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Chemistry

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Also known as: Dexmethylphenidate hcl, Focalin, D-threo-methylphenidate hydrochloride, 19262-68-1, Focalin xr, 23655-65-4
Molecular Formula
C14H20ClNO2
Molecular Weight
269.77  g/mol
InChI Key
JUMYIBMBTDDLNG-OJERSXHUSA-N
FDA UNII
1678OK0E08

Dexmethylphenidate
A methylphenidate derivative, DOPAMINE UPTAKE INHIBITOR and CENTRAL NERVOUS SYSTEM STIMULANT that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.
1 2D Structure

Dexmethylphenidate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
methyl (2R)-2-phenyl-2-[(2R)-piperidin-2-yl]acetate;hydrochloride
2.1.2 InChI
InChI=1S/C14H19NO2.ClH/c1-17-14(16)13(11-7-3-2-4-8-11)12-9-5-6-10-15-12;/h2-4,7-8,12-13,15H,5-6,9-10H2,1H3;1H/t12-,13-;/m1./s1
2.1.3 InChI Key
JUMYIBMBTDDLNG-OJERSXHUSA-N
2.1.4 Canonical SMILES
COC(=O)C(C1CCCCN1)C2=CC=CC=C2.Cl
2.1.5 Isomeric SMILES
COC(=O)[C@@H]([C@H]1CCCCN1)C2=CC=CC=C2.Cl
2.2 Other Identifiers
2.2.1 UNII
1678OK0E08
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Dexmethylphenidate

2. Focalin

3. Focalin Xr

4. Hydrochloride, Dexmethylphenidate

5. Xr, Focalin

2.3.2 Depositor-Supplied Synonyms

1. Dexmethylphenidate Hcl

2. Focalin

3. D-threo-methylphenidate Hydrochloride

4. 19262-68-1

5. Focalin Xr

6. 23655-65-4

7. Metadate Cd

8. Metadate Er

9. Equasym Xl

10. Dexmethylphenidate Hydrochloride [usan]

11. Ritalin

12. 4b3sc438hi

13. Dex-methylphenidate Hydrochloride

14. Methyl (2r)-2-phenyl-2-[(2r)-piperidin-2-yl]acetate;hydrochloride

15. 1678ok0e08

16. Methylphenidate D-threo-form Hydrochloride

17. Methyl (2r)-phenyl((2r)-piperidin-2-yl)acetate Hydrochloride

18. 19262-68-1 (hcl)

19. Methyl (2r)-2-phenyl-2-[(2r)-piperidin-1-ium-2-yl]acetate;chloride

20. Quillichew

21. Quillivant

22. Aptensio

23. Foquest

24. Oros Mph

25. Aptensio Xr

26. Methylin Er

27. Ritalin La

28. Ritalin Sr

29. Chembl904

30. (r)-methyl 2-phenyl-2-((r)-piperidin-2-yl)acetate Hydrochloride

31. Daytrana

32. Dexmethylphenidate Hydrochloride (usan)

33. Spd544

34. Spd-544

35. Dl-threo-methylphenidate Hcl

36. Biphentin

37. Equasym

38. Methypatch

39. Metadate Mr

40. Unii-1678ok0e08

41. Equasym Ir

42. Ritalin Qd

43. Focalin (tn)

44. Dl-threo-methylphenidate Hydrochloride

45. Adhansia Xr

46. Jornay Pm

47. Methyl .alpha.-phenyl-2-piperidineacetate Hydrochloride

48. Unii-4b3sc438hi

49. Nwp-06

50. Dtxsid50940927

51. D-threo Methylphenidate Hydrochloride

52. Akos027321667

53. Rac-threo-methylphenidate Hydrochloride

54. 2-piperidineacetic Acid, Alpha-phenyl-, Methyl Ester, Hydrochloride, (alphar,2r)-

55. 2-piperidineacetic Acid, Alpha-phenyl-, Methyl Ester, Hydrochloride, (r*,r*)- (+-)-

56. 2-piperidineacetic Acid, Alpha-phenyl-, Methyl Ester, Hydrochloride, (r-(r*,r*))-

57. Methylphenidate Hydrochloride [mi]

58. (+/-)-threo-methylphenidate Hydrochloride

59. Methylphenidate Hydrochloride [jan]

60. Methylphenidate Hydrochloride [mart.]

61. Methylphenidate Hydrochloride [vandf]

62. Methylphenidate Hydrochloride [who-dd]

63. D03721

64. Dexmethylphenidate Hydrochloride [mart.]

65. Dexmethylphenidate Hydrochloride [vandf]

66. Dexmethylphenidate Hydrochloride [who-dd]

67. Methylphenidate Hydrochloride [orange Book]

68. Methylphenidate Hydrochloride Cii [usp-rs]

69. Methylphenidate Hydrochloride [ep Monograph]

70. Methylphenidate Hydrochloride [usp Monograph]

71. Dexmethylphenidate Hydrochloride [orange Book]

72. Methylphenidate D-threo-form Hydrochloride [mi]

73. Q47487562

74. Azstarys Component Dexmethylphenidate Hydrochloride

75. Dexmethylphenidate Hydrochloride Component Of Azstarys

76. Methyl Phenyl(piperidin-2-yl)acetate--hydrogen Chloride (1/1)

77. Methylphenidate Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

78. 2-piperidineacetic Acid, .alpha.-phenyl-, Methyl Ester, Hydrochloride, (r*,r*)-(+/-)-

79. 2-piperidineacetic Acid, .alpha.-phenyl-, Methyl Ester, Hydrochloride,(.alpha.r,2r)-

2.4 Create Date
2005-08-08
3 Chemical and Physical Properties
Molecular Weight 269.77 g/mol
Molecular Formula C14H20ClNO2
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count3
Rotatable Bond Count4
Exact Mass269.1182566 g/mol
Monoisotopic Mass269.1182566 g/mol
Topological Polar Surface Area38.3 Ų
Heavy Atom Count18
Formal Charge0
Complexity249
Isotope Atom Count0
Defined Atom Stereocenter Count2
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 6  
Drug NameDexmethylphenidate hydrochloride
Drug LabelFocalin (dexmethylphenidate hydrochloride) is the d-threo-enantiomer of racemic methylphenidate hydrochloride, which is a 50/50 mixture of the d-threo and l-threo-enantiomers. Focalin is a central nervous system (CNS) stimulant, available in 3 tabl...
Active IngredientDexmethylphenidate hydrochloride
Dosage FormTablet; Capsule, extended release
Routeoral; Oral
Strength2.5mg; 5mg; 25mg; 30mg; 10mg; 15mg; 40mg; 20mg
Market StatusTentative Approval; Prescription
CompanyWatson Labs; Mylan Pharms; Teva Pharms; Intellipharmaceutics; Teva Pharms Usa

2 of 6  
Drug NameFocalin
PubMed HealthDexmethylphenidate (By mouth)
Drug ClassesCNS Stimulant
Drug LabelFocalin (dexmethylphenidate hydrochloride) is the d-threo-enantiomer of racemic methylphenidate hydrochloride, which is a 50/50 mixture of the d-threo and l-threo-enantiomers. Focalin is a central nervous system (CNS) stimulant, available in 3 tabl...
Active IngredientDexmethylphenidate hydrochloride
Dosage FormTablet
RouteOral
Strength2.5mg; 5mg; 10mg
Market StatusPrescription
CompanyNovartis

3 of 6  
Drug NameFocalin xr
PubMed HealthDexmethylphenidate (By mouth)
Drug ClassesCNS Stimulant
Drug LabelFocalin XR is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Focalin XR uses the proprietary SODAS (Spheroidal Oral Drug Absorption System) technology. Each bead-filled Focalin XR capsule contains half the dose...
Active IngredientDexmethylphenidate hydrochloride
Dosage FormCapsule, extended release
RouteOral
Strength25mg; 30mg; 15mg; 5mg; 10mg; 40mg; 20mg; 35mg
Market StatusPrescription
CompanyNovartis

4 of 6  
Drug NameDexmethylphenidate hydrochloride
Drug LabelFocalin (dexmethylphenidate hydrochloride) is the d-threo-enantiomer of racemic methylphenidate hydrochloride, which is a 50/50 mixture of the d-threo and l-threo-enantiomers. Focalin is a central nervous system (CNS) stimulant, available in 3 tabl...
Active IngredientDexmethylphenidate hydrochloride
Dosage FormTablet; Capsule, extended release
Routeoral; Oral
Strength2.5mg; 5mg; 25mg; 30mg; 10mg; 15mg; 40mg; 20mg
Market StatusTentative Approval; Prescription
CompanyWatson Labs; Mylan Pharms; Teva Pharms; Intellipharmaceutics; Teva Pharms Usa

5 of 6  
Drug NameFocalin
PubMed HealthDexmethylphenidate (By mouth)
Drug ClassesCNS Stimulant
Drug LabelFocalin (dexmethylphenidate hydrochloride) is the d-threo-enantiomer of racemic methylphenidate hydrochloride, which is a 50/50 mixture of the d-threo and l-threo-enantiomers. Focalin is a central nervous system (CNS) stimulant, available in 3 tabl...
Active IngredientDexmethylphenidate hydrochloride
Dosage FormTablet
RouteOral
Strength2.5mg; 5mg; 10mg
Market StatusPrescription
CompanyNovartis

6 of 6  
Drug NameFocalin xr
PubMed HealthDexmethylphenidate (By mouth)
Drug ClassesCNS Stimulant
Drug LabelFocalin XR is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Focalin XR uses the proprietary SODAS (Spheroidal Oral Drug Absorption System) technology. Each bead-filled Focalin XR capsule contains half the dose...
Active IngredientDexmethylphenidate hydrochloride
Dosage FormCapsule, extended release
RouteOral
Strength25mg; 30mg; 15mg; 5mg; 10mg; 40mg; 20mg; 35mg
Market StatusPrescription
CompanyNovartis

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Dopamine Uptake Inhibitors

Drugs that block the transport of DOPAMINE into axon terminals or into storage vesicles within terminals. Most of the ADRENERGIC UPTAKE INHIBITORS also inhibit dopamine uptake. (See all compounds classified as Dopamine Uptake Inhibitors.)


Central Nervous System Stimulants

A loosely defined group of drugs that tend to increase behavioral alertness, agitation, or excitation. They work by a variety of mechanisms, but usually not by direct excitation of neurons. The many drugs that have such actions as side effects to their main therapeutic use are not included here. (See all compounds classified as Central Nervous System Stimulants.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Central Nervous System Stimulation [PE]; Central Nervous System Stimulant [EPC]

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Veranova

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Cohance Lifesciences

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Noramco

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Chattem Chemicals, Inc

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Mallinckrodt Pharmaceuticals

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Alkem Laboratories

India

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Curia

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American Pacific Corporation

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Siegfried AG

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Dishman Carbogen Amcis

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Veranova Lp

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DMF Review : N/A

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DMF Number : 15059

Submission : 2000-09-22

Status : Active

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MAGHREB PHARMA
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DMF Review : Complete

Rev. Date : 2018-09-10

Pay. Date : 2018-06-28

DMF Number : 32902

Submission : 2018-06-23

Status : Active

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Pay. Date : 2017-10-10

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Chattem Chemicals Inc

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Submission : 2009-09-23

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Curia Missouri Inc

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Rev. Date : 2013-06-24

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Lonza Inc

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Specgx Llc

Ireland

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Specgx Llc

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Pay. Date : 2018-04-06

DMF Number : 30657

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Siegfried Usa Llc

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Siegfried Usa Llc

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Veranova

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Noramco

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Curia

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Curia

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Dexmethylphenidate Hydrochloride

About the Company : Harman Finochem Limited is a leading India-based Pharmaceutical Company which specializes in the manufacture and export of more than 45 Active Pharmaceutical Ingredients (APls) of ...

Harman Finochem Limited is a leading India-based Pharmaceutical Company which specializes in the manufacture and export of more than 45 Active Pharmaceutical Ingredients (APls) of which 10 are Essential Drugs as per the WHO Model List. We deliver top quality products to more than 35 countries across the globe. Harman Finochem ensures that its customers worldwide are delighted by receiving APl’s which are safe, efficient and of highest quality. We adhere to principles of cGmp and our team at all levels is committed to achieving this corporate excellence goal.
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Cophex
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CAS Number : 741705-70-4

End Use API : Dexmethylphenidate

About The Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commer...

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SCI PHARMTECH

Taiwan
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CAS Number : 741705-70-4

End Use API : Dexmethylphenidate

About The Company : SCI Pharmtech Inc. offers APIs, advanced intermediates, and custom products, focusing on quick development and cost-effective production. Our research labs, pil...

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DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 5MG

Packaging :

Approval Date : 2020-09-09

Application Number : 213813

Regulatory Info : RX

Registration Country : USA

Granules India

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DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2020-09-09

Application Number : 213813

Regulatory Info : RX

Registration Country : USA

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DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 15MG

Packaging :

Approval Date : 2020-09-09

Application Number : 213813

Regulatory Info : RX

Registration Country : USA

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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 20MG

Packaging :

Approval Date : 2020-09-09

Application Number : 213813

Regulatory Info : RX

Registration Country : USA

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DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 25MG

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Approval Date : 2020-09-09

Application Number : 213813

Regulatory Info : RX

Registration Country : USA

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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 30MG

Packaging :

Approval Date : 2020-09-09

Application Number : 213813

Regulatory Info : RX

Registration Country : USA

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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE

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Dosage Strength : 35MG

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Approval Date : 2020-09-09

Application Number : 213813

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DEXMETHYLPHENIDATE HYDROCHLORIDE

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Dosage Strength : 40MG

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Approval Date : 2020-09-09

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Sandoz B2B

Switzerland
MAGHREB PHARMA
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Sandoz B2B

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DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : FOCALIN XR

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 40MG

Packaging :

Approval Date : 2010-08-11

Application Number : 21802

Regulatory Info : RX

Registration Country : USA

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DEXMETHYLPHENIDATE HYDROCHLORIDE

Brand Name : DEXMETHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 5MG

Packaging :

Approval Date : 2016-11-30

Application Number : 202842

Regulatory Info : RX

Registration Country : USA

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Europe

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Dexmethylphenidati hydrochloridum

Brand Name : Focalin XR

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Dexmethylphenidati hydrochloridum

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Dexmethylphenidati hydrochloridum

Brand Name : Focalin XR

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Registration Country : Switzerland

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Dexmethylphenidati hydrochloridum

Brand Name : Focalin XR

Dosage Form : Ret Kaps

Dosage Strength : 15mg

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Application Number :

Regulatory Info :

Registration Country : Switzerland

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Dexmethylphenidati hydrochloridum

Brand Name : Focalin XR

Dosage Form : Ret Caps

Dosage Strength : 20mg

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Approval Date :

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Registration Country : Switzerland

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Dexmethylphenidati hydrochloridum

Brand Name : Focalin XR

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Approval Date :

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Registration Country : Switzerland

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Dexmethylphenidati hydrochloridum

Brand Name : Focalin XR

Dosage Form : Ret Kaps

Dosage Strength : 5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Dexmethylphenidati hydrochloridum

Brand Name : Focalin XR

Dosage Form : Ret Kaps

Dosage Strength : 5mg

Packaging :

Approval Date :

Application Number :

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Registration Country : Switzerland

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 10MG

USFDA APPLICATION NUMBER - 21278

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DOSAGE - TABLET;ORAL - 2.5MG

USFDA APPLICATION NUMBER - 21278

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DOSAGE - TABLET;ORAL - 5MG

USFDA APPLICATION NUMBER - 21278

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10MG

USFDA APPLICATION NUMBER - 21802

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 15M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 15MG

USFDA APPLICATION NUMBER - 21802

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 20M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 20MG

USFDA APPLICATION NUMBER - 21802

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 25M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 25MG

USFDA APPLICATION NUMBER - 21802

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 30M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 30MG

USFDA APPLICATION NUMBER - 21802

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 35M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 35MG

USFDA APPLICATION NUMBER - 21802

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 40M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 40MG

USFDA APPLICATION NUMBER - 21802

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 5MG

USFDA APPLICATION NUMBER - 21802

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ABOUT THIS PAGE

Looking for 19262-68-1 / Dexmethylphenidate API manufacturers, exporters & distributors?

Dexmethylphenidate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Dexmethylphenidate

Synonyms

Dexmethylphenidate hcl, Focalin, D-threo-methylphenidate hydrochloride, 19262-68-1, Focalin xr, 23655-65-4

Cas Number

19262-68-1

Unique Ingredient Identifier (UNII)

1678OK0E08

About Dexmethylphenidate

A methylphenidate derivative, DOPAMINE UPTAKE INHIBITOR and CENTRAL NERVOUS SYSTEM STIMULANT that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.

Focalin Manufacturers

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

Focalin Suppliers

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

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

Focalin USDMF

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

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

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

Focalin 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 Focalin as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Focalin GMP

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

Focalin CoA

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

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

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