NDC 68135-300

Kuvan

Sapropterin Dihydrochloride

Kuvan is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Biomarin Pharmaceutical Inc.. The primary component is Sapropterin Dihydrochloride.

Product ID68135-300_066f16a3-911d-43b6-950d-fde21585985b
NDC68135-300
Product TypeHuman Prescription Drug
Proprietary NameKuvan
Generic NameSapropterin Dihydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2007-12-14
Marketing CategoryNDA / NDA
Application NumberNDA022181
Labeler NameBioMarin Pharmaceutical Inc.
Substance NameSAPROPTERIN DIHYDROCHLORIDE
Active Ingredient Strength100 mg/1
Pharm ClassesPhenylalanine Hydroxylase Activator [EPC],Phenylalanine Hydroxylase Activators [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 68135-300-02

120 TABLET in 1 BOTTLE (68135-300-02)
Marketing Start Date2007-12-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68135-300-02 [68135030002]

Kuvan TABLET
Marketing CategoryNDA
Application NumberNDA022181
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-12-14

NDC 68135-300-01 [68135030001]

Kuvan TABLET
Marketing CategoryNDA
Application NumberNDA022181
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-12-14
Marketing End Date2014-01-03

Drug Details

Active Ingredients

IngredientStrength
SAPROPTERIN DIHYDROCHLORIDE100 mg/1

OpenFDA Data

SPL SET ID:af38711e-8873-4790-a92d-4d583e23fb89
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1111018
  • 1653221
  • 1653217
  • 1486691
  • 1111020
  • 1486687

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Kuvan" or generic name "Sapropterin Dihydrochloride"

    NDCBrand NameGeneric Name
    68135-300KuvanSAPROPTERIN DIHYDROCHLORIDE
    68135-301KuvanSAPROPTERIN DIHYDROCHLORIDE
    68135-482Kuvansapropterin dihydrochloride
    43598-096JAVYGTORSapropterin Dihydrochloride
    43598-097JAVYGTORSapropterin Dihydrochloride
    31722-045sapropterin dihydrochloridesapropterin dihydrochloride
    31722-047Sapropterin dihydrochlorideSapropterin dihydrochloride
    31722-048Sapropterin dihydrochlorideSapropterin dihydrochloride
    43598-162Sapropterin DihydrochlorideSapropterin Dihydrochloride
    43598-477Sapropterin DihydrochlorideSapropterin Dihydrochloride
    43598-749Sapropterin DihydrochlorideSapropterin Dihydrochloride
    49884-720sapropterin dihydrochloridesapropterin dihydrochloride
    49884-873SAPROPTERIN DIHYDROCHLORIDESAPROPTERIN DIHYDROCHLORIDE
    49884-948SAPROPTERIN DIHYDROCHLORIDESAPROPTERIN DIHYDROCHLORIDE

    Trademark Results [Kuvan]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    KUVAN
    KUVAN
    78869434 3410811 Live/Registered
    Biomarin Pharmaceutical Inc.
    2006-04-25
    KUVAN
    KUVAN
    77699200 3783437 Live/Registered
    Biomarin Pharmaceutical Inc.
    2009-03-25
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