Phenylalanine Hydroxylase Activator [EPC] - N0000190483

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Pharmacologic Class Information

Pharmacologic Code N0000190483
Pharmacologic Name Phenylalanine Hydroxylase Activator
Pharmacologic Uses
  • phenylalanine hydroxylase activator
Pharmacologic Concept Established Pharmacologic Classes - [EPC]
Pharmacologic Concept Description An established pharmacologic class is a term or phrase that is scientifically valid and clinically meaningful according to the following definitions:
  • A scientifically valid pharmacologic class is supported by documented and submitted empiric evidence showing that the drug's pharmacologic class is known, not theoretical, and relevant and specific to the indication.
  • A clinically meaningful pharmacologic class term or phrase enhances the ability of professionals to understand physiologic effects related to the indication or to anticipate undesirable effects that may be associated with the drug or pharmacologic class.

NDC Products with Phenylalanine Hydroxylase Activator

The table contains 14 products whose active ingredient are classified under the same pharmacologic class Phenylalanine Hydroxylase Activator [EPC].

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Status
31722-045Sapropterin Dihydrochloride Non-Proprietary Name: Sapropterin DihydrochlorideTabletOralCamber Pharmaceuticals, Inc.ACTIVE
31722-047Sapropterin Dihydrochloride Non-Proprietary Name: Sapropterin DihydrochloridePowder, For SolutionOralCamber Pharmaceuticals, Inc.ACTIVE
31722-048Sapropterin Dihydrochloride Non-Proprietary Name: Sapropterin DihydrochloridePowder, For SolutionOralCamber Pharmaceuticals, Inc.ACTIVE
43598-096Javygtor Non-Proprietary Name: Sapropterin DihydrochlorideTabletOralDr. Reddys Laboratories IncACTIVE
43598-097Javygtor Non-Proprietary Name: Sapropterin DihydrochloridePowder, For SolutionOralDr. Reddys Laboratories IncACTIVE
43598-162Javygtor Non-Proprietary Name: Sapropterin DihydrochloridePowder, For SolutionOralDr. Reddys Laboratories IncACTIVE
43598-477Sapropterin Dihydrochloride Non-Proprietary Name: Sapropterin DihydrochloridePowder, For SolutionOralDr. Reddys Laboratories IncACTIVE
43598-749 Non-Proprietary Name: Sapropterin DihydrochlorideTabletDr. Reddy's Laboratories Inc.ACTIVE
43598-749Sapropterin Dihydrochloride Non-Proprietary Name: Sapropterin DihydrochlorideTabletOralDr. Reddys Laboratories Inc.ACTIVE
49884-720Sapropterin Dihydrochloride Non-Proprietary Name: Sapropterin DihydrochlorideTabletOralPar Pharmaceutical, Inc.ACTIVE
49884-873Sapropterin Dihydrochloride Non-Proprietary Name: Sapropterin DihydrochloridePowder, For SolutionOralPar Pharmaceutical, Inc.ACTIVE
49884-948Sapropterin Dihydrochloride Non-Proprietary Name: Sapropterin DihydrochloridePowder, For SolutionOralPar Pharmaceutical, Inc.ACTIVE
68135-300Kuvan Non-Proprietary Name: Sapropterin DihydrochlorideTabletOralBiomarin Pharmaceutical Inc.ACTIVE
68135-301Kuvan Non-Proprietary Name: Sapropterin DihydrochloridePowder, For SolutionOralBiomarin Pharmaceutical Inc.ACTIVE
68135-482Kuvan Non-Proprietary Name: Sapropterin DihydrochloridePowder, For SolutionOralBiomarin Pharmaceutical Inc.ACTIVE