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323 FDF Dossiers, 96 FDA Orange Book, 158 Europe, 33 Canada, 36 South Africa

323 FDF Dossiers
96 FDA Orange Book
158 Europe
33 Canada
36 South Africa

DRUG PRODUCT COMPOSITIONS

EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1440ML), EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1920ML), EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML ;105MG/100ML;3.5GM/100ML (2400ML), EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML ;147MG/100ML;3.9GM/100ML (1026ML), EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (1540ML), EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2053ML), EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2566ML), SOLUTION;IRRIGATION - 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML

drugProductComposition
EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1440ML)
EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1920ML)
EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML ;105MG/100ML;3.5GM/100ML (2400ML)
EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML ;147MG/100ML;3.9GM/100ML (1026ML)
EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (1540ML)
EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2053ML)
EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2566ML)
SOLUTION;IRRIGATION - 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML

RELATED EXCIPIENT COMPANIES

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1 US Medicaid Prescriptions, 158 Finished Drug Prices

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158 Finished Drug Prices

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Synopsis

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158

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134 RELATED EXCIPIENT COMPANIES

220EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 127-09-3, Acetic acid, sodium salt, Sodium acetate anhydrous, Acetic acid sodium salt, Sodium acetate, anhydrous, Anhydrous sodium acetate

Molecular Formula

C₂H₃NaO₂

Molecular Weight

82.03 g/mol

InChI Key

VMHLLURERBWHNL-UHFFFAOYSA-M

FDA UNII

NVG71ZZ7P0

The trihydrate sodium salt of acetic acid, which is used as a source of sodium ions in solutions for dialysis and as a systemic and urinary alkalizer, diuretic, and expectorant.

1 2D Structure

Sodium Acetate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

sodium;acetate

2.1.2 InChI

InChI=1S/C2H4O2.Na/c1-2(3)4;/h1H3,(H,3,4);/q;+1/p-1

2.1.3 InChI Key

VMHLLURERBWHNL-UHFFFAOYSA-M

2.1.4 Canonical SMILES

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

2.2 Other Identifiers

2.2.1 UNII

NVG71ZZ7P0

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Sodium Acetate Trihydrate

2. Sodium Acetate, Anhydrous

2.3.2 Depositor-Supplied Synonyms

1. 127-09-3

2. Acetic Acid, Sodium Salt

3. Sodium Acetate Anhydrous

4. Acetic Acid Sodium Salt

5. Sodium Acetate, Anhydrous

6. Anhydrous Sodium Acetate

7. Sodium Ethanoate

8. Fema No. 3024

9. Sodium-acetate

10. Acetic Acid, Sodium Salt (1:1)

11. Sodium;acetate

12. Mfcd00012459

13. Natriumacetat

14. Sodium Acetate,anhydrous

15. Nvg71zz7p0

16. Chebi:32954

17. Sodii Acetas

18. Natriumazetat

19. Nsc-77459

20. Natrium Aceticum

21. Octan Sodny [czech]

22. Caswell No. 741a

23. Natriumacetat [german]

24. Chembl1354

25. Fema Number 3024

26. Octan Sodny

27. Naoac

28. Hsdb 688

29. Sodium Acetate In Plastic Container

30. Einecs 204-823-8

31. Nsc 77459

32. Unii-nvg71zz7p0

33. Epa Pesticide Chemical Code 044006

34. Sodiumacetate

35. Sodium Aceate

36. Acona

37. Scfa

38. Ch3coona

39. Acetic Acidsodium Salt

40. Sodium Acetate Solution

41. Short Chain Fatty Acids

42. Sodium Acetate ,(s)

43. Ch3co2na

44. Dsstox_cid_7044

45. Ec 204-823-8

46. Dsstox_rid_78290

47. Sodium Acetate [mi]

48. Dsstox_gsid_27044

49. Sodium Acetate, Acs Reagent

50. Sodium Acetate [fhfi]

51. Sodium Acetate [hsdb]

52. Dtxsid2027044

53. Sodium Acetate [who-dd]

54. Sodium Acetate Solution, 0.3 M

55. Sodium Acetate, Biochemical Grade

56. Sodium Acetate Anhydrous Acs Usp

57. Tox21_202741

58. Sodium Acetate Anhydrous [ii]

59. Akos003052995

60. Akos015837569

61. Sodium Acetate, Bioxtra, >=99.0%

62. Db09395

63. Sodium Acetate, Reagentplus(r), 99%

64. Sodium Acetate, For Hplc, >=99.5%

65. Sodium Acetate,anhydrous [vandf]

66. Acetate, 1m Buffer Solution, Ph, 3.0

67. Acetate, 1m Buffer Solution, Ph, 3.5

68. Acetate, 1m Buffer Solution, Ph, 4.0

69. Acetate, 1m Buffer Solution, Ph, 5.0

70. Acetate, 1m Buffer Solution, Ph, 5.5

71. Ncgc00260289-01

72. Sodium Acetate, Ar, Anhydrous, >=99%

73. Sodium Acetate, Lr, Anhydrous, >=98%

74. Cas-127-09-3

75. E262

76. Sodium Acetate, Acs Reagent, >=99.0%

77. B7296

78. Ft-0635282

79. Ft-0659959

80. Ft-0689166

81. S0559

82. Sodium Acetate Anhydrous, >99%, Fcc, Fg

83. Sodium Acetate Anhydrous [orange Book]

84. Sodium Acetate, 99.995% Trace Metals Basis

85. Sodium Acetate, Saj First Grade, >=98.0%

86. Sodium Acetate, Trace Metals Grade, 99.99%

87. Sodium Acetate Anhydrous Acs Grade 12kg

88. Sodium Acetate, Jis Special Grade, >=98.5%

89. Sodium Acetate, Vetec(tm) Reagent Grade, 98%

90. Sodium Acetate Anhydrous [usp Monograph]

91. A805637

92. Q339940

93. J-005463

94. Sodium Acetate, For Hplc, 99.0-101.0% (nt)

95. Sodium Acetate, Puriss., Anhydrous, >=98%, Powder

96. Sodium Acetate, Anhydrous, Reagentplus(r), >=99.0%

97. Sodium Acetate, Anhydrous, For Molecular Biology, >=99%

98. Sodium Acetate, For Electrophoresis, >=99%, Crystalline

99. Sodium Acetate, 1m Aqueous Solution, Ph 4.5, Rnase Free

100. Sodium Acetate, 3m Aqueous Solution, Ph 4.5, Autoclaved

101. Sodium Acetate, 3m Aqueous Solution, Ph 5.2, Autoclaved

102. Sodium Acetate, 3m Aqueous Solution, Ph 5.2, Rnase Free

103. Sodium Acetate, 3m Aqueous Solution, Ph 7.0, Autoclaved

104. Sodium Acetate, 3m Aqueous Solution, Ph 7.0, Rnase Free

105. Sodium Acetate, Meets Usp Testing Specifications, Anhydrous

106. Sodium Acetate, United States Pharmacopeia (usp) Reference Standard

107. Sodium Acetate Solution, Bioultra, For Molecular Biology, ~3 M In H2o

108. Sodium Acetate, Bioultra, For Luminescence, Anhydrous, >=99.0% (nt)

109. Sodium Acetate, Puriss. P.a., Acs Reagent, Reag. Ph. Eur., Anhydrous

110. Sodium Acetate, Anhydrous, Bioultra, For Luminescence, For Molecular Biology, >=99.0% (nt)

111. Sodium Acetate, Anhydrous, Free-flowing, Redi-dri(tm), Acs Reagent, >=99.0%

112. Mettler-toledo Calibration Substance Me 30130599, Sodium Acetate Anhydrous, Tracable To Primary Standards (lgc)

113. Sodium Acetate Solution, Nmr Reference Standard, 50 Mm In D2o (99.9 Atom % D), Water 1 %, Nmr Tube Size 3 Mm X 8 In.

114. Sodium Acetate, Powder, Bioreagent, For Electrophoresis, Suitable For Cell Culture, Suitable For Insect Cell Culture, >=99%

2.4 Create Date

2005-03-27

3 Chemical and Physical Properties

Molecular Formula	C₂H₃NaO₂
Molecular Weight	82.03 g/mol
Hydrogen Bond Donor Count	0
Hydrogen Bond Acceptor Count	2
Rotatable Bond Count	0
Exact Mass	82.00307362 g/mol
Monoisotopic Mass	82.00307362 g/mol
Topological Polar Surface Area	40.1 Å²
Heavy Atom Count	5
Formal Charge	0
Complexity	34.6
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 2
Drug Name	Sodium acetate in plastic container
Active Ingredient	Sodium acetate anhydrous
Dosage Form	Injectable
Route	Injection
Strength	2meq/ml
Market Status	Prescription
Company	Hospira

2 of 2
Drug Name	Sodium acetate in plastic container
Active Ingredient	Sodium acetate anhydrous
Dosage Form	Injectable
Route	Injection
Strength	2meq/ml
Market Status	Prescription
Company	Hospira

4.2 Therapeutic Uses

Diuretics; Expectorants; Pharmaceutic Aids

National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)

/FORMER USE/: HYOSCYAMUS SODIUM ACETATE, & PHENOBARBITAL ELIXIR COMBINES SMOOTH MUSCLE ANTISPASMODIC ACTION OF ... HYOSCYAMUS, WITH URINARY ALKALINIZING & DIURETIC EFFECTS OF SODIUM ACETATE, & SEDATIVE EFFECTS OF PHENOBARBITAL. /IT IS/ USED IN MANAGEMENT OF CYSTITIS & FOR BLADDER IRRITATION.

American Hospital Formulary Service. Volumes I and II. Washington, DC: American Society of Hospital Pharmacists, to 1984., p. 86:00

DOSAGE OF ELIXIR OF HYOSCYAMUS CMPD /CONTAINING SODIUM ACETATE & PHENOBARBITAL/ IS 5 ML GIVEN 3 TIMES DAILY BEFORE MEALS.

American Hospital Formulary Service. Volumes I and II. Washington, DC: American Society of Hospital Pharmacists, to 1984., p. 86:00

... /SODIUM ACETATE/ HAS BEEN USED FOR PARENTERAL THERAPY OF ACIDOTIC CONDITIONS. IT IS BOTH A SYSTEMIC & URINARY ALKALIZER. /SODIUM ACETATE TRIHYDRATE, USP/

Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 772

For more Therapeutic Uses (Complete) data for SODIUM ACETATE (8 total), please visit the HSDB record page.

4.3 Drug Indication

Injection, USP 40 mEq is indicated as a source of sodium, for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. Sodium acetate and other bicarbonate precursors are alkalinising agents, and can be used to correct metabolic acidosis, or for alkalinisation of the urine.

5 Pharmacology and Biochemistry

5.1 Pharmacology

Sodium is the principal cation of extracellular fluid. It comprises more than 90% of total cations at its normal plasma concentration of approximately 140 mEq/liter. The sodium ion exerts a primary role in controlling total body water and its distribution. Acetate ions acts as hydrogen ion acceptor which is alternative to bicarbonate.

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

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

5.3 ATC Code

B - Blood and blood forming organs

B05 - Blood substitutes and perfusion solutions

B05X - I.v. solution additives

B05XA - Electrolyte solutions

B05XA08 - Sodium acetate

5.4 Absorption, Distribution and Excretion

Absorption

It is readily available in the circulation after IV administration.

Route of Elimination

Both the sodium and bicarbonate ions are excreted mainly in the urine. Some sodium is excreted in the feces, and small amounts may also be excreted in saliva, sweat, bile and pancreatic secretions.

5.5 Metabolism/Metabolites

In liver, sodium acetate is being metabolized into bicarbonate. To form bicarbonate, acetate is slowly hydrolyzed to carbon dioxide and water, which are then converted to bicarbonate by the addition of a hydrogen ion.

THE ACETATE ION IS RAPIDLY & COMPLETELY METABOLIZED BY BODY, & CONSEQUENTLY ADMIN OF SODIUM ACETATE IS EVENTUALLY EQUIVALENT TO GIVING SODIUM BICARBONATE. /SODIUM ACETATE TRIHYDRATE, USP/

Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 772

CONSTANT RATE INFUSIONS OF SODIUM ACETATE GIVEN TO VOLUNTEERS, AT 4 MMOL/KG/HR INCR PLASMA ACETATE BY ONLY 0.41 MMOL/L, INDICATING A HIGH ACETATE METABOLIZING CAPACITY IN MAN.

KVEIM MH R ET AL; J OSLO CITY HOSP: 30 (8): 101 (1980)

Readily metabolized outside the liver.

American Medical Association. AMA Drug Evaluations Annual 1991. Chicago, IL: American Medical Association, 1991., p. 723

5.6 Mechanism of Action

It works as a source of sodium ions especially in cases of hyponatremic patients. Sodium has a primary role in regulating extracellular fluid volume. It controls water distribution, fluid and electrolyte balance and the osmotic pressure of body fluids. Sodium is also involved in nerve conduction, muscle contraction, acid-base balance and cell nutrient uptake.

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YORK","supplierAddress":"N\/A","customerAddress":"PLOT NO.B3,B4&B5 PT SIPCOT,INDUSTR"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734633000,"product":"SODIUM ACETATE ANHYDROUS EMPROVE EXPERT CHP,USP 17PCS X 12KG (PHARMA GRADE)ORGANIC CHEMICAL","address":"50A , RING ROAD,","city":"BANGALORE, KARNATAKA","supplier":"MERCK LIFE SCIENCE KGAA","supplierCountry":"CHINA","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"MERCK GROUP","customerCountry":"INDIA","quantity":"204.00","actualQuantity":"204","unit":"KGS","unitRateFc":"27.1","totalValueFC":"5585.3","currency":"USD","unitRateINR":"2326.4","date":"20-Dec-2024","totalValueINR":"474575.34","totalValueInUsd":"5585.3","indian_port":"Bombay Air","hs_no":"29152990","bill_no":"7364273","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"Frankfurter Strasse 250, 64293 Darm stadt,(BENEFICIARY MERCKFINANCIALS SERVICES GMBH) GERMANY","customerAddress":"50A , RING ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1735151400,"product":"SODIUM ACETATE USP (PHARMA GRADE FOR PHARMACEUTICALS USE ONLY)SODIUM ACETATE USP AGGLO20 KG BG","address":"306, STUDIO COMPLEX, NEAR GOTA CHAR","city":"AHMEDABAD -","supplier":"MACCO ORGANIQUES INC","supplierCountry":"CANADA","foreign_port":"MONTREAL-DORAVAL APT","customer":"TEKNIRVANA TRADELINK PRIVATE ","customerCountry":"INDIA","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"12.6","totalValueFC":"14907","currency":"USD","unitRateINR":"1266.6","date":"26-Dec-2024","totalValueINR":"1266632.84","totalValueInUsd":"14907","indian_port":"Bombay Air","hs_no":"29159099","bill_no":"7456240","productDescription":"API","marketType":"REGULATED MARKET","country":"CANADA","selfForZScoreResived":"Pharma Grade","supplierPort":"MONTREAL-DORAVAL APT","supplierAddress":"100,RUE MCAARTHUR,SOITE 112 VALLEYF IELD(QUEBEC) 365 4M5 Valleyfield, , Canada Canada","customerAddress":"306, STUDIO COMPLEX, NEAR GOTA CHAR"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1735583400,"product":"SODIUM ACETATE ANHYDROUS EMPROVE EXPERT CHP,USP 17PCS X 12KG (PHARMA GRADE)ORGANIC CHEMICAL","address":"50A , RING ROAD,","city":"BANGALORE, KARNATAKA","supplier":"MERCK LIFE SCIENCE KGAA","supplierCountry":"CHINA","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"MERCK GROUP","customerCountry":"INDIA","quantity":"204.00","actualQuantity":"204","unit":"KGS","unitRateFc":"27.1","totalValueFC":"5585.3","currency":"USD","unitRateINR":"2326.4","date":"31-Dec-2024","totalValueINR":"474575.34","totalValueInUsd":"5585.3","indian_port":"Bombay Air","hs_no":"29152990","bill_no":"7541788","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"Frankfurter Strasse 250, 64293 Darm stadt,(BENEFICIARY MERCKFINANCIALS SERVICES GMBH) GERMANY","customerAddress":"50A , RING ROAD,"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100...DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1440ML)