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ACTIVE PHARMA INGREDIENTS

37 API Suppliers, 17 USDMF, 5 CEP/COS, 6 JDMF, 2 EU WC, 7 KDMF, 14 NDC API, 12 Listed Suppliers, $ API Reference Price

37 API Suppliers
17 USDMF
5 CEP/COS
6 JDMF
2 EU WC
7 KDMF
14 NDC API
12 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

5 Drugs in Development

5 Drugs in Development

FINISHED DOSAGE FORMULATIONS

295 FDF Dossiers, 113 FDA Orange Book, 87 Europe, 32 Canada, 2 Australia, 39 South Africa, 22 Listed Dossiers

295 FDF Dossiers
113 FDA Orange Book
87 Europe
32 Canada
2 Australia
39 South Africa
22 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;IRRIGATION - 0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML, FOR SOLUTION;ORAL - 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT, INJECTABLE;INJECTION - 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML), INJECTABLE;INJECTION - N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML), INJECTABLE;INJECTION - 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML), INJECTABLE;INJECTION - 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML), INJECTABLE;INJECTION - 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML), INJECTABLE;INJECTION - 5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML), INJECTABLE;INJECTION - 5.15GM/1000ML;N/A/1000ML;5.4GM/1000ML;2.03GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML), INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML), INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.44GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML), INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML), INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML), INJECTABLE;INJECTION - N/A/1000ML;N/A/1000ML;5.4GM/1000ML;2.44GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML), CAPSULE;ORAL - 20MG;1.1GM, CAPSULE;ORAL - 40MG;1.1GM, CAPSULE;ORAL - 20MG;1.1GM

drugProductComposition
SOLUTION;IRRIGATION - 0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML
FOR SOLUTION;ORAL - 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT
INJECTABLE;INJECTION - 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML)
INJECTABLE;INJECTION - N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML)
INJECTABLE;INJECTION - 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)
INJECTABLE;INJECTION - 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)
INJECTABLE;INJECTION - 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)
INJECTABLE;INJECTION - 5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)
INJECTABLE;INJECTION - 5.15GM/1000ML;N/A/1000ML;5.4GM/1000ML;2.03GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)
INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)
INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.44GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)
INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)
INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)
INJECTABLE;INJECTION - N/A/1000ML;N/A/1000ML;5.4GM/1000ML;2.44GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)
CAPSULE;ORAL - 20MG;1.1GM
CAPSULE;ORAL - 40MG;1.1GM
CAPSULE;ORAL - 20MG;1.1GM

RELATED EXCIPIENT COMPANIES

1 Minakem, 11 Rochem International Inc, 25 SPI Pharma, 11 DKSH, 3 Jai Radhe Sales, 2 Pharm-RX Chemical, 8 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 14 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 11 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 21 BASF, 2 Bioplus Life Sciences, 1 Clariant, 5 Corel Pharma Chem, 3 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 4 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 10 Kerry, 3 Lonza Capsugel, 12 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 9 Pluviaendo, 4 Prachin Chemical, 1 Qualicaps, 26 Roquette, 10 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

relatedExcipients
1 Minakem
11 Rochem International Inc
25 SPI Pharma
11 DKSH
3 Jai Radhe Sales
2 Pharm-RX Chemical
8 Faran Shimi Pharmaceutical
1 Boai NKY Pharmaceuticals Ltd
1 Chynops Pharma
14 Gangwal Healthcare
4 Nanjing Well Pharmaceutical
2 Pfanstiehl
4 ACG Worldwide
11 Actylis
1 Aeon Procare
1 Alcedo Pharmachem
8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
1 Avesta Pharma
21 BASF
2 Bioplus Life Sciences
1 Clariant
5 Corel Pharma Chem
3 DFE Pharma
2 Finar
11 Gangwal Chemicals
4 Ideal Cures Pvt Ltd
4 Ingredion Pharma Solutions
10 Kerry
3 Lonza Capsugel
12 Microlex e.U
1 Nanjing Bold Chemical
1 NEWEDGE Overseas
2 Novo Excipients
3 Pharmatrans-Sanaq
9 Pluviaendo
4 Prachin Chemical
1 Qualicaps
26 Roquette
10 Seppic
5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shijiazhuang Huaxu Pharmaceutical
10 Sigachi Industries
1 Ulanqab Kema New Material
1 Valens Pharmachem
4 Vasa Pharmachem
1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

77 Fillers, Diluents & Binders, 40 Direct Compression, 32 Coating Systems & Additives, 32 Thickeners and Stabilizers, 31 Taste Masking, 30 Solubilizers, 25 Disintegrants & Superdisintegrants, 25 Lubricants & Glidants, 23 Parenteral, 23 Granulation, 21 Chewable & Orodispersible Aids, 19 Co-Processed Excipients, 17 Topical, 16 Controlled & Modified Release, 13 Film Formers & Plasticizers, 10 Emulsifying Agents, 8 Empty Capsules, 6 API Stability Enhancers, 6 Surfactant & Foaming Agents, 5 Rheology Modifiers, 3 Coloring Agents

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 61 NEWS #PharmaBuzz

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2 DATA COMPILATION #PharmaFlow
61 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 78 Finished Drug Prices

globalSalesInformation
3 US Medicaid Prescriptions
78 Finished Drug Prices

MARKET PLACE

41 APIs, 10 FDF Dossiers, 2 EXCIPIENTS, 1 Intermediates

marketPlace
41 APIs
10 FDF Dossiers
2 EXCIPIENTS
1 Intermediates

PATENTS & EXCLUSIVITIES

7 US Patents

patents
7 US Patents

REF. STANDARDS & IMPURITIES

2 USP , 1 Others

otherSolutions
2 USP
1 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 164

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

295

FDF Dossiers

113

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

5DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

1,131,607

Annual Reports (USD Million)

Finished Drug Prices

267 RELATED EXCIPIENT COMPANIES

462EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Sodium hydrogen carbonate, 144-55-8, Baking soda, Sodium hydrogencarbonate, Sodium acid carbonate, Carbonic acid monosodium salt

Molecular Formula

CHNaO₃

Molecular Weight

84.007 g/mol

InChI Key

UIIMBOGNXHQVGW-UHFFFAOYSA-M

FDA UNII

8MDF5V39QO

A white, crystalline powder that is commonly used as a pH buffering agent, an electrolyte replenisher, systemic alkalizer and in topical cleansing solutions.

1 2D Structure

Sodium Bicarbonate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

sodium;hydrogen carbonate

2.1.2 InChI

InChI=1S/CH2O3.Na/c2-1(3)4;/h(H2,2,3,4);/q;+1/p-1

2.1.3 InChI Key

UIIMBOGNXHQVGW-UHFFFAOYSA-M

2.1.4 Canonical SMILES

C(=O)(O)[O-].[Na+]

2.2 Other Identifiers

2.2.1 UNII

8MDF5V39QO

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Baking Soda

2. Bicarbonate, Sodium

3. Carbonic Acid Monosodium Salt

4. Hydrogen Carbonate, Sodium

5. Soda, Baking

6. Sodium Hydrogen Carbonate

2.3.2 Depositor-Supplied Synonyms

1. Sodium Hydrogen Carbonate

2. 144-55-8

3. Baking Soda

4. Sodium Hydrogencarbonate

5. Sodium Acid Carbonate

6. Carbonic Acid Monosodium Salt

7. Bicarbonate Of Soda

8. Sodium Hydrocarbonate

9. Monosodium Carbonate

10. Meylon

11. Acidosan

12. Neut

13. Natriumhydrogenkarbonat

14. Nahco3

15. Natrum Bicarbonicum

16. Jusonin

17. Soludal

18. Soda Mint

19. Soda (van)

20. Carbonic Acid Sodium Salt (1:1)

21. Monosodium Hydrogen Carbonate

22. Nabic

23. Mfcd00003528

24. Sodium Hydrogencarbonat

25. Hydrocerol Esc 5671

26. Carbonic Acid, Monosodium Salt

27. Genitron Tp-bch 51051

28. Sodium Bicarbonate Anhydrous

29. 8mdf5v39qo

30. E500

31. Ins No.500(ii)

32. Chebi:32139

33. Ins-500(ii)

34. Col-evac

35. Sel De Vichy

36. E-500(ii)

37. Nsc-134031

38. Natrium Bicarbonicum

39. Natrii Hydrogencarbonas

40. E 500

41. E-500

42. Natrium Hydrogencarbonicum

43. Sodium Hydrogen-carbonate

44. Caswell No. 747

45. Sodium Carbonate (na(hco3))

46. Sodium Bicarbonate (1:1)

47. Sodium Bicarbonate In Plastic Container

48. Meylon (tn)

49. Ccris 3064

50. Hsdb 697

51. Neut (tn)

52. Sodium;hydrogen Carbonate

53. Einecs 205-633-8

54. Sodium Bicarbonate Solution

55. Unii-8mdf5v39qo

56. Epa Pesticide Chemical Code 073505

57. Nsc 134031

58. Sodium Bicarbonate [usp:jan]

59. Sodium Bicabonate

60. Sodium Bicarbonat

61. Bicarbonate Sodium

62. Sodium-bicarbonate

63. Sodiumbi-carbonate

64. Sodium Bi-carbonate

65. Sodium Bicarbonate-

66. Sodium Bi Carbonate

67. Natriumhydrogencarbonat

68. Sodium Hydrogencabonate

69. Sodium;hydron;carbonate

70. Sodiumhydrogen Carbonate

71. Natrii Hydrogenocarbonas

72. Sodium Hydrogen Cabonate

73. Hydrogen Carbonate Sodium

74. Sodium Bicarbonate, Usp

75. Sodium Hyd-rogencarbonate

76. Sodium-hydrogen-carbonate

77. Sodium Hydrogen Carboante

78. Sodium Bicarboniate

79. Ec 205-633-8

80. Chembl1353

81. B1654 [langual]

82. Sodium Bicarbonate [ii]

83. Sodium Bicarbonate [mi]

84. Dtxsid9021269

85. Sodium Bicarbonate [fcc]

86. Sodium Bicarbonate [jan]

87. Sodium Bicarbonate (jp17/usp)

88. Sodium Bicarbonate [hsdb]

89. Sodium Bicarbonate [inci]

90. Sodium Hydrogen Carbonate Solution

91. Natrum Bicarbonicum [hpus]

92. Sodium Bicarbonate [vandf]

93. Sodium Bicarbonate [mart.]

94. Amy40219

95. Sodium Bicarbonate [usp-rs]

96. Sodium Bicarbonate [who-dd]

97. Str00078

98. Sodium Bicarbonate -40-+140 Mesh

99. Sodium Bicarbonate, Biochemical Grade

100. Akos015836321

101. Akos015951222

102. Sodium Hydrogen Carbonate, Puratronic?

103. Db01390

104. Sodium Bicarbonate [orange Book]

105. Baros Component Sodium Bicarbonate

106. Sodium Bicarbonate A.c.s. Reagent Grade

107. Sodium Bicarbonate [usp Monograph]

108. Bicarbonate, 1m Buffer Solution, Ph 8.0

109. Bicarbonate, 1m Buffer Solution, Ph 8.5

110. Sodium Hydrogen Carbonate [who-ip]

111. Zegerid Component Sodium Bicarbonate

112. B7292

113. Ft-0645108

114. Normocarb Component Sodium Bicarbonate

115. S0561

116. Sodium Bicarbonate Component Of Baros

117. Halflytely Component Sodium Bicarbonate

118. Sodium Bicarbonate Component Of Zegerid

119. D01203

120. Natrii Hydrogenocarbonas [who-ip Latin]

121. 3-phenyl-2-thioxotetrahydropyrimidin-4(1h)-one

122. Sodium Bicarbonate Component Of Halflytely

123. Sodium Bicarbonate Component Of Normocarb

124. Sodium Bicarbonate, 1m Buffer Solution, Ph 8.0

125. Sodium Bicarbonate, 1m Buffer Solution, Ph 9.0

126. Sodium Hydrogen Carbonate [ep Monograph]

127. Q179731

128. Sodium Bicarbonate, 1m Buffer Solution, Ph 10.0

129. Sodium Bicarbonate, Hplc, Meets Acs Specifications

130. Sodium Bicarbonate 5% W/v Solution In Water (+/- 0.3%)

131. Saturated Aqueous Sodium Bicarbonate Solution (~9.6% Wt/wt)

2.4 Create Date

2005-03-27

3 Chemical and Physical Properties

Molecular Formula	CHNaO₃
Molecular Weight	84.007 g/mol
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	3
Rotatable Bond Count	0
Exact Mass	83.98233817 g/mol
Monoisotopic Mass	83.98233817 g/mol
Topological Polar Surface Area	60.4 Å²
Heavy Atom Count	5
Formal Charge	0
Complexity	33.9
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
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 8
Drug Name	Bss plus
Active Ingredient	sodium chloride; sodium phosphate; magnesium chloride; potassium chloride; glutathione disulfide; sodium bicarbonate; dextrose; Calcium chloride
Dosage Form	Solution
Route	Irrigation
Strength	0.2mg/ml; 0.38mg/ml; 0.184mg/ml; 0.92mg/ml; 2.1mg/ml; 0.154mg/ml; 0.42mg/ml; 7.14mg/ml
Market Status	Prescription
Company	Alcon

2 of 8
Drug Name	Golytely
PubMed Health	Sodium Bicarbonate
Drug Classes	Antacid, Sodium Bicarbonate Containing
Active Ingredient	sodium chloride; sodium bicarbonate; Polyethylene glycol 3350; sodium sulfate anhydrous; potassium chloride
Dosage Form	For solution
Route	Oral
Strength	5.86gm/bot; 227.1gm/packet; 6.74gm/bot; 2.82gm/packet; 22.74gm/bot; 21.5gm/packet; 2.97gm/bot; 5.53gm/packet; 6.36gm/packet; 236gm/bot
Market Status	Prescription
Company	Braintree

3 of 8
Drug Name	Nulytely
Active Ingredient	sodium chloride; sodium bicarbonate; Polyethylene glycol 3350; potassium chloride
Dosage Form	For solution
Route	Oral
Strength	420gm/bot; 1.48gm/bot; 11.2gm/bot; 5.72gm/bot
Market Status	Prescription
Company	Braintree

4 of 8
Drug Name	Sodium bicarbonate
PubMed Health	Polyethylene Glycol 3350, Sodium and Potassium Salts (Oral route)
Drug Classes	Laxative, Hyperosmotic
Drug Label	Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO3) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer.Solutions are off...
Active Ingredient	Sodium bicarbonate
Dosage Form	Injectable
Route	Injection
Strength	0.9meq/ml; 1meq/ml
Market Status	Prescription
Company	Hospira

5 of 8
Drug Name	Bss plus
Active Ingredient	sodium chloride; sodium phosphate; magnesium chloride; potassium chloride; glutathione disulfide; sodium bicarbonate; dextrose; Calcium chloride
Dosage Form	Solution
Route	Irrigation
Strength	0.2mg/ml; 0.38mg/ml; 0.184mg/ml; 0.92mg/ml; 2.1mg/ml; 0.154mg/ml; 0.42mg/ml; 7.14mg/ml
Market Status	Prescription
Company	Alcon

6 of 8
Drug Name	Golytely
PubMed Health	Sodium Bicarbonate
Drug Classes	Antacid, Sodium Bicarbonate Containing
Active Ingredient	sodium chloride; sodium bicarbonate; Polyethylene glycol 3350; sodium sulfate anhydrous; potassium chloride
Dosage Form	For solution
Route	Oral
Strength	5.86gm/bot; 227.1gm/packet; 6.74gm/bot; 2.82gm/packet; 22.74gm/bot; 21.5gm/packet; 2.97gm/bot; 5.53gm/packet; 6.36gm/packet; 236gm/bot
Market Status	Prescription
Company	Braintree

7 of 8
Drug Name	Nulytely
Active Ingredient	sodium chloride; sodium bicarbonate; Polyethylene glycol 3350; potassium chloride
Dosage Form	For solution
Route	Oral
Strength	420gm/bot; 1.48gm/bot; 11.2gm/bot; 5.72gm/bot
Market Status	Prescription
Company	Braintree

8 of 8
Drug Name	Sodium bicarbonate
PubMed Health	Polyethylene Glycol 3350, Sodium and Potassium Salts (Oral route)
Drug Classes	Laxative, Hyperosmotic
Drug Label	Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO3) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer.Solutions are off...
Active Ingredient	Sodium bicarbonate
Dosage Form	Injectable
Route	Injection
Strength	0.9meq/ml; 1meq/ml
Market Status	Prescription
Company	Hospira

4.2 Therapeutic Uses

Sodium bicarbonate is used in the treatment of metabolic acidosis associated with many conditions including severe renal disease (e.g., renal tubular acidosis), uncontrolled diabetes (ketoacidosis), extracorporeal circulation of the blood, cardiac arrest, circulatory insufficiency caused by shock or severe dehydration, ureterosigmoidostomy, lactic acidosis, alcoholic ketoacidosis, use of carbonic anhydrase inhibitors, and ammonium chloride administration. In metabolic acidosis, the principal disturbance is a loss of proton acceptors (e.g., loss of bicarbonate during severe diarrhea) or accumulation of an acid load (e.g., ketoacidosis, lactic acidosis, renal tubular acidosis).

American Society of Health-System Pharmacists 2017; Drug Information 2017. Bethesda, MD. 2017, p. 2852

The specific role of sodium bicarbonate therapy in the treatment of diabetic ketoacidosis has not been established. Because correction of the underlying metabolic disorder generally results in correction of acid-base abnormalities and because of the potential risks of sodium bicarbonate therapy in the treatment of this disorder, administration of sodium bicarbonate is generally reserved for the treatment of severe acidosis (e.g., arterial pH less than 7-7.15 or serum bicarbonate concentration of 8 mEq/L or less). Rapid correction of acidosis with sodium bicarbonate in patients with diabetic ketoacidosis may cause hypokalemia, paradoxical acidosis in cerebrospinal fluid (CSF) since carbon dioxide diffuses more rapidly into CSF than does bicarbonate, and lactic acidosis since increased pH increases hemoglobin-oxygen affinity which, when combined with erythrocyte 2,3-diphosphoglycerate (2,3-DPG) deficiency in these patients, results in peripheral tissue hypoxia. However, the benefits and risks of sodium bicarbonate therapy in ketoacidosis have not been fully determined, and additional controlled studies of the safety and efficacy of the drug are necessary. Generally, when sodium bicarbonate is used in the treatment of diabetic ketoacidosis, the acidosis should only be partially corrected (e.g., to an arterial pH of about 7.2) to avoid rebound metabolic alkalosis as ketones are metabolized.

American Society of Health-System Pharmacists 2017; Drug Information 2017. Bethesda, MD. 2017, p. 2852

Oral sodium bicarbonate is indicated to reduce uric acid crystallization as an adjuvant to uricosuric medication in gout. /Included in US product labeling/

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006.

Parenteral sodium bicarbonate is indicated in the treatment of certain drug intoxications, including barbiturates, and in poisoning by salicylates or methyl alcohol. /Included in US product labeling/

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006.

For more Therapeutic Uses (Complete) data for Sodium bicarbonate (29 total), please visit the HSDB record page.

4.3 Drug Warning

Sodium bicarbonate is generally contraindicated in patients with metabolic or respiratory alkalosis, in patients with hypocalcemia in whom alkalosis may induce tetany, in patients with excessive chloride loss from vomiting or continuous GI suctioning, and in patients at risk of developing diuretic-induced hypochloremic alkalosis. Sodium bicarbonate should not be used orally as an antidote in the treatment of acute ingestion of strong mineral acids, since carbon dioxide gas forms during neutralization and may cause gastric distention and possible rupture.

American Society of Health-System Pharmacists 2017; Drug Information 2017. Bethesda, MD. 2017, p. 2853

Sodium bicarbonate should be used with extreme caution in patients with congestive heart failure or other edematous or sodium-retaining conditions; in patients with renal insufficiency, especially those with severe insufficiency such as oliguria or anuria; and in patients receiving corticosteroids or corticotropin, since each gram of sodium bicarbonate contains about 12 mEq of sodium. IV administration of sodium bicarbonate may cause fluid and/or solute overload resulting in dilution of serum electrolytes, overhydration, congestive conditions, or pulmonary edema. The risk of dilutional conditions is inversely proportional to the electrolyte concentration administered, and the risk of solute overload and resultant congestive conditions with peripheral and/or pulmonary edema is directly proportional to the electrolyte concentration administered.

American Society of Health-System Pharmacists 2017; Drug Information 2017. Bethesda, MD. 2017, p. 2853

Gastric distention and flatulence may occur when sodium bicarbonate is administered orally. Inadvertent extravasation of hypertonic solutions of sodium bicarbonate has reportedly caused chemical cellulitis because of their alkalinity, subsequently resulting in tissue necrosis, ulceration, and/or sloughing at the site of injection.

American Society of Health-System Pharmacists 2017; Drug Information 2017. Bethesda, MD. 2017, p. 2853

Predisposing factors /contributing to milk-alkali syndrome/ are preexisting hypertension, sarcoidosis, dehydration and electrolyte imbalance due to vomiting or aspiration of gastric contents with inadequate iv fluid replacement, and renal dysfunction caused by primary renal disease.

American Medical Association, Council on Drugs. AMA Drug Evaluations Annual 1994. Chicago, IL: American Medical Association, 1994., p. 909

For more Drug Warnings (Complete) data for Sodium bicarbonate (14 total), please visit the HSDB record page.

4.4 Drug Indication

Sodium bicarbonate is used for the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate. Further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturateprotein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of blood pigments.

5 Pharmacology and Biochemistry

5.1 Pharmacology

Intravenous sodium bicarbonate therapy increases plasma bicarbonate, buffers excess hydrogen ion concentration, raises blood pH and reverses the clinical manifestations of acidosis.

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Osmotic Activity [MoA]; Osmotic Laxative [EPC]; Alkalinizing Activity [MoA]; Increased Large Intestinal Motility [PE]

5.3 ATC Code

B - Blood and blood forming organs

B05 - Blood substitutes and perfusion solutions

B05C - Irrigating solutions

B05CB - Salt solutions

B05CB04 - Sodium bicarbonate

B - Blood and blood forming organs

B05 - Blood substitutes and perfusion solutions

B05X - I.v. solution additives

B05XA - Electrolyte solutions

B05XA02 - Sodium bicarbonate

5.4 Absorption, Distribution and Excretion

Elimination: Renal; carbon dioxide formed is eliminated via lungs.

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006.

Excess sodium bicarbonate is emptied rapidly into small intestine where it is absorbed.

Miller, R. R., and D. J. Greenblatt. Handbook of Drug Therapy. New York: Elsevier North Holland, 1979., p. 1043

It is eliminated principally in the urine and effectively alkalizes it. ... /It/ is completely absorbed orally and usually is excreted within 3-4 hr.

American Medical Association, AMA Department of Drugs. AMA Drug Evaluations. 4th ed. Chicago: American Medical Association, 1980., p. 1440

Oral: Onset of action: Rapid; Duration: 8-10 minutes. I.V: Onset of action: 15 minutes; duration: 1-2 hours.

Lelkin, J.B., Paloucek, F.P., Poisoning & Toxicology Compendium. LEXI-COMP Inc. & American Pharmaceutical Association, Hudson, OH 1998., p. 1079

For more Absorption, Distribution and Excretion (Complete) data for Sodium bicarbonate (8 total), please visit the HSDB record page.

5.5 Metabolism/Metabolites

Excessive use can cause systemic alkalosis /in animals/, but body usually splits bicarbonate radical into water and carbon dioxide ...

Rossoff, I.S. Handbook of Veterinary Drugs. New York: Springer Publishing Company, 1974., p. 533

Sodium bicarbonate rapidly reacts with hydrochloric acid to form sodium chloride, carbon dioxide, and water; excess bicarbonate that does not neutralize gastric acid rapidly empties into the small intestine and is absorbed.

McEvoy, G.K. (ed.). American Hospital Formulary Service--Drug Information 94. Bethesda, MD: American Society of Hospital Pharmacists, Inc. 1994 (Plus Supplements)., p. 1870

5.6 Mechanism of Action

Sodium bicarbonate is a systemic alkalizer, which increases plasma bicarbonate, buffers excess hydrogen ion concentration, and raises blood pH, thereby reversing the clinical manifestations of acidosis. It is also a urinary alkalizer, increasing the excretion of free bicarbonate ions in the urine, thus effectively raising the urinary pH. By maintaining an alkaline urine, the actual dissolution of uric acid stones may be accomplished. Sodium bicarbonate acts as an antacid and reacts chemically to neutralize or buffer existing quantities of stomach acid but has no direct effect on its output. This action results in increased pH value of stomach contents, thus providing relief of hyperacidity symptoms. [PharmGKB]

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01

EMNAR PHARMA PRIVATE LIMITED Hydera...

India

euroPLX 86 Munich

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02

NOVABAY Pte. Ltd Singapore SG

France

euroPLX 86 Munich

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03

Solvay Quimica, S.L. Martorell ES

Belgium

euroPLX 86 Munich

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04

SOLVAY OPERATIONS FRANCE Paris FR

Italy

euroPLX 86 Munich

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05

SOLVAY PEROXYTHAI LIMITED Rayong TH

Italy

euroPLX 86 Munich

Not Confirmed

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API Reference Price

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DOSAGE - SOLUTION;IRRIGATION - 0.154MG/ML;0.9...DOSAGE - SOLUTION;IRRIGATION - 0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML

USFDA APPLICATION NUMBER - 18469

DOSAGE - FOR SOLUTION;ORAL - 420GM/BOT;1.48GM...DOSAGE - FOR SOLUTION;ORAL - 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT

USFDA APPLICATION NUMBER - 19797

DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML...DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML)

USFDA APPLICATION NUMBER - 207026

DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;3....DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML)

USFDA APPLICATION NUMBER - 207026

DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML...DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)