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Chemistry

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Also known as: 41100-52-1, Memantine hcl, Namenda, 3,5-dimethyl-1-adamantanamine hydrochloride, 3,5-dimethyladamantan-1-amine hydrochloride, Akatinol
Molecular Formula
C12H22ClN
Molecular Weight
215.76  g/mol
InChI Key
LDDHMLJTFXJGPI-UHFFFAOYSA-N
FDA UNII
JY0WD0UA60

Memantine Hydrochloride
AMANTADINE derivative that has some dopaminergic effects. It has been proposed as an antiparkinson agent.
1 2D Structure

Memantine Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
3,5-dimethyladamantan-1-amine;hydrochloride
2.1.2 InChI
InChI=1S/C12H21N.ClH/c1-10-3-9-4-11(2,6-10)8-12(13,5-9)7-10;/h9H,3-8,13H2,1-2H3;1H
2.1.3 InChI Key
LDDHMLJTFXJGPI-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC12CC3CC(C1)(CC(C3)(C2)N)C.Cl
2.2 Other Identifiers
2.2.1 UNII
JY0WD0UA60
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 1,3-dimethyl-5-aminoadamantane

2. 1-amino-3,5-dimethyladamantane

3. Axura

4. D 145

5. D-145

6. D145

7. Ebixa

8. Memantin

9. Memantine

10. Namenda

2.3.2 Depositor-Supplied Synonyms

1. 41100-52-1

2. Memantine Hcl

3. Namenda

4. 3,5-dimethyl-1-adamantanamine Hydrochloride

5. 3,5-dimethyladamantan-1-amine Hydrochloride

6. Akatinol

7. Axura

8. Namenda Xr

9. Memary

10. Ebixa

11. Memantine Mylan

12. 1-amino-3,5-dimethyladamantane Hydrochloride

13. Memantine Merz

14. Memantine.hcl

15. Memantine Accord

16. Memantine Lek

17. Memantine (hydrochloride)

18. Acrescent

19. Balaxur

20. Auxura

21. Unii-jy0wd0ua60

22. 3,5-dimethyladamantan-1-amine;hydrochloride

23. Jy0wd0ua60

24. Mfcd00214336

25. Memantine Ratiopharm

26. Memantine Hydrochloride [usan]

27. Chebi:64323

28. Sun-y7017

29. Nsc-102290

30. 3,5-dimethyladamantan-1-aminium Chloride

31. D-145

32. Mls001332605

33. 3,5-dimethyl-1-aminoadamantane Hydrochloride

34. (3,5-dimethyl-1-adamantyl)amine Hydrochloride

35. 3,5-dimethyltricyclo(3.3.1.1(3,7))decan-1-amine Hydrochloride

36. Fp-01

37. 1,3-dimethyl-5-adamantanamine Hcl

38. 3,5-dimethyltricyclo[3.3.1.13,7]decan-1-amine Hydrochloride

39. 41100-52-1 (hcl)

40. Tricyclo[3.3.1.13,7]decan-1-amine, 3,5-dimethyl-, Hydrochloride

41. D 145

42. Mantine

43. Ebixza

44. 3,5-dimethyl-tricyclo[3.3.1.13,7]decan-1-amine Hydrochloride

45. 3,5-dimethyltricyclo(3.3.1.13,7)decan-1-amine Hydrochloride

46. 3,5-dimethyltricyclo(3.3.1.1(sup 3,7))decan-1-amine Hydrochloride

47. Tricyclo(3.3.1.1(sup 3,7))decan-1-amine, 3,5-dimethyl-, Hydrochloride

48. 3,5-dimethyl-1-adamantylamine

49. 3,5-dimethyl-1-aminoadamantane

50. Smr000875213

51. Sr-01000075458

52. Sun Y7017

53. Einecs 255-219-6

54. Namenda (tn)

55. Memary (tn)

56. Marixino

57. Nsc 102290

58. D-145 (hydrochloride)

59. Schembl3053

60. C12h21n.hcl

61. Chembl1699

62. Mls001332606

63. Spectrum1501121

64. Hy-b0365a

65. Dtxsid90961439

66. Memantine Hydrochloride (namenda)

67. N06dx01

68. Nmi-131

69. Hms1571c17

70. Hms1921h03

71. Pharmakon1600-01501121

72. Memantine Hydrochloride (jan/usp)

73. Memantine Hydrochloride [mi]

74. Tox21_500861

75. Ac-559

76. Ccg-39018

77. Memantine Hydrochloride [jan]

78. Mrz-2/145

79. Nsc102290

80. Nsc757843

81. S2043

82. Akos015889460

83. Bcp9000253

84. Lp00861

85. Memantine Hydrochloride [mart.]

86. Nc00680

87. Memantine Hydrochloride [usp-rs]

88. Memantine Hydrochloride [who-dd]

89. Ncgc00094186-01

90. Ncgc00094186-02

91. Ncgc00094186-03

92. Ncgc00261546-01

93. As-13331

94. Bm164662

95. Memantine Hydrochloride [ema Epar]

96. Sy057917

97. 3,5-dimethyladamantan-1-aminehydrochloride

98. Am20070534

99. D3608

100. Eu-0100861

101. Ft-0650723

102. M-145

103. Memantine Hydrochloride [orange Book]

104. Sw060653-4

105. 1-amino-3,5-dimethyl-adamantane Hydrochloride

106. 3,5-dimethyladamantan-1-amine Hy-drochloride

107. 3,5-dimethyladamantan-1-amine;hydrochloride.

108. D04905

109. M 9292

110. Memantine Hydrochloride [usp Monograph]

111. Namzaric Component Memantine Hydrochloride

112. Memantine Hydrochloride Component Of Namzaric

113. Sr-01000075458-1

114. Sr-01000075458-3

115. Sr-01000075458-8

116. Q27133218

117. Z1551429722

118. Tricyclo(3.3.1.1(3,7))decan-1-amine, 3,5-dimethyl-, Hydrochloride

119. Tricyclo[3.3.1.13,7]decan-1-amine, 3,5-dimethyl-, Hydrochloride (1:1) (ca Index Name)

120. 1-amino-3,5-dimethyladamantane . Hcl 3,5-dimethyl-1-aminoadamantane . Hcl Memantine . Hydrochloride

2.4 Create Date
2005-07-19
3 Chemical and Physical Properties
Molecular Weight 215.76 g/mol
Molecular Formula C12H22ClN
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count1
Rotatable Bond Count0
Exact Mass215.1440774 g/mol
Monoisotopic Mass215.1440774 g/mol
Topological Polar Surface Area26 Ų
Heavy Atom Count14
Formal Charge0
Complexity240
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count2
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 6  
Drug NameMemantine hydrochloride
PubMed HealthMemantine (By mouth)
Drug ClassesCentral Nervous System Agent
Drug LabelNamenda (memantine hydrochloride) is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula: The molecular formula is C12H21N...
Active IngredientMemantine hydrochloride
Dosage FormTablet
Routeoral; Oral
Strength5mg; 10mg
Market StatusTentative Approval
CompanyAmneal Pharms; Alembic; Upsher Smith; Mylan Pharma; Unichem Pharms (usa); Apotex; Lupin Pharms; Aurobindo Pharma; Torrent Pharms; Macleods Pharms; Jubilant Life

2 of 6  
Drug NameNamenda
PubMed HealthMemantine (By mouth)
Drug ClassesCentral Nervous System Agent
Drug LabelNamenda (memantine hydrochloride) is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula: The molecular formula is C12H21N...
Active IngredientMemantine hydrochloride
Dosage FormTablet; Solution
RouteOral
Strength2mg/ml; 5mg; 10mg
Market StatusPrescription
CompanyForest Labs

3 of 6  
Drug NameNamenda xr
Drug LabelNAMENDA XR is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula: The molecular formula is C12H21NHCl and the molecular wei...
Active IngredientMemantine hydrochloride
Dosage FormCapsule, extended release
RouteOral
Strength7mg; 14mg; 21mg; 28mg
Market StatusPrescription
CompanyForest Labs

4 of 6  
Drug NameMemantine hydrochloride
PubMed HealthMemantine (By mouth)
Drug ClassesCentral Nervous System Agent
Drug LabelNamenda (memantine hydrochloride) is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula: The molecular formula is C12H21N...
Active IngredientMemantine hydrochloride
Dosage FormTablet
Routeoral; Oral
Strength5mg; 10mg
Market StatusTentative Approval
CompanyAmneal Pharms; Alembic; Upsher Smith; Mylan Pharma; Unichem Pharms (usa); Apotex; Lupin Pharms; Aurobindo Pharma; Torrent Pharms; Macleods Pharms; Jubilant Life

5 of 6  
Drug NameNamenda
PubMed HealthMemantine (By mouth)
Drug ClassesCentral Nervous System Agent
Drug LabelNamenda (memantine hydrochloride) is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula: The molecular formula is C12H21N...
Active IngredientMemantine hydrochloride
Dosage FormTablet; Solution
RouteOral
Strength2mg/ml; 5mg; 10mg
Market StatusPrescription
CompanyForest Labs

6 of 6  
Drug NameNamenda xr
Drug LabelNAMENDA XR is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula: The molecular formula is C12H21NHCl and the molecular wei...
Active IngredientMemantine hydrochloride
Dosage FormCapsule, extended release
RouteOral
Strength7mg; 14mg; 21mg; 28mg
Market StatusPrescription
CompanyForest Labs

4.2 Drug Indication

Treatment of patients with moderate to severe Alzheimer's disease.


Treatment of patients with moderate to severe Alzheimers disease.


Treatment of patients with moderate to severe Alzheimers disease.


Treatment of patients with moderate to severe Alzheimers disease.


Treatment of patients with moderate to severe Alzheimer's disease.


Treatment of patients with moderate to severe Alzheimers disease


Treatment of patients with moderate to severe Alzheimers disease.


Treatment of patients with moderate to severe Alzheimers disease.


Treatment of Alzheimers disease


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Antiparkinson Agents

Agents used in the treatment of Parkinson's disease. The most commonly used drugs act on the dopaminergic system in the striatum and basal ganglia or are centrally acting muscarinic antagonists. (See all compounds classified as Antiparkinson Agents.)


Dopamine Agents

Any drugs that are used for their effects on dopamine receptors, on the life cycle of dopamine, or on the survival of dopaminergic neurons. (See all compounds classified as Dopamine Agents.)


Excitatory Amino Acid Antagonists

Drugs that bind to but do not activate excitatory amino acid receptors, thereby blocking the actions of agonists. (See all compounds classified as Excitatory Amino Acid Antagonists.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
NMDA Receptor Antagonists [MoA]; N-methyl-D-aspartate Receptor Antagonist [EPC]
5.3 ATC Code

N06DX01


N06DX01


N06DX01


N06DX01


N06DX01


N06DX01


N06DX01


N06DX01


N06D


N06DA52


API Reference Price

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04-Jan-2022
30-May-2025
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DOSAGE - TABLET;ORAL - 10MG

USFDA APPLICATION NUMBER - 21487

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DOSAGE - TABLET;ORAL - 5MG

USFDA APPLICATION NUMBER - 21487

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 14M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 14MG

USFDA APPLICATION NUMBER - 22525

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 21M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 21MG

USFDA APPLICATION NUMBER - 22525

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 28M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 28MG

USFDA APPLICATION NUMBER - 22525

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 7MG...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22525

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ABOUT THIS PAGE

Looking for 41100-52-1 / Memantine Hydrochloride API manufacturers, exporters & distributors?

Memantine Hydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Memantine Hydrochloride

Synonyms

41100-52-1, Memantine hcl, Namenda, 3,5-dimethyl-1-adamantanamine hydrochloride, 3,5-dimethyladamantan-1-amine hydrochloride, Akatinol

Cas Number

41100-52-1

Unique Ingredient Identifier (UNII)

JY0WD0UA60

About Memantine Hydrochloride

AMANTADINE derivative that has some dopaminergic effects. It has been proposed as an antiparkinson agent.

Namenda Manufacturers

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

Namenda Suppliers

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

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

Namenda USDMF

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

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

click here to find a list of Namenda suppliers with USDMF on PharmaCompass.

Namenda 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 Namenda Drug Master File in Japan (Namenda JDMF) empowers Namenda 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 Namenda JDMF during the approval evaluation for pharmaceutical products. At the time of Namenda 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 Namenda suppliers with JDMF on PharmaCompass.

Namenda KDMF

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

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

After submitting a Namenda 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 Namenda API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Namenda suppliers with KDMF on PharmaCompass.

Namenda WC

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

click here to find a list of Namenda suppliers with Written Confirmation (WC) on PharmaCompass.

Namenda 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 Namenda as an active pharmaceutical ingredient (API).

Finished drug products

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

click here to find a list of Namenda suppliers with NDC on PharmaCompass.

Namenda GMP

Namenda 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 Namenda 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 Namenda GMP manufacturer or Namenda GMP API supplier for your needs.

Namenda CoA

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

Namenda CoA mostly includes findings from lab analyses of a specific batch. For each Namenda 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.

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