68135-301 : Kuvan 100 mg/1 Oral Powder, for Solution


NDC: 68135-301
Labeler: Biomarin Pharmaceutical Inc.
Product Type: Human Prescription Drug
Drug Name:  Kuvan
Dosage Form: Oral Powder, for Solution
Application #: NDA205065
Rev. Date: 


NDC Package Codes:

  • 68135-301-22: 30 PACKET IN 1 CARTON (68135‑301‑22) > 1 POWDER, FOR SOLUTION IN 1 PACKET (68135‑301‑11)

Active Ingredients:

  • Sapropterin Dihydrochloride

Dosage Strength:

  • 100 mg

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.
  • 68135-300 Kuvan 100 mg Oral Tablet for 4-8 Oz Oral Solution by Biomarin Pharmaceutical Inc.
  • 68135-482 Kuvan 500 mg Oral Powder, for Solution by Biomarin Pharmaceutical Inc.

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.