti-angiogenic activities. Levocetirizine competes with endogenous histamine for binding at peripheral H1-receptor sites on the effector cell surface. This prevents the negative symptoms associated with histamine release and an allergic reaction. In addition, as histamine plays an important role in angiogenesis during an allergic inflammatory reaction, blocking the action of histamine may modulate the expression of proangiogenic factors and thus may prevent angiogenesis. As a third-generation histamine H1 receptor antagonist, levocetirizine has fewer side effects than most second-generation antihistamines.
1 2D Structure

Levocetirizine Dihydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-[2-[4-[(R)-(4-chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]acetic acid;dihydrochloride
2.1.2 InChI
InChI=1S/C21H25ClN2O3.2ClH/c22-19-8-6-18(7-9-19)21(17-4-2-1-3-5-17)24-12-10-23(11-13-24)14-15-27-16-20(25)26;;/h1-9,21H,10-16H2,(H,25,26);2*1H/t21-;;/m1../s1
2.1.3 InChI Key
PGLIUCLTXOYQMV-GHVWMZMZSA-N
2.1.4 Canonical SMILES
C1CN(CCN1CCOCC(=O)O)C(C2=CC=CC=C2)C3=CC=C(C=C3)Cl.Cl.Cl
2.1.5 Isomeric SMILES
C1CN(CCN1CCOCC(=O)O)[C@H](C2=CC=CC=C2)C3=CC=C(C=C3)Cl.Cl.Cl
2.2 Other Identifiers
2.2.1 UNII
SOD6A38AGA
2.3 Synonyms
2.3.1 MeSH Synonyms

1. (2-(4-((r)-(4-chlorophenyl)phenylmethyl)piperazin-1-yl)ethoxy)acetic Acid Dihydrochloride

2. (2-(4-((r)-p-chloro-alpha-phenylbenzyl)-1-piperazinyl)ethoxy)acetic Acid

3. Acetic Acid, (2-(4-((r)-(4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)-

4. Acetic Acid, (2-(4-((r)-(4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)-, Dihydrochloride

5. Cetirizine (r)-form Dihydrochloride

6. Levocetirizine

7. Levocetirizine Hydrochloride

8. Levocetrizine

9. Ucb-28556

10. Xusal

11. Xyzal

2.3.2 Depositor-Supplied Synonyms

1. 130018-87-0

2. Xyzal

3. Xusal

4. (r)-cetirizine Dihydrochloride

5. Levocetirizine Hcl

6. Levocetirizine Dihydrochloride [usan]

7. Cetirizine (r)-form Dihydrochloride

8. Ucb-28556

9. Sod6a38aga

10. Ucb 28556

11. (2-(4-((r)-(4-chlorophenyl)phenylmethyl)piperazin-1-yl)ethoxy)acetic Acid Dihydrochloride

12. (r)-2-(2-(4-((4-chlorophenyl)(phenyl)methyl)piperazin-1-yl)ethoxy)acetic Acid Dihydrochloride

13. Acetic Acid, (2-(4-((r)-(4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)-, Dihydrochloride

14. Nsc-758898

15. Levocetirizine Hydrochloride (jan)

16. (-)-cetirizine Dihydrochloride

17. 2-[2-[4-[(r)-(4-chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]acetic Acid;dihydrochloride

18. 2-[2-[4-[(r)-(4-chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]acetic Acid Dihydrochloride

19. Levocetirizine (dihydrochloride)

20. Levocetirizine Hydrochloride [jan]

21. Levocetirizine 2hcl

22. Unii-sod6a38aga

23. Levocetirizine Dihcl

24. Mfcd07366507

25. Xyzal Allergy 24hr

26. Xyzal (tn)

27. Levocetirizinedihydrochloride

28. Schembl144375

29. Chembl1201190

30. Levocetirizine Hydrochloride,(s)

31. Dtxsid30926567

32. Bcp21544

33. Ac-549

34. Levocetirizine Dihydrochloride (usp)

35. S4849

36. Akos015994681

37. Ccg-269359

38. Cs-w011557

39. Hy-w010841

40. Ks-1177

41. Nsc 758898

42. [2-[4-[(r)-(4-chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]-acetic Acid 2hcl

43. 2-[2-[4-[(r)-(4-chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]acetic Acid Dihydrochloride

44. Levocetirizine Hydrochloride [mart.]

45. L0264

46. Levocetirizine Dihydrochloride [vandf]

47. Levocetirizine(r)-cetirizine (hydrochloride)

48. D08118

49. Levocetirizine Dihydrochloride [usp-rs]

50. Levocetirizine Dihydrochloride [who-dd]

51. Levocetirizine Dihydrochloride, >=98% (hplc)

52. Cetirizine (r)-form Dihydrochloride [mi]

53. 018l870

54. Levocetirizine Dihydrochloride [orange Book]

55. Levocetirizine Dihydrochloride [usp Monograph]

56. Q27289313

57. [2-[4-[(r)-(4-chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]-acetic Acid Dihydrochloride

2.4 Create Date
2006-10-25
3 Chemical and Physical Properties
Molecular Weight 461.8 g/mol
Molecular Formula C21H27Cl3N2O3
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count5
Rotatable Bond Count8
Exact Mass460.108726 g/mol
Monoisotopic Mass460.108726 g/mol
Topological Polar Surface Area53 Ų
Heavy Atom Count29
Formal Charge0
Complexity443
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameLevocetirizine dihydrochloride
Drug LabelLevocetirizine dihydrochloride, the active component of levocetirizine dihydrochloride tablets, is an orally active H1-receptor antagonist. The chemical name is R-(+)-2-[2-[4-[(4-chlorophenyl) phenyl methyl] piperazin-1-yl] ethoxy] acetic acid dihydr...
Active IngredientLevocetirizine dihydrochloride
Dosage FormTablet; Solution
RouteOral
Strength2.5mg/5ml; 5mg
Market StatusPrescription
CompanySynthon Pharms; Apotex; Hetero Labs Ltd Iii; Sciegen Pharms; Taro Pharm Inds; Sun Pharma Global; Glenmark Generics; Teva Pharms; Micro Labs Ltd India; Dr Reddys Labs; L Perrigo

2 of 4  
Drug NameXyzal
PubMed HealthLevocetirizine (By mouth)
Drug ClassesRespiratory Agent
Drug LabelLevocetirizine dihydrochloride, the active component of XYZAL tablets and oral solution, is an orally active H1receptor antagonist. The chemical name is (R)-[2-[4-[(4-chlorophenyl) phenylmethyl]-1-piperazinyl] ethoxy] acetic acid dihydrochloride....
Active IngredientLevocetirizine dihydrochloride
Dosage FormTablet; Solution
RouteOral
Strength2.5mg/5ml; 5mg
Market StatusPrescription
CompanyUcb

3 of 4  
Drug NameLevocetirizine dihydrochloride
Drug LabelLevocetirizine dihydrochloride, the active component of levocetirizine dihydrochloride tablets, is an orally active H1-receptor antagonist. The chemical name is R-(+)-2-[2-[4-[(4-chlorophenyl) phenyl methyl] piperazin-1-yl] ethoxy] acetic acid dihydr...
Active IngredientLevocetirizine dihydrochloride
Dosage FormTablet; Solution
RouteOral
Strength2.5mg/5ml; 5mg
Market StatusPrescription
CompanySynthon Pharms; Apotex; Hetero Labs Ltd Iii; Sciegen Pharms; Taro Pharm Inds; Sun Pharma Global; Glenmark Generics; Teva Pharms; Micro Labs Ltd India; Dr Reddys Labs; L Perrigo

4 of 4  
Drug NameXyzal
PubMed HealthLevocetirizine (By mouth)
Drug ClassesRespiratory Agent
Drug LabelLevocetirizine dihydrochloride, the active component of XYZAL tablets and oral solution, is an orally active H1receptor antagonist. The chemical name is (R)-[2-[4-[(4-chlorophenyl) phenylmethyl]-1-piperazinyl] ethoxy] acetic acid dihydrochloride....
Active IngredientLevocetirizine dihydrochloride
Dosage FormTablet; Solution
RouteOral
Strength2.5mg/5ml; 5mg
Market StatusPrescription
CompanyUcb

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Histamine H1 Antagonists, Non-Sedating

A class of non-sedating drugs that bind to but do not activate histamine receptors (DRUG INVERSE AGONISM), thereby blocking the actions of histamine or histamine agonists. These antihistamines represent a heterogenous group of compounds with differing chemical structures, adverse effects, distribution, and metabolism. Compared to the early (first generation) antihistamines, these non-sedating antihistamines have greater receptor specificity, lower penetration of BLOOD-BRAIN BARRIER, and are less likely to cause drowsiness or psychomotor impairment. (See all compounds classified as Histamine H1 Antagonists, Non-Sedating.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Histamine-1 Receptor Antagonist [EPC]; Histamine H1 Receptor Antagonists [MoA]

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12-Jan-2022
30-Jun-2025
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DOSAGE - SOLUTION;ORAL - 2.5MG/5ML

USFDA APPLICATION NUMBER - 209090

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DOSAGE - TABLET;ORAL - 5MG **Federal Register...DOSAGE - TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22064

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DOSAGE - SOLUTION;ORAL - 2.5MG/5ML **Federal ...DOSAGE - SOLUTION;ORAL - 2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22157

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ABOUT THIS PAGE

Looking for 130018-87-0 / Levocetirizine Dihydrochloride API manufacturers, exporters & distributors?

Levocetirizine Dihydrochloride manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Levocetirizine Dihydrochloride 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 Levocetirizine Dihydrochloride manufacturer or Levocetirizine Dihydrochloride supplier for your needs.

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

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

API | Excipient name

Levocetirizine Dihydrochloride

Synonyms

130018-87-0, Xyzal, Xusal, (r)-cetirizine dihydrochloride, Levocetirizine hcl, Levocetirizine dihydrochloride [usan]

Cas Number

130018-87-0

Unique Ingredient Identifier (UNII)

SOD6A38AGA

About Levocetirizine Dihydrochloride

Levocetirizine Dihydrochloride is the dihydrochloride salt form of the active levorotatory enantiomer of cetirizine, levocetirizine; a third generation, non-sedating, selective histamine H1 receptor antagonist, with antihistamine, anti-inflammatory and potential anti-angiogenic activities. Levocetirizine competes with endogenous histamine for binding at peripheral H1-receptor sites on the effector cell surface. This prevents the negative symptoms associated with histamine release and an allergic reaction. In addition, as histamine plays an important role in angiogenesis during an allergic inflammatory reaction, blocking the action of histamine may modulate the expression of proangiogenic factors and thus may prevent angiogenesis. As a third-generation histamine H1 receptor antagonist, levocetirizine has fewer side effects than most second-generation antihistamines.

Xyzal Manufacturers

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

Xyzal Suppliers

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

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

Xyzal USDMF

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

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

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

Xyzal JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Xyzal Drug Master File in Japan (Xyzal JDMF) empowers Xyzal API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Xyzal JDMF during the approval evaluation for pharmaceutical products. At the time of Xyzal JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Xyzal suppliers with JDMF on PharmaCompass.

Xyzal KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Xyzal Drug Master File in Korea (Xyzal KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Xyzal. The MFDS reviews the Xyzal KDMF as part of the drug registration process and uses the information provided in the Xyzal KDMF to evaluate the safety and efficacy of the drug.

After submitting a Xyzal KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Xyzal API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Xyzal suppliers with KDMF on PharmaCompass.

Xyzal CEP

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

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

Xyzal WC

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

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

Xyzal 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 Xyzal as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Xyzal GMP

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

Xyzal CoA

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

Xyzal CoA mostly includes findings from lab analyses of a specific batch. For each Xyzal 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.

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