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Technical details about Albuterol, learn more about the structure, uses, toxicity, action, side effects and more

Albuterol

Synopsis, Chemistry

APIs // Active Pharmaceutical Ingredients

54 Suppliers, 27 USDMF, 11 CEP/COS, 1 JDMF, 7 EU WC, 2 KDMF, 22 NDC API, 35 Listed Suppliers

DEVELOPMENTS

15 Drug(s) in Development

15 Drug(s) in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Exports, FDF Imports

INTERMEDIATES

2 Suppliers

2 Suppliers

DOSSIERs // Finished Dosage Forms

356 Dossiers, 131 FDA Orange Book, 89 Europe, 21 Canada, 18 Australia, 41 South Africa, 56 Listed Dossiers

DRUG PRODUCT COMPOSITION

AEROSOL, METERED;INHALATION - EQ 0.09MG BASE/INH, SOLUTION;INHALATION - EQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, AEROSOL, METERED;INHALATION - EQ 0.09MG BASE/INH, AEROSOL, METERED;INHALATION - EQ 0.09MG BASE/INH

RELATED EXCIPIENT COMPANIES

Suppliers, 35 Kerry, 26 Roquette, 17 BASF, 13 Microlex e.U, 11 Actylis, 11 Corel Pharma Chem, 10 Sigachi Industries, 9 Gangwal Healthcare, 8 Seppic, 6 Gangwal Chemicals, 6 Lonza Capsugel, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 6 DFE Pharma, 6 SPI Pharma, 5 Ideal Cures Pvt Ltd, 5 Nanjing Well Pharmaceutical, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 4 Kima Chemical, 3 The Dow Chemical Company, 3 Prachin Chemical, 3 Vasa Pharmachem, 3 Rochem International Inc, 3 Ingredion Pharma Solutions, 3 DKSH, 3 Finar, 2 Seqens, 2 Pharmatrans-Sanaq, 2 Nomisma Healthcare, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Qualicaps, 1 ACG Worldwide, 1 Pharm-RX Chemical, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

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GLOBAL SALES INFORMATION

57 US Medicaid Prescriptions, 72 Finished Drug Prices

MARKET PLACE

25 APIs, 14 DOSSIERS // FDF, 1 EXCIPIENTS

PATENTS

45 US Patents, 5 Health Canada Patents

ANALYTICAL SOLUTION(s)

5 EDQM Standards, 5 USP Standards, 23 Other Ref. Standards

DIGITAL CONTENT

4 Data Compilation & Company Tracker #PharmaFlow, 83 News

Also known as: Salbutamol sulfate, 51022-70-9, Salbutamol hemisulfate, Proventil, Venetlin, Loftan

Molecular Formula

C₂₆H₄₄N₂O₁₀S

Molecular Weight

576.7 g/mol

InChI Key

BNPSSFBOAGDEEL-UHFFFAOYSA-N

FDA UNII

021SEF3731

A short-acting beta-2 adrenergic agonist that is primarily used as a bronchodilator agent to treat ASTHMA. Albuterol is prepared as a racemic mixture of R(-) and S(+) stereoisomers. The stereospecific preparation of R(-) isomer of albuterol is referred to as levalbuterol.

1 2D Structure

2D Structure

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

4-[2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric acid

2.1.2 InChI

InChI=1S/2C13H21NO3.H2O4S/c2*1-13(2,3)14-7-12(17)9-4-5-11(16)10(6-9)8-15;1-5(2,3)4/h2*4-6,12,14-17H,7-8H2,1-3H3;(H2,1,2,3,4)

2.1.3 InChI Key

BNPSSFBOAGDEEL-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CC(C)(C)NCC(C1=CC(=C(C=C1)O)CO)O.CC(C)(C)NCC(C1=CC(=C(C=C1)O)CO)O.OS(=O)(=O)O

2.2 Other Identifiers

2.2.1 UNII

021SEF3731

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 2-t-butylamino-1-(4-hydroxy-3-hydroxy-3-hydroxymethyl)phenylethanol

2. Albuterol

3. Proventil

4. Salbutamol

5. Sultanol

6. Ventolin

2.3.2 Depositor-Supplied Synonyms

1. Salbutamol Sulfate

2. 51022-70-9

3. Salbutamol Hemisulfate

4. Proventil

5. Venetlin

6. Loftan

7. Albuterol Hemisulfate

8. Bronchospray

9. Ventolin

10. Accuneb

11. Proventil-hfa

12. Salbutamol Sulphate

13. Sch 13949w Sulfate

14. Proair

15. Ventolin Rotacaps

16. Proair Respiclick

17. Vospire Er

18. Sultanol

19. Ventilastin

20. Ecovent

21. Salbumol

22. Vospire

23. Albuterol Sulfate(2:1)

24. Albuterol Sulphate

25. 36519-31-0

26. Buventol

27. Salamol

28. Salbutamol (as Sulfate)

29. Sch 13949w Sulphate

30. Sch-13949w Sulphate

31. Sulbutamol (as Sulphate)

32. Sch-13949w Sulfate

33. 4-[2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric Acid

34. R03ac02

35. R03cc02

36. Aerolin

37. Airomir

38. 021sef3731

39. Nsc-289928

40. Aerotec

41. Aloprol

42. Amocasin

43. Broncodil

44. Dipulmin

45. Fartolin

46. Inspiryl

47. Emican

48. Proventil (tn)

49. Epaq

50. Broncho Inhalat

51. Huma-salmol

52. Ventolin Hfa

53. Dl-salbutamol Sulfate

54. (+-)-salbutamol Sulfate

55. 2-(tert-butylamino)-1-(4-hydroxy-3-hydroxymethylphenyl)ethanol Hemisulfate

56. 5-[2-(tert-butylamino)-1-hydroxyethyl]-2-hydroxybenzyl Alcohol Hemisulfate

57. Albuterol Sulfate [usan]

58. Proair Hfa

59. Ah-3365

60. Einecs 256-916-8

61. Salbutamol Hemisulfate Salt

62. Nsc 289928

63. Accuvent

64. Pediavent

65. Torpex

66. Volare

67. Albuterol Sulfate [usan:usp]

68. Ventolin Nebules

69. Ventolin Sulfate

70. Unii-021sef3731

71. Salbutamol Diskus

72. Salbutamoli Sulfas

73. Buventol Easyhaler

74. Proventil Repetabs

75. Pulvinal Salbutamol

76. Sulbutamol Sulphate

77. Proventil Repetabs, Solution, Syrup, And Tablets

78. Ventolin (tn)

79. Accuneb (tn)

80. Salbutamol Easyhaler

81. Ventolin Easy-breathe

82. Albuterol Sulfate,(s)

83. Albuterol Sulfate (usp)

84. Albuterol Sulfate- Bio-x

85. 1-(4-hydroxy-3-hydroxymethylphenyl)-2-(tert-butylamino)ethanol Sulfate

86. Salbutamol Sulfate (jp17)

87. Tbs-7

88. Schembl33279

89. Alpha(sup 1)-((tert-butylamino)methyl)-4-hydroxy-m-xylene-alpha,alpha'-diol Sulfate (2:1) (salt)

90. Albuterol Sulfate [mi]

91. Chebi:2550

92. (+-)-ysulfate(2:1)(salt)

93. Chembl1441059

94. Salbutamol Sulfate [jan]

95. Albuterol Sulfate [vandf]

96. Dtxsid10881180

97. Hms3263k18

98. Hms3266d17

99. Torpex (albuterol Sulfate)

100. Albuterol Sulfate [usp-rs]

101. Salbutamol Sulfate [mart.]

102. Bis((tert-butyl)(beta,3,4-trihydroxyphenethyl)ammonium) Sulphate

103. Salbutamol Sulfate [who-dd]

104. Salbutamol Sulfate [who-ip]

105. Tox21_501098

106. Mfcd00055200

107. Salbutamol Hemisulfate Salt, >=98%

108. Akos015994719

109. Albuterol Sulfate [green Book]

110. Albuterol Sulfate [orange Book]

111. Ccg-222402

112. Ks-5056

113. Lp01098

114. Tq-1016

115. Albuterol Sulfate [usp Impurity]

116. Salbutamol Sulfate [ep Impurity]

117. Salbutamol Sulphate (albuterol Sulphate)

118. Albuterol Sulfate [usp Monograph]

119. Duoneb Component Albuterol Sulfate

120. Ncgc00094370-01

121. Ncgc00261783-01

122. Salbutamol Sulfate [ep Monograph]

123. 1,3-benzenedimethanol, Alpha(sup 1)-(((1,1-dimethylethyl)amino)methyl)-4-hydroxy-, Sulfate (2:1) (salt)

124. 1,3-benzenedimethanol, Alpha1-(((1,1-dimethylethyl)amino)methyl)-4-hydroxy-, Sulfate (2:1) (salt)

125. Ba164388

126. Salbutamoli Sulfas [who-ip Latin]

127. Combivent Component Albuterol Sulfate

128. Albuterol Sulfate Component Of Duoneb

129. Eu-0101098

130. Ft-0650809

131. S0531

132. Salbutamol Sulfate 100 Microg/ml In Methanol

133. A51088

134. Albuterol Sulfate Component Of Combivent

135. D00683

136. S 5013

137. 022s709

138. A828402

139. Q27231480

140. Salbutamol Hemisulfate Salt, Vetranal(tm), Analytical Standard

141. Salbutamol Sulfate, British Pharmacopoeia (bp) Reference Standard

142. Salbutamol Sulfate, European Pharmacopoeia (ep) Reference Standard

143. Albuterol Sulfate, United States Pharmacopeia (usp) Reference Standard

144. Albuterol Sulfate, Pharmaceutical Secondary Standard; Certified Reference Material

145. Salbutamol Sulfate For System Suitability, European Pharmacopoeia (ep) Reference Standard

146. Salbutamol Sulphate (albuterol Sulphate) 1.0 Mg/ml In Methanol (as Free Base)

147. (+/-)-2-tert-butylamino-1-(4-hydroxy-3-hydroxymethylphenyl)ethanol Sulfate Salt (2:1)

148. .alpha.(sup 1)-((tert-butylamino)methyl)-4-hydroxy-m-xylene-.alpha.,.alpha.'-diol Sulfate (2:1) (salt)

149. .alpha.(sup 1)-((tert-butylamino)methyl)-4-hydroxy-m-xylene-.alpha.,.alpha.'-diol Sulphate (2:1) (salt)

150. 1,3-benzenedimethanol,.alpha.(sup 1)-(((1,1 Dimethylethyl)amino)methyl)-4-hydroxy-, Sulfate (2:1) (salt)

151. 1,3-benzenedimethanol,.alpha.(sup 1)-(((1,1 Dimethylethyl)amino)methyl)-4-hydroxy-, Sulphate (2:1) (salt)

152. 1,3-benzenedimethanol,.alpha.1-(((1,1-dimethylethyl)amino)methyl)-4-hydroxy-, Sulfate (2:1) (salt)

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₂₆H₄₄N₂O₁₀S
Molecular Weight	576.7 g/mol
Hydrogen Bond Donor Count	10
Hydrogen Bond Acceptor Count	12
Rotatable Bond Count	10
Exact Mass	576.27166678 g/mol
Monoisotopic Mass	576.27166678 g/mol
Topological Polar Surface Area	228 Å²
Heavy Atom Count	39
Formal Charge	0
Complexity	309
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	2
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	3

4 Drug and Medication Information

4.1 Drug Information

1 of 12
Drug Name	Accuneb
PubMed Health	Albuterol (By breathing)
Drug Classes	Bronchodilator
Drug Label	Albuterol Sulfate Inhalation Solution is a relatively selective beta2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGY section below). Albuterol sulfate, the racemic form of albuterol, has the chemical name 1-[(tert-Butylamino)methyl]-4-hydroxy...
Active Ingredient	Albuterol sulfate
Dosage Form	Solution
Route	Inhalation
Strength	eq 0.021% base; eq 0.042% base
Market Status	Prescription
Company	Mylan Speclt

2 of 12
Drug Name	Albuterol sulfate
PubMed Health	Albuterol
Drug Classes	Bronchodilator, Cardiovascular Agent
Drug Label	The active component of VENTOLIN HFA is albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta2-adrenergic bronchodilator. Albuterol sulfate has the chemical name 1-[(tert-butylamino)methyl]-4-hydroxy-m-xylene-,...
Active Ingredient	Albuterol sulfate
Dosage Form	Tablet, extended release; Tablet; Syrup; Solution
Route	Inhalation; Oral
Strength	eq 4mg base; eq 0.083% base; eq 2mg base; eq 0.021% base; eq 0.5% base; eq 2mg base/5ml; eq 0.042% base; eq 8mg base
Market Status	Prescription
Company	Watson Labs; Amneal Pharms; Vistapharm; Teva Pharms; Hi Tech Pharma; Ritedose; Actavis Mid Atlantic; Mutual Pharm; Teva; Vintage; Bausch And Lomb; Landela Pharm; Nephron; Mylan Speclt; Mylan

3 of 12
Drug Name	Proair hfa
Active Ingredient	Albuterol sulfate
Dosage Form	Aerosol, metered
Route	Inhalation
Strength	eq 0.09mg base/inh
Market Status	Prescription
Company	Teva Branded Pharm

4 of 12
Drug Name	Proventil-hfa
Active Ingredient	Albuterol sulfate
Dosage Form	Aerosol, metered
Route	Inhalation
Strength	eq 0.09mg base/inh
Market Status	Prescription
Company	3m

5 of 12
Drug Name	Ventolin hfa
Drug Label	Albuterol extended-release tablets contain albuterol sulfate, the racemic form of albuterol and a relatively selective beta2-adrenergic bronchodilator, in an extended-release formulation. Albuterol sulfate has the chemical name () 1-[(tert-butyla...
Active Ingredient	Albuterol sulfate
Dosage Form	Aerosol, metered
Route	Inhalation
Strength	eq 0.09mg base/inh
Market Status	Prescription
Company	Glaxo Grp

6 of 12
Drug Name	Vospire er
Drug Label	The active ingredient of PROAIR HFA (albuterol sulfate) Inhalation Aerosol is albuterol sulfate, a racemic salt, of albuterol. Albuterol sulfate has the chemical name 1-[(tert-butylamino) methyl]-4-hydroxy-m-xylene-,'-diol sulfate (2:1) (salt),...
Active Ingredient	Albuterol sulfate
Dosage Form	Tablet, extended release
Route	Oral
Strength	eq 4mg base; eq 8mg base
Market Status	Prescription
Company	Dava Pharms

7 of 12
Drug Name	Accuneb
PubMed Health	Albuterol (By breathing)
Drug Classes	Bronchodilator
Drug Label	Albuterol Sulfate Inhalation Solution is a relatively selective beta2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGY section below). Albuterol sulfate, the racemic form of albuterol, has the chemical name 1-[(tert-Butylamino)methyl]-4-hydroxy...
Active Ingredient	Albuterol sulfate
Dosage Form	Solution
Route	Inhalation
Strength	eq 0.021% base; eq 0.042% base
Market Status	Prescription
Company	Mylan Speclt

8 of 12
Drug Name	Albuterol sulfate
PubMed Health	Albuterol
Drug Classes	Bronchodilator, Cardiovascular Agent
Drug Label	The active component of VENTOLIN HFA is albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta2-adrenergic bronchodilator. Albuterol sulfate has the chemical name 1-[(tert-butylamino)methyl]-4-hydroxy-m-xylene-,...
Active Ingredient	Albuterol sulfate
Dosage Form	Tablet, extended release; Tablet; Syrup; Solution
Route	Inhalation; Oral
Strength	eq 4mg base; eq 0.083% base; eq 2mg base; eq 0.021% base; eq 0.5% base; eq 2mg base/5ml; eq 0.042% base; eq 8mg base
Market Status	Prescription
Company	Watson Labs; Amneal Pharms; Vistapharm; Teva Pharms; Hi Tech Pharma; Ritedose; Actavis Mid Atlantic; Mutual Pharm; Teva; Vintage; Bausch And Lomb; Landela Pharm; Nephron; Mylan Speclt; Mylan

9 of 12
Drug Name	Proair hfa
Active Ingredient	Albuterol sulfate
Dosage Form	Aerosol, metered
Route	Inhalation
Strength	eq 0.09mg base/inh
Market Status	Prescription
Company	Teva Branded Pharm

10 of 12
Drug Name	Proventil-hfa
Active Ingredient	Albuterol sulfate
Dosage Form	Aerosol, metered
Route	Inhalation
Strength	eq 0.09mg base/inh
Market Status	Prescription
Company	3m

11 of 12
Drug Name	Ventolin hfa
Drug Label	Albuterol extended-release tablets contain albuterol sulfate, the racemic form of albuterol and a relatively selective beta2-adrenergic bronchodilator, in an extended-release formulation. Albuterol sulfate has the chemical name () 1-[(tert-butyla...
Active Ingredient	Albuterol sulfate
Dosage Form	Aerosol, metered
Route	Inhalation
Strength	eq 0.09mg base/inh
Market Status	Prescription
Company	Glaxo Grp

12 of 12
Drug Name	Vospire er
Drug Label	The active ingredient of PROAIR HFA (albuterol sulfate) Inhalation Aerosol is albuterol sulfate, a racemic salt, of albuterol. Albuterol sulfate has the chemical name 1-[(tert-butylamino) methyl]-4-hydroxy-m-xylene-,'-diol sulfate (2:1) (salt),...
Active Ingredient	Albuterol sulfate
Dosage Form	Tablet, extended release
Route	Oral
Strength	eq 4mg base; eq 8mg base
Market Status	Prescription
Company	Dava Pharms

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Adrenergic beta-2 Receptor Agonists

Compounds bind to and activate ADRENERGIC BETA-2 RECEPTORS. (See all compounds classified as Adrenergic beta-2 Receptor Agonists.)

Tocolytic Agents

Drugs that prevent preterm labor and immature birth by suppressing uterine contractions (TOCOLYSIS). Agents used to delay premature uterine activity include magnesium sulfate, beta-mimetics, oxytocin antagonists, calcium channel inhibitors, and adrenergic beta-receptor agonists. The use of intravenous alcohol as a tocolytic is now obsolete. (See all compounds classified as Tocolytic Agents.)

Bronchodilator Agents

Agents that cause an increase in the expansion of a bronchus or bronchial tubes. (See all compounds classified as Bronchodilator Agents.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

beta2-Adrenergic Agonist [EPC]; Adrenergic beta2-Agonists [MoA]

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