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Chemistry

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Also known as: 73-78-9, Lidocaine hcl, Lidothesin, Xyloneural, Lignocaine hydrochloride, Lidocaine (hydrochloride)
Molecular Formula
C14H23ClN2O
Molecular Weight
270.80  g/mol
InChI Key
IYBQHJMYDGVZRY-UHFFFAOYSA-N
FDA UNII
EC2CNF7XFP

Lidocaine Hydrochloride
A local anesthetic and cardiac depressant used as an antiarrhythmia agent. Its actions are more intense and its effects more prolonged than those of PROCAINE but its duration of action is shorter than that of BUPIVACAINE or PRILOCAINE.
1 2D Structure

Lidocaine Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-(diethylamino)-N-(2,6-dimethylphenyl)acetamide;hydrochloride
2.1.2 InChI
InChI=1S/C14H22N2O.ClH/c1-5-16(6-2)10-13(17)15-14-11(3)8-7-9-12(14)4;/h7-9H,5-6,10H2,1-4H3,(H,15,17);1H
2.1.3 InChI Key
IYBQHJMYDGVZRY-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CCN(CC)CC(=O)NC1=C(C=CC=C1C)C.Cl
2.2 Other Identifiers
2.2.1 UNII
EC2CNF7XFP
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 2-(diethylamino)-n-(2,6-dimethylphenyl)acetamide

2. 2-2etn-2mephacn

3. Dalcaine

4. Lidocaine

5. Lidocaine Carbonate

6. Lidocaine Carbonate (2:1)

7. Lidocaine Hydrocarbonate

8. Lidocaine Monoacetate

9. Lidocaine Monohydrochloride

10. Lidocaine Monohydrochloride, Monohydrate

11. Lidocaine Sulfate (1:1)

12. Octocaine

13. Xylesthesin

14. Xylocaine

15. Xylocitin

16. Xyloneural

2.3.2 Depositor-Supplied Synonyms

1. 73-78-9

2. Lidocaine Hcl

3. Lidothesin

4. Xyloneural

5. Lignocaine Hydrochloride

6. Lidocaine (hydrochloride)

7. Lidocaton

8. Xylocard

9. Lidocaine Hydrochloride Anhydrous

10. Lidopen

11. Acetamide, 2-(diethylamino)-n-(2,6-dimethylphenyl)-, Monohydrochloride

12. Lta Ii Kit

13. Laryng-o-jet Kit

14. Ec2cnf7xfp

15. Linocaine Hydrochloride

16. Mls000069665

17. Laryngotracheal Anesthesia Kit

18. 2-(diethylamino)-n-(2,6-dimethylphenyl)acetamide Hydrochloride

19. 2-diethylamino-2',6'-acetoxylidide Hydrochloride

20. Alphacaine Hydrochloride

21. Nsc-757420

22. Smr000058468

23. Xylocaine (tn)

24. Alpha-diethylamino-2,6-acetoxylidine Hydrochloride

25. Laryng-o-jet

26. Omega-diethylamino-2,6-dimethylacetanilide Hydrochloride

27. Xilina Hydrochloride

28. 73-78-9 (hcl); 6108-05-0 (monohydrate)

29. Rucaina Hydrochloride

30. Xycaine Hydrochloride

31. Xylotox Hydrochloride

32. Duncaine Hydrochloride

33. Isicaine Hydrochloride

34. Lidocain Hydrochloride

35. Anestacon Hydrochloride

36. Gravocain Hydrochloride

37. Leostesin Hydrochloride

38. Xylocitin Hydrochloride

39. Lidothesin Hydrochloride

40. Xylestesin Hydrochloride

41. Glydo

42. Lidocaine Viscous

43. Pediatric Lta Kit

44. Chebi:50512

45. Xylocaine Preservative Free

46. Sr-01000000189

47. Unii-ec2cnf7xfp

48. Einecs 200-803-8

49. Xylocaine 4% Preservative Free

50. Xylocaine 5% W/ Glucose 7.5%

51. Lidocaine Hydrochloride Viscous

52. S 202

53. V 262

54. Xylocaine 1.5% W/ Dextrose 7.5%

55. Dalcaine (tn)

56. Prestwick_296

57. N-(diethylaminoacetyl)-2,6-dimethylaniline Hydrochloride

58. Lidoca Ne Hydrochloride

59. Lidocaine Hydrochloride Preservative Free

60. Opera_id_351

61. Lidocaine Hydrochloride In Plastic Container

62. Lidocaine Hydrochloride 0.2% In Dextrose 5%

63. Lidocaine Hydrochloride 0.4% In Dextrose 5%

64. Lidocaine Hydrochloride 5% And Dextrose 7.5%

65. Spectrum1500689

66. Chembl541521

67. Dtxsid4058782

68. Hy-b0185a

69. 2',6'-acetoxylidide, 2-(diethylamino)-, Monohydrochloride

70. Hms1568i21

71. Hms1921c22

72. Lidocaine Hydrochloride Preservative Free In Plastic Container

73. Pharmakon1600-01500689

74. Lidocaine Hydrochloride (jan/usp)

75. 2',6'-acetoxylidide, 2-(diethylamino)-, Hydrochloride

76. Bcp30473

77. Lidocaine Hydrochloride 0.2% In Dextrose 5% In Plastic Container

78. Lidocaine Hydrochloride 0.4% In Dextrose 5% In Plastic Container

79. Lidocaine Hydrochloride 0.8% In Dextrose 5% In Plastic Container

80. Tox21_500669

81. Ccg-39281

82. Lidocaine Hydrochloride [jan]

83. Lidocaine Hydrochloride 0.1% And Dextrose 5% In Plastic Container

84. Lidocaine Hydrochloride 0.2% And Dextrose 5% In Plastic Container

85. Lidocaine Hydrochloride 0.4% And Dextrose 5% In Plastic Container

86. Lidocaine Hydrochloride 0.8% And Dextrose 5% In Plastic Container

87. Nsc757420

88. S4667

89. (unlabeled)lidocaine-d6 Hydrochloride

90. Akos015889456

91. Cs-3888

92. Lp00669

93. Nsc 757420

94. Sb19119

95. Anhydrous Lidocaine Hydrochloride

96. Lidocaine Hydrochloride [who-dd]

97. Ncgc00094030-01

98. Ncgc00094030-02

99. Ncgc00094030-03

100. Ncgc00094030-04

101. Ncgc00094030-05

102. Ncgc00261354-01

103. Ac-11712

104. As-35171

105. Eu-0100669

106. Lignocaine Hydrochloride Pound>>lidocaine Hcl

107. A16132

108. D02086

109. L 5647

110. Lidocaine Hydrochloride Anhydrous [mart.]

111. A837924

112. Q-201304

113. Sr-01000000189-3

114. Sr-01000000189-9

115. Q27122094

116. 2-(diethylamino)-2',6'-acetoxylidide Monohydrochloride

117. 2-(diethylamino)-n-(2,6-dimethylphenyl)acetamide;hydrochloride

118. 2-(diethylamino)-n-(2,6-dimethylphenyl)ethanamide Hydrochloride

119. Acetamide, 2-(diethylamino)-n-(2,6-dimethylphenyl)-, Hydrochloride (1:1)

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 270.80 g/mol
Molecular Formula C14H23ClN2O
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count2
Rotatable Bond Count5
Exact Mass270.1498911 g/mol
Monoisotopic Mass270.1498911 g/mol
Topological Polar Surface Area32.3 Ų
Heavy Atom Count18
Formal Charge0
Complexity228
Isotope Atom Count0
Defined Atom Stereocenter Count0
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 18  
Drug NameLaryng-o-jet kit
Drug LabelDESCRIPTIONLidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% contains a local anesthetic agent and is administered topically. Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% contains lidocaine hydrochloride, which is che...
Active IngredientLidocaine hydrochloride
Dosage FormSolution
RouteTopical
Strength4%
Market StatusPrescription
CompanyIntl Medication

2 of 18  
Drug NameLidocaine hydrochloride
Active IngredientLidocaine hydrochloride
Dosage FormJelly; Injectable; Solution
RouteInjection; Oral; Topical
Strength0.5%; 1%; 20%; 2%; 4%
Market StatusPrescription
CompanyWockhardt; Igi Labs; Hospira; Roxane; Watson Labs; Intl Medication; Hi Tech Pharma; Vintage; Luitpold; Agila Speclts; Akorn

3 of 18  
Drug NameLidocaine hydrochloride in plastic container
Drug LabelEach mL contains:Lidocaine Hydrochloride . . . . . . . . . . 20 mg (2%)Inactive ingredients: flavoring, methylparaben, propylparaben, sodium carboxymethylcellulose, and sodium saccharin in an aqueous solution.Lidocaine Viscous (Lidocaine Hydrochlorid...
Active IngredientLidocaine hydrochloride
Dosage FormInjectable
RouteInjection
Strength0.5%; 1%; 2%
Market StatusPrescription
CompanyHospira; Fresenius Kabi Usa

4 of 18  
Drug NameLidocaine hydrochloride preservative free
Active IngredientLidocaine hydrochloride
Dosage FormInjectable
RouteInjection
Strength1%; 20%; 1.5%; 2%; 4%
Market StatusPrescription
CompanyHospira; Aurobindo Pharma; Intl Medication; Fresenius Kabi Usa; Agila Speclts

5 of 18  
Drug NameLidocaine hydrochloride preservative free in plastic container
Active IngredientLidocaine hydrochloride
Dosage FormInjectable
RouteInjection
Strength1%; 2%
Market StatusPrescription
CompanyHospira

6 of 18  
Drug NameLidocaine hydrochloride viscous
Active IngredientLidocaine hydrochloride
Dosage FormSolution
RouteOral
Strength2%
Market StatusPrescription
CompanyVintage

7 of 18  
Drug NameLidocaine viscous
Active IngredientLidocaine hydrochloride
Dosage FormSolution
RouteOral
Strength2%
Market StatusPrescription
CompanyRoxane

8 of 18  
Drug NameLta ii kit
Active IngredientLidocaine hydrochloride
Dosage FormSolution
RouteTopical
Strength4%
Market StatusPrescription
CompanyHospira

9 of 18  
Drug NameXylocaine preservative free
Active IngredientLidocaine hydrochloride
Dosage FormInjectable
RouteInjection
Strength1%; 20%; 2%; 4%
Market StatusPrescription
CompanyFresenius Kabi Usa

10 of 18  
Drug NameLaryng-o-jet kit
Drug LabelDESCRIPTIONLidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% contains a local anesthetic agent and is administered topically. Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% contains lidocaine hydrochloride, which is che...
Active IngredientLidocaine hydrochloride
Dosage FormSolution
RouteTopical
Strength4%
Market StatusPrescription
CompanyIntl Medication

11 of 18  
Drug NameLidocaine hydrochloride
Active IngredientLidocaine hydrochloride
Dosage FormJelly; Injectable; Solution
RouteInjection; Oral; Topical
Strength0.5%; 1%; 20%; 2%; 4%
Market StatusPrescription
CompanyWockhardt; Igi Labs; Hospira; Roxane; Watson Labs; Intl Medication; Hi Tech Pharma; Vintage; Luitpold; Agila Speclts; Akorn

12 of 18  
Drug NameLidocaine hydrochloride in plastic container
Drug LabelEach mL contains:Lidocaine Hydrochloride . . . . . . . . . . 20 mg (2%)Inactive ingredients: flavoring, methylparaben, propylparaben, sodium carboxymethylcellulose, and sodium saccharin in an aqueous solution.Lidocaine Viscous (Lidocaine Hydrochlorid...
Active IngredientLidocaine hydrochloride
Dosage FormInjectable
RouteInjection
Strength0.5%; 1%; 2%
Market StatusPrescription
CompanyHospira; Fresenius Kabi Usa

13 of 18  
Drug NameLidocaine hydrochloride preservative free
Active IngredientLidocaine hydrochloride
Dosage FormInjectable
RouteInjection
Strength1%; 20%; 1.5%; 2%; 4%
Market StatusPrescription
CompanyHospira; Aurobindo Pharma; Intl Medication; Fresenius Kabi Usa; Agila Speclts

14 of 18  
Drug NameLidocaine hydrochloride preservative free in plastic container
Active IngredientLidocaine hydrochloride
Dosage FormInjectable
RouteInjection
Strength1%; 2%
Market StatusPrescription
CompanyHospira

15 of 18  
Drug NameLidocaine hydrochloride viscous
Active IngredientLidocaine hydrochloride
Dosage FormSolution
RouteOral
Strength2%
Market StatusPrescription
CompanyVintage

16 of 18  
Drug NameLidocaine viscous
Active IngredientLidocaine hydrochloride
Dosage FormSolution
RouteOral
Strength2%
Market StatusPrescription
CompanyRoxane

17 of 18  
Drug NameLta ii kit
Active IngredientLidocaine hydrochloride
Dosage FormSolution
RouteTopical
Strength4%
Market StatusPrescription
CompanyHospira

18 of 18  
Drug NameXylocaine preservative free
Active IngredientLidocaine hydrochloride
Dosage FormInjectable
RouteInjection
Strength1%; 20%; 2%; 4%
Market StatusPrescription
CompanyFresenius Kabi Usa

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Voltage-Gated Sodium Channel Blockers

A class of drugs that inhibit the activation of VOLTAGE-GATED SODIUM CHANNELS. (See all compounds classified as Voltage-Gated Sodium Channel Blockers.)


Anesthetics, Local

Drugs that block nerve conduction when applied locally to nerve tissue in appropriate concentrations. They act on any part of the nervous system and on every type of nerve fiber. In contact with a nerve trunk, these anesthetics can cause both sensory and motor paralysis in the innervated area. Their action is completely reversible. (From Gilman AG, et. al., Goodman and Gilman's The Pharmacological Basis of Therapeutics, 8th ed) Nearly all local anesthetics act by reducing the tendency of voltage-dependent sodium channels to activate. (See all compounds classified as Anesthetics, Local.)


Anti-Arrhythmia Agents

Agents used for the treatment or prevention of cardiac arrhythmias. They may affect the polarization-repolarization phase of the action potential, its excitability or refractoriness, or impulse conduction or membrane responsiveness within cardiac fibers. Anti-arrhythmia agents are often classed into four main groups according to their mechanism of action: sodium channel blockade, beta-adrenergic blockade, repolarization prolongation, or calcium channel blockade. (See all compounds classified as Anti-Arrhythmia Agents.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Amides [CS]; Antiarrhythmic [EPC]; Local Anesthesia [PE]; Amide Local Anesthetic [EPC]

API SUPPLIERS

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GDUFA

DMF Review : Complete

Rev. Date : 2014-06-05

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Submission : 1985-06-10

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CEP/COS

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CEP 1996-020 - Rev 09
Valid
Chemical
2024-05-29
227
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Certificate Number : CEP 1996-020 - Rev 09

Status : Valid

Issue Date : 2024-05-29

Type : Chemical

Substance Number : 227

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Certificate Number : R0-CEP 2011-210 - Rev 00

Status : Withdrawn by Holder

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Type : Chemical

Substance Number : 227

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LIDOCAINE HYDROCHLORIDE

Registration Number : 219MF10205

Registrant's Address : Cesar Martinell i Brunet 12A, Poligono Rubi Sur, Rubi (Barcelona), Spain

Initial Date of Registration : 2007-06-13

Latest Date of Registration : 2021-04-02

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Lidocaine hydrochloride

Registration Number : 218MF10963

Registrant's Address : SE-691 85 Karlskoga, SWEDEN

Initial Date of Registration : 2006-12-01

Latest Date of Registration : 2006-12-01

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Lidocaine hydrochloride

Registration Number : 217MF10050

Registrant's Address : 4-8-2 Nihonbashi Honcho, Chuo-ku, Tokyo

Initial Date of Registration : 2005-05-20

Latest Date of Registration : 2009-01-28

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API Reference Price

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10-Jan-2022
29-Apr-2025
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - INJECTABLE;INJECTION - 4%

USFDA APPLICATION NUMBER - 10417

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DOSAGE - INJECTABLE;INJECTION - 1% **Federal ...DOSAGE - INJECTABLE;INJECTION - 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 16801

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DOSAGE - INJECTABLE;INJECTION - 2% **Federal ...DOSAGE - INJECTABLE;INJECTION - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 16801

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DOSAGE - INJECTABLE;INJECTION - 20% **Federal...DOSAGE - INJECTABLE;INJECTION - 20% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 16801

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DOSAGE - INJECTABLE;INJECTION - 4% **Federal ...DOSAGE - INJECTABLE;INJECTION - 4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 16801

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DOSAGE - INJECTABLE;INJECTION - 0.005MG/ML;0....DOSAGE - INJECTABLE;INJECTION - 0.005MG/ML;0.5%

USFDA APPLICATION NUMBER - 6488

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DOSAGE - INJECTABLE;INJECTION - 0.005MG/ML;1%

USFDA APPLICATION NUMBER - 6488

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DOSAGE - INJECTABLE;INJECTION - 0.005MG/ML;1....DOSAGE - INJECTABLE;INJECTION - 0.005MG/ML;1.5%

USFDA APPLICATION NUMBER - 6488

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DOSAGE - INJECTABLE;INJECTION - 0.005MG/ML;2%

USFDA APPLICATION NUMBER - 6488

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DOSAGE - INJECTABLE;INJECTION - 0.01MG/ML;1%

USFDA APPLICATION NUMBER - 6488

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DOSAGE - INJECTABLE;INJECTION - 0.01MG/ML;2%

USFDA APPLICATION NUMBER - 6488

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DOSAGE - INJECTABLE;INJECTION - 0.02MG/ML;2%

USFDA APPLICATION NUMBER - 6488

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DOSAGE - INJECTABLE;INJECTION - 0.5%

USFDA APPLICATION NUMBER - 6488

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DOSAGE - INJECTABLE;INJECTION - 1%

USFDA APPLICATION NUMBER - 6488

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DOSAGE - INJECTABLE;INJECTION - 1.5%

USFDA APPLICATION NUMBER - 6488

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DOSAGE - INJECTABLE;INJECTION - 2%

USFDA APPLICATION NUMBER - 6488

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DOSAGE - INJECTABLE;INJECTION - 1%

USFDA APPLICATION NUMBER - 83158

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DOSAGE - INJECTABLE;INJECTION - 2%

USFDA APPLICATION NUMBER - 83158

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DOSAGE - INJECTABLE;INJECTION - 1%

USFDA APPLICATION NUMBER - 83173

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DOSAGE - INJECTABLE;SPINAL - 5%

USFDA APPLICATION NUMBER - 83914

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DOSAGE - JELLY;TOPICAL - 2% **Federal Registe...DOSAGE - JELLY;TOPICAL - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 8816

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DOSAGE - INJECTABLE;INJECTION - EQ 0.02MG BAS...DOSAGE - INJECTABLE;INJECTION - EQ 0.02MG BASE/ML;2%

USFDA APPLICATION NUMBER - 88389

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DOSAGE - INJECTABLE;INJECTION - EQ 0.01MG BAS...DOSAGE - INJECTABLE;INJECTION - EQ 0.01MG BASE/ML;2%

USFDA APPLICATION NUMBER - 88390

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Looking for 73-78-9 / Lidocaine Hydrochloride API manufacturers, exporters & distributors?

Lidocaine Hydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Lidocaine Hydrochloride

Synonyms

73-78-9, Lidocaine hcl, Lidothesin, Xyloneural, Lignocaine hydrochloride, Lidocaine (hydrochloride)

Cas Number

73-78-9

Unique Ingredient Identifier (UNII)

EC2CNF7XFP

About Lidocaine Hydrochloride

A local anesthetic and cardiac depressant used as an antiarrhythmia agent. Its actions are more intense and its effects more prolonged than those of PROCAINE but its duration of action is shorter than that of BUPIVACAINE or PRILOCAINE.

LIDOCAINE HCL PRESERVATIVE FREE Manufacturers

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

LIDOCAINE HCL PRESERVATIVE FREE Suppliers

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

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

LIDOCAINE HCL PRESERVATIVE FREE USDMF

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

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

click here to find a list of LIDOCAINE HCL PRESERVATIVE FREE suppliers with USDMF on PharmaCompass.

LIDOCAINE HCL PRESERVATIVE FREE JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The LIDOCAINE HCL PRESERVATIVE FREE Drug Master File in Japan (LIDOCAINE HCL PRESERVATIVE FREE JDMF) empowers LIDOCAINE HCL PRESERVATIVE FREE API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the LIDOCAINE HCL PRESERVATIVE FREE JDMF during the approval evaluation for pharmaceutical products. At the time of LIDOCAINE HCL PRESERVATIVE FREE JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of LIDOCAINE HCL PRESERVATIVE FREE suppliers with JDMF on PharmaCompass.

LIDOCAINE HCL PRESERVATIVE FREE KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a LIDOCAINE HCL PRESERVATIVE FREE Drug Master File in Korea (LIDOCAINE HCL PRESERVATIVE FREE KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of LIDOCAINE HCL PRESERVATIVE FREE. The MFDS reviews the LIDOCAINE HCL PRESERVATIVE FREE KDMF as part of the drug registration process and uses the information provided in the LIDOCAINE HCL PRESERVATIVE FREE KDMF to evaluate the safety and efficacy of the drug.

After submitting a LIDOCAINE HCL PRESERVATIVE FREE KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their LIDOCAINE HCL PRESERVATIVE FREE API can apply through the Korea Drug Master File (KDMF).

click here to find a list of LIDOCAINE HCL PRESERVATIVE FREE suppliers with KDMF on PharmaCompass.

LIDOCAINE HCL PRESERVATIVE FREE CEP

A LIDOCAINE HCL PRESERVATIVE FREE CEP of the European Pharmacopoeia monograph is often referred to as a LIDOCAINE HCL PRESERVATIVE FREE Certificate of Suitability (COS). The purpose of a LIDOCAINE HCL PRESERVATIVE FREE CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of LIDOCAINE HCL PRESERVATIVE FREE EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of LIDOCAINE HCL PRESERVATIVE FREE to their clients by showing that a LIDOCAINE HCL PRESERVATIVE FREE CEP has been issued for it. The manufacturer submits a LIDOCAINE HCL PRESERVATIVE FREE CEP (COS) as part of the market authorization procedure, and it takes on the role of a LIDOCAINE HCL PRESERVATIVE FREE CEP holder for the record. Additionally, the data presented in the LIDOCAINE HCL PRESERVATIVE FREE CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the LIDOCAINE HCL PRESERVATIVE FREE DMF.

A LIDOCAINE HCL PRESERVATIVE FREE CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. LIDOCAINE HCL PRESERVATIVE FREE CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of LIDOCAINE HCL PRESERVATIVE FREE suppliers with CEP (COS) on PharmaCompass.

LIDOCAINE HCL PRESERVATIVE FREE WC

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

click here to find a list of LIDOCAINE HCL PRESERVATIVE FREE suppliers with Written Confirmation (WC) on PharmaCompass.

LIDOCAINE HCL PRESERVATIVE FREE 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 LIDOCAINE HCL PRESERVATIVE FREE as an active pharmaceutical ingredient (API).

Finished drug products

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

click here to find a list of LIDOCAINE HCL PRESERVATIVE FREE suppliers with NDC on PharmaCompass.

LIDOCAINE HCL PRESERVATIVE FREE GMP

LIDOCAINE HCL PRESERVATIVE FREE 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 LIDOCAINE HCL PRESERVATIVE FREE 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 LIDOCAINE HCL PRESERVATIVE FREE GMP manufacturer or LIDOCAINE HCL PRESERVATIVE FREE GMP API supplier for your needs.

LIDOCAINE HCL PRESERVATIVE FREE CoA

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

LIDOCAINE HCL PRESERVATIVE FREE CoA mostly includes findings from lab analyses of a specific batch. For each LIDOCAINE HCL PRESERVATIVE FREE 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.

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