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Chemistry

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Also known as: 50293-90-8, Levalbuterol hcl, Xopenex, (r)-albuterol hydrochloride, Levosalbutamol hydrochloride, R-albuterol hydrochloride
Molecular Formula
C13H22ClNO3
Molecular Weight
275.77  g/mol
InChI Key
OWNWYCOLFIFTLK-YDALLXLXSA-N
FDA UNII
WDQ1526QJM

Levalbuterol Hydrochloride
The R-isomer of albuterol.
1 2D Structure

Levalbuterol Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;hydrochloride
2.1.2 InChI
InChI=1S/C13H21NO3.ClH/c1-13(2,3)14-7-12(17)9-4-5-11(16)10(6-9)8-15;/h4-6,12,14-17H,7-8H2,1-3H3;1H/t12-;/m0./s1
2.1.3 InChI Key
OWNWYCOLFIFTLK-YDALLXLXSA-N
2.1.4 Canonical SMILES
CC(C)(C)NCC(C1=CC(=C(C=C1)O)CO)O.Cl
2.1.5 Isomeric SMILES
CC(C)(C)NC[C@@H](C1=CC(=C(C=C1)O)CO)O.Cl
2.2 Other Identifiers
2.2.1 UNII
WDQ1526QJM
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Hydrochloride, Levalbuterol

2. Hydrochloride, Levosalbutamol

3. Levalbuterol

4. Levosalbutamol Hydrochloride

5. Xopenex

2.3.2 Depositor-Supplied Synonyms

1. 50293-90-8

2. Levalbuterol Hcl

3. Xopenex

4. (r)-albuterol Hydrochloride

5. Levosalbutamol Hydrochloride

6. R-albuterol Hydrochloride

7. (r)-salbutamol Hydrochloride

8. Levalbuterol Hydrochloride [usan:usp]

9. Nsc-759255

10. Albuterol Hydrochloride, R-

11. Wdq1526qjm

12. (r)-4-(2-(tert-butylamino)-1-hydroxyethyl)-2-(hydroxymethyl)phenol Hydrochloride

13. (r)-albuterol

14. 50293-90-8(hcl)

15. 148563-16-0

16. Alfa1-[[1,1-dimethylethylamino]methyl]-4-hydroxy-1-(s),3-benzene Dimethanol Hydrochlorid

17. (-)-salbutamol Hydrochloride

18. Zopenex

19. Levalbuterol Hydrochloride [usan]

20. Unii-wdq1526qjm

21. (r)-4-[2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol Hydrochloride

22. Xopenex (tn)

23. Zopenex [common Misspelling Of Xopenex]

24. Salbutamol (hydrochloride)

25. Schembl40682

26. Chembl1201061

27. Albuterol (r)-form Hydrochloride

28. Levalbuterol Hydrochloride (usp)

29. Dtxsid20198296

30. Pharmakon1600-01505811

31. Bcp04477

32. Ccg-39986

33. Mfcd08067728

34. Nsc759255

35. Akos015961919

36. (r)-salbutamol ((r)-albuterol Hcl)

37. Bs-1006

38. Nsc 759255

39. (r)-alpha(sup 1)-((tert-butylamino)methyl)-4-hydroxy-m-xylene-alpha,alpha'-diol Hydrochloride

40. 4-[(1r)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol Hydrochloride

41. 1,3-benzenedimethanol, Alpha1-(((1,1-dimethylethyl)amino)methyl)-4-hydroxy-, Hydrochloride, (alpha1r)-

42. 2-(hydroxymethyl)-4-{(1r)-1-hydroxy-2-[(2-methyl-2-propanyl)amino ]ethyl}phenol Hydrochloride (1:1)

43. Ac-23919

44. Levalbuterol Hydrochloride [usp-rs]

45. Levalbuterol Hydrochloride, >=98% (hplc)

46. Levosalbutamol Hydrochloride [mart.]

47. Levosalbutamol Hydrochloride [who-dd]

48. Albuterol (r)-form Hydrochloride [mi]

49. D02281

50. Levalbuterol Hydrochloride [orange Book]

51. 293l908

52. A928075

53. Levalbuterol Hydrochloride [usp Monograph]

54. Q27292577

55. 4-[(1r)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;hydrochloride

56. Alfa1-[[1,1-dimethylethylamino]methyl]-4-hydroxy-1-(s),3-benzenedimethanolhydrochlorid

57. Levalbuterol Hydrochloride, United States Pharmacopeia (usp) Reference Standard

58. (r)-.alpha.(sup 1)-((tert-butylamino)methyl)-4-hydroxy-m-xylene-.alpha.,.alpha.'-diol Hydrochloride

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 275.77 g/mol
Molecular Formula C13H22ClNO3
Hydrogen Bond Donor Count5
Hydrogen Bond Acceptor Count4
Rotatable Bond Count5
Exact Mass275.1288213 g/mol
Monoisotopic Mass275.1288213 g/mol
Topological Polar Surface Area72.7 Ų
Heavy Atom Count18
Formal Charge0
Complexity227
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameLevalbuterol hydrochloride
Drug LabelXopenex (levalbuterol HCl) Inhalation Solution is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selectiv...
Active IngredientLevalbuterol hydrochloride
Dosage FormSolution
RouteInhalation
Strengtheq 0.021% base; eq 0.25% base; eq 0.0103% base; eq 0.042% base
Market StatusPrescription
CompanyTeva Parenteral; Teva Pharms Usa; Mylan Speclt; Cipla; Watson Labs

2 of 2  
Drug NameLevalbuterol hydrochloride
Drug LabelXopenex (levalbuterol HCl) Inhalation Solution is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selectiv...
Active IngredientLevalbuterol hydrochloride
Dosage FormSolution
RouteInhalation
Strengtheq 0.021% base; eq 0.25% base; eq 0.0103% base; eq 0.042% base
Market StatusPrescription
CompanyTeva Parenteral; Teva Pharms Usa; Mylan Speclt; Cipla; Watson Labs

5 Pharmacology and Biochemistry
5.1 FDA Pharmacological Classification
5.1.1 Pharmacological Classes
beta2-Adrenergic Agonist [EPC]; Adrenergic beta2-Agonists [MoA]

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16-Feb-2021
22-May-2024
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - SOLUTION;INHALATION - EQ 0.0103% BAS...DOSAGE - SOLUTION;INHALATION - EQ 0.0103% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20837

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DOSAGE - SOLUTION;INHALATION - EQ 0.021% BASE...DOSAGE - SOLUTION;INHALATION - EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20837

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DOSAGE - SOLUTION;INHALATION - EQ 0.042% BASE...DOSAGE - SOLUTION;INHALATION - EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20837

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DOSAGE - SOLUTION;INHALATION - EQ 0.25% BASE ...DOSAGE - SOLUTION;INHALATION - EQ 0.25% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20837

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ABOUT THIS PAGE

Looking for 50293-90-8 / Levalbuterol Hydrochloride API manufacturers, exporters & distributors?

Levalbuterol Hydrochloride manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Levalbuterol 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 Levalbuterol Hydrochloride manufacturer or Levalbuterol Hydrochloride supplier for your needs.

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

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

API | Excipient name

Levalbuterol Hydrochloride

Synonyms

50293-90-8, Levalbuterol hcl, Xopenex, (r)-albuterol hydrochloride, Levosalbutamol hydrochloride, R-albuterol hydrochloride

Cas Number

50293-90-8

Unique Ingredient Identifier (UNII)

WDQ1526QJM

About Levalbuterol Hydrochloride

The R-isomer of albuterol.

Levalbuterol Hydrochloride Manufacturers

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

Levalbuterol Hydrochloride Suppliers

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

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

Levalbuterol Hydrochloride USDMF

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

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

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

Levalbuterol Hydrochloride WC

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

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

Levalbuterol 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 Levalbuterol Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Levalbuterol Hydrochloride GMP

Levalbuterol 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 Levalbuterol 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 Levalbuterol Hydrochloride GMP manufacturer or Levalbuterol Hydrochloride GMP API supplier for your needs.

Levalbuterol Hydrochloride CoA

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

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

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