68135-300 : Kuvan 100 mg Oral Tablet for 4-8 Oz Oral Solution

Labeler: Biomarin Pharmaceutical Inc.
Product Type: Human Prescription Drug
Drug Name:  Kuvan
Dosage Form: Oral Tablet
Application #: NDA022181
Rev. Date: 


Markings: 177
Shapes:  Round
Colors:  White
Size (mm): 10
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 68135-300-02: 120 TABLET IN 1 BOTTLE (68135‑300‑02)

Active Ingredients:

  • Sapropterin Dihydrochloride

Dosage Strength:

  • 100 mg

Inactive Ingredients:

  • Ascorbic Acid
  • Crospovidone
  • Calcium Phosphate, Dibasic, Anhydrous
  • Mannitol
  • Riboflavin
  • Sodium Stearyl Fumarate

Pharmaceutical Classes:

  • Phenylalanine Hydroxylase Activator [EPC]
  • Phenylalanine Hydroxylase Activators [MoA]
  • Breast Cancer Resistance Protein Inhibitors [MoA]
  • P-Glycoprotein Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 68135-301 Kuvan 100 mg/1 Oral Powder, for Solution by Biomarin Pharmaceutical Inc.
  • 68135-482 Kuvan 500 mg Oral Powder, for Solution by Biomarin Pharmaceutical Inc.


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