Levalbuterol Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

21 API Suppliers, 7 USDMF, 2 EU WC, 5 NDC API, 15 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

31 FDF Dossiers, 31 FDA Orange Book

DRUG PRODUCT COMPOSITIONS

SOLUTION;INHALATION - EQ 0.0103% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INHALATION - EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INHALATION - EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INHALATION - EQ 0.25% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Kirsch Pharma, 5 Actylis

EXCIPIENTS BY APPLICATIONS

5 Parenteral, 2 Controlled & Modified Release, 1 Thickeners and Stabilizers

DIGITAL CONTENT

7 News #PharmaBuzz

7 News #PharmaBuzz

GLOBAL SALES INFORMATION

11 US Medicaid Prescriptions, 5 Regulatory FDF Prices, 5 Annual Reports

MARKET PLACE

3 APIs

3 APIs

REF. STANDARDS & IMPURITIES

2 Others

2 Others

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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

The R-isomer of albuterol.

1 2D Structure

2D Structure

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 Formula	C₁₃H₂₂ClNO₃
Molecular Weight	275.77 g/mol
Hydrogen Bond Donor Count	5
Hydrogen Bond Acceptor Count	4
Rotatable Bond Count	5
Exact Mass	275.1288213 g/mol
Monoisotopic Mass	275.1288213 g/mol
Topological Polar Surface Area	72.7 Å²
Heavy Atom Count	18
Formal Charge	0
Complexity	227
Isotope Atom Count	0
Defined Atom Stereocenter Count	1
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Levalbuterol hydrochloride
Drug Label	Xopenex (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 Ingredient	Levalbuterol hydrochloride
Dosage Form	Solution
Route	Inhalation
Strength	eq 0.021% base; eq 0.25% base; eq 0.0103% base; eq 0.042% base
Market Status	Prescription
Company	Teva Parenteral; Teva Pharms Usa; Mylan Speclt; Cipla; Watson Labs

2 of 2
Drug Name	Levalbuterol hydrochloride
Drug Label	Xopenex (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 Ingredient	Levalbuterol hydrochloride
Dosage Form	Solution
Route	Inhalation
Strength	eq 0.021% base; eq 0.25% base; eq 0.0103% base; eq 0.042% base
Market Status	Prescription
Company	Teva 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]

Levalbuterol Hydrochloride

Levalbuterol Hydrochloride

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ACTIVE PHARMA INGREDIENTS

21 API Suppliers

7 USDMF

2 EU WC

5 NDC API

15 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

31 FDF Dossiers

31 FDA Orange Book

DRUG PRODUCT COMPOSITIONS

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

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

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

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

RELATED EXCIPIENT COMPANIES

2 Kirsch Pharma

5 Actylis

EXCIPIENTS BY APPLICATIONS

5 Parenteral

2 Controlled & Modified Release

1 Thickeners and Stabilizers

DIGITAL CONTENT

7 News #PharmaBuzz

GLOBAL SALES INFORMATION

11 US Medicaid Prescriptions

5 Regulatory FDF Prices

5 Annual Reports

MARKET PLACE

3 APIs

REF. STANDARDS & IMPURITIES

2 Others

Filters

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

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

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

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